Approval of Medical Devices

European Union • Australia • Brazil • Canada • China

France • Germany • Israel • Japan • Mexico 

Netherlands • Russian Federation • South Africa 

Spain • Switzerland • United Kingdom

September 2014

The Law Library of Congress, Global Legal Research Center

(202) 707-6462 (phone) • (866) 550-0442 (fax) • law@loc.gov • http://www.law.gov
This report is provided for reference purposes only. 

It does not constitute legal advice and does not represent the official 

opinion of the United States Government. The information provided 

reflects research undertaken as of the date of writing. 

It has not been updated.
Approval of Medical Devices

Prepared by the Staff of the Global Legal Research Center

SUMMARY This report describes the approval process for medical devices in the European Union and 

fifteen countries, and also indicates whether or not an expedited approval procedure is 

available. Many of the countries reference EU law, including France, Germany, the 

Netherlands, and Switzerland. Israel more readily approves devices with a CE mark 

(indicating approval in the EU) or an indication that they are approved by the US Food and 

Drug Administration (FDA). In many nations, particularly those influenced by the EU, 

part of the review process is conducted not by the government but by private, independent 

organizations called “notified bodies.” These organizations are designated by EU 

Member States.

In most of the countries in the survey, medical devices are categorized based on the risks 

associated with their use, and the approval process varies by category. For example, in the 

United Kingdom, manufacturers of low-risk devices may register with the government 

agency and simply declare that the devices meet the requirements to be approved. Devices 

classed as higher risk must undergo more detailed review, by a notified body. 

On the question of an expedited approval process, Australia, Canada, China, Japan, Spain, 

and Switzerland permit some sort of rapid review in particular cases, often when a device 

is required for an individual patient and no substitute is available. Mexico has provided 

for more rapid approval of devices if they have already been approved in either Canada or 

the United States. No such procedure exists at present in Brazil, France, Israel, the 

Russian Federation, or the United Kingdom. The Russian Federation did have a rapid 

approval system in place prior to August 2014. Germany provides for temporary approval 

of devices in limited circumstances. South Africa is now considering draft legislation that 

would include expedited procedures in specified situations. The map included at the end 

of this report provides a visual overview of the status of expedited approval in the 

countries surveyed.

I. European Union

A. Current Medical Device Approval Process

The current European Union (EU) regulatory framework governing medical devices1 includes 

Council Directive 90/385/EEC on Active Implantable Medical Devices2 and Council Directive 

93/42/EEC on Medical Devices.3 In vitro diagnostic medical devices are governed by Directive 

1 See LAW LIBRARY REPORT FOR CONGRESS: EUROPEAN UNION REGULATION OF MEDICAL DEVICES (LL File No. 

2011-005058) (Dec. 2010) (on file with author). 

2 Council Directive 90/385/EEC of 20 June 1990 on the Approximation of the Laws of the Member States Relating 

to Active Implantable Medical Devices, 1990 O.J. (L 189) 17, as amended, http://eur-lex.europa.eu/legal-content/ 

EN/TXT/PDF/?uri=CELEX:01990L0385-20071011&rid=1. 

3 Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, 1993 O.J. (L 169) 1, http://eurlex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01993L0042-20071011&rid=1, as amended by Directive 

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98/79/EC.4

 Medical devices must be in conformity with the rules established by these directives 

prior to being marketed and/or put into service in the EU, the European Economic Area, or 

Switzerland. At the EU level, there is no centralized approach similar to that in the United 

States.5 The European Medicines Agency of the EU, unlike the Federal Drug Administration in 

the United States, is not involved in the approval process of medical devices. Manufacturers, 

prior to placing their devices in the market, are required to determine the classification of a 

device, based on the risk factors associated with each device, and then to apply the appropriate 

conformity route. Medical devices are assessed for efficacy and safety by notified bodies, which 

are private organizations staffed by experts and certified by the EU Member States. In the final 

stage, medical devices, with some exceptions for such things as custom made devices and 

devices intended for clinical investigation, are given a CE marking, which ensures that medical 

devices are in conformity with EU rules and are ready to be marketed.6

EU Members are in charge of implementing the legislation and taking any measures required to 

ensure that medical devices meet the required criteria prior to being marketed in the EU and/or 

put into service.7 Medical devices and in vitro medical devices produced in third countries 

(outside the EU) must conform with the EU legislation. 

1. Classification Rules

The first step in the approval process is taken by the manufacturer, who is required to determine 

the class of its medical device in order to apply the appropriate conformity assessment rule. 

Medical devices are classified on a “risk-based” system.8 The classification rules of medical 

devices, as established in Annex IX of Directive 93/42/EEC on Medical Devices, depend on the 

vulnerability of the human body, taking into account possible dangers inherent in the technical 

design and manufacture of the devices.9

Medical devices are grouped into four product classes: I, IIa, IIb, and III. Application of the 

classification rules is based on the intended purpose of the devices. Most devices fall within the 

classification rules, except for a small number of products that are difficult to classify, such as 

borderline products or those with an unusual nature. Classification rules are in conformity, to a 

2007/47/EC of the European Parliament and of the Council of 5 September 2007, art. 3, 2007 O.J. (L 247) 21, 

http://ec.europa.eu/health/medical-devices/files/revision_docs/2007-47-en_en.pdf.

4 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic 

Medical Devices, 1998 O.J. (L 331) 1, http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01998 

L0079-20120111&rid=1.

5 BOSTON CONSULTING GROUP, REGULATION AND ACCESS TO INNOVATIVE MEDICAL TECHNOLOGIES: A

COMPARISON OF THE FDA AND EU APPROVAL PROCESSES AND THEIR IMPACT ON PATIENTS AND INDUSTRY (2012),

http://www.eucomed.org/uploads/ModuleXtender/Newsroom/97/2012_bcg_report_regulation_and_access_to_innov

ative_medical_technologies.pdf.

6 Directive 93/42/EEC, supra note 3, art. 4.

7 Id. art. 2. 

8 Id. art. 9. 

9 Id., Annex IX. 

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large extent, with the classification rules established by the Global Harmonization Task 

Force (GHTF).10

2. Approval Process

In general, all devices must meet the essential requirements irrespective of the class of the 

devise, be subject to the reporting requirements under the national supervisory system, and be 

CE marked, except custom-made devices and those intended for clinical investigation.11 Clinical 

data are also required to ensure conformity with the requirements of the Medical Devices 

Directive12 for class III devices and implantable medical devices.13 The affixing of a CE 

marking on medical devices, which is the last stage in the approval process, indicates that those 

medical devices conform with the requirements provided for in the legislation. The legal value 

of the CE marking lies in its proof that the medical device concerned is in full compliance with 

applicable legislation. On the other hand, the CE marking does not represent quality, even 

though consumers often assume that products bearing the CE marking are of better quality 

than others.

For economic and practical reasons, medical devices are subject to a graduated system of control, 

whereby the level of control corresponds to the level of danger inherent in the type of device 

involved.14 For class I devices, the conformity assessment procedure can be carried out by the 

manufacturer alone, due to the low level of risk associated with such products. For class IIa 

devices, the intervention of a notified body is mandatory at the production stage. For devices 

falling under classes IIb, such as implants and contraception products, and III, which pose a high 

risk, the notified body is tasked with being involved in the design and manufacture of 

the devices.15

Notified bodies play a vital role in the approval process since they are tasked to ascertain that 

medical devices marketed in the EU meet all requirements pursuant to the class assigned. 

Notified bodies are conformity assessment bodies, staffed by experts and designated as such by 

Member States. The Member States must report the names of the notified bodies to the 

Commission, which publishes a list of the bodies, along with the tasks assigned to them.16 Their 

accreditation and monitoring is conducted by the EU Members.17

10 Id. art. 9 & Preamble. 

11 European Commission, DG Enterprise, Guidelines for the Classification of Medical Devices 4, MEDDEV 2.4/1 

Rev. 8, July 2001, http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf. 

12 Directive 93/42/EEC, supra note 3, Annex I. 

13 Id., Annex X.

14 European Commission, supra note 11, at 2.

15 Directive 93/42/EEC, supra note 3, Preamble. 

16 Id. art. 16; Directive 90/385/EEC, supra note 2, art. 11.

17 Commission Implementing Regulation (EU) No. 920/2013 of 24 September 2013 on the Designation and the 

Supervision of Notified Bodies Under Council Directive 90/385/EEC on Active Implantable Medical Devices and 

Council Directive 93/42/EEC on Medical Devices, 2013 O.J. (L 253) 8, http://eur-lex.europa.eu/LexUriServ/LexUri 

Serv.do?uri=OJ:L:2013:253:0008:0019:EN:PDF.

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B. Pending Legislation 

In 2012, the European Commission, due to diverging interpretations and applications of the legal 

regime on medical devices by the Members, new technological developments, and the public 

concerns raised by the scandal of a French manufacturer using industrial silicone for breast 

implants in France, moved to reform the legislation on medical devices.18 In brief, the pending 

legislation establishes new rules on the traceability of medical devices back to the suppliers; 

stronger supervision of independent conformity assessment bodies (notified bodies) by national 

authorities; and additional powers for notified bodies vis-à-vis the manufacturers, including 

unannounced inspections in factories.19

A number of Member States urged the Parliament to establish a centralized EU premarketing 

approval process along the lines of the US system. It appears that the Parliament has not 

introduced such a procedure.20 The proposal is expected to be adopted in 2014 and would 

gradually be implemented between 2015–2019.21

II. Individual Country Surveys

Australia

Pursuant to the Therapeutic Goods Act 1989 (Cth) and relevant regulations,22 the Therapeutic 

Goods Administration (TGA) makes decisions regarding the market authorization of medical 

devices that are “imported, exported, manufactured, and supplied in Australia.”23 The legislative 

framework “adopts the philosophies of the Global Harmonization Task Force (GHTF), an 

international forum that was established to achieve greater uniformity between national medical 

18 Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, COM (2012) 542 

final, http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf; Proposal for a 

Regulation for In Vitro Diagnostic Medical Devices, COM (2012) 541 final, http://ec.europa.eu/health/medicaldevices/files/revision_docs/proposal_2012_541_en.pdf.

19 Press Release, European Commission, Safer, More Effective and Innovative Medical Devices (Sept. 26, 2012), 

http://ec.europa.eu/health/medical-devices/files/revision_docs/pr_20120926_en.pdf. 

20 EU Parliament Stops Short of U.S.-Style Approvals for Medical Devices, REUTERS (Oct. 22, 2013), 

http://www.reuters.com/article/2013/10/22/us-eu-medtech-idUSBRE99L0TH20131022.

21 European Commission, Memo, Questions and Answers: Commission Tables Proposals for a New EU Regulatory 

Framework for Medical Devices and In Vitro Diagnostic Medical Devices (Sept. 26, 2012), http://ec.europa.eu/ 

health/medical-devices/files/revision_docs/qa_20120926_en.pdf.

22 Therapeutic Goods Act 1989 (Cth), http://www.comlaw.gov.au/Details/C2014C00410; Therapeutic Goods 

Regulations 1990 (Cth), http://www.comlaw.gov.au/Details/F2014C00898; Therapeutic Goods (Medical Devices) 

Regulations 2002 (Cth), http://www.comlaw.gov.au/Details/F2014C00912. 

23 TGA Key Performance Indicators: January to June 2014: 2. Premarket Business Operations, THERAPEUTIC 

GOODS ADMINISTRATION (TGA) (Aug. 2014), http://www.tga.gov.au/about/tga-kpi-1406-02-premarket.htm.

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device regulatory systems.”24 The TGA also negotiates agreements with other international 

regulators, which include acceptance of decisions on specific products from some countries.25 

The approval processes and regulatory requirements are explained in detail in the Australian 

Regulatory Guidelines for Medical Devices.

26 The requirements may vary “depending on what 

the device is and how it is to be used,” and the level of assessment performed by the TGA 

“directly relates to the level of potential risk.”27 This is managed through the categorization of 

devices into different classes by manufacturers in accordance with the relevant rules.28 

In order for a medical device to be supplied for sale in Australia, the sponsor must apply to have 

it listed in the Australian Register of Therapeutic Goods (ARTG).29 Broadly, before doing so, 

the sponsor must be able to provide “conformity assessment evidence”30 that demonstrates 

compliance with the “Essential Principles,”31 which are the product requirements for the quality, 

safety, and performance of the device.32 For devices other than “Class I non-sterile and nonmeasuring devices,” the sponsor must submit relevant evidence to the TGA as part of the 

process.33 If the device is manufactured overseas, the manufacturer obtains conformity 

assessment evidence from the TGA or an EU Notified Body and submits this to the TGA.34 The 

TGA randomly selects some applications for a detailed application audit.35 Applications related 

to specific high-risk devices must undergo a mandatory application audit.36 For Class I 

nonsterile and nonmeasuring devices, the manufacturer prepares technical documentation and a 

Declaration of Conformity, but this information does not need to be submitted with an 

application to include the device in the ARTG.37 

24 TGA, AUSTRALIAN REGULATORY GUIDELINES FOR MEDICAL DEVICES (ARGMD): PART 1 – INTRODUCTION 18 

(version 1.1, May 2011), http://www.tga.gov.au/pdf/devices-argmd-p1-01.pdf. Pages 147 to 158 of this document 

provide information on differences between the European Union and Australian regulatory systems.

25 Id. at 21, 159–62. As of March 2011, agreements were in place with Canada, Europe, Singapore, Switzerland, 

and the United States, and there were also cooperative arrangements with other regulators to share information on 

regulatory practices. Id. at 160.

26 The full document is available on the TGA website, at http://www.tga.gov.au/industry/devices-argmd.htm (last 

updated Jan. 29, 2013).

27 ARGMD: PART 1, supra note 24, at 20–21. 

28 Id. at 21, 74–104. The rules for classifying medical devices are contained in schedule 2 of the Therapeutic Goods 

(Medical Devices) Regulations 2002 (Cth).

29 Id. at 27.

30 Id. at 105–46. 

31 Id. at 27, 21, & 39–73. 

32 Id. at 21.

33 Id. at 27 & 30.

34 Id. at 140–43.

35 Id. at 30–31, 37; see also TGA, ARGMD: PART 2 – PRE-MARKET 187–97 (version 1.1, May 2011), http://www. 

tga.gov.au/pdf/devices-argmd-p2.pdf.

36 ARMGD: PART 1, supra note 24, at 22–23.

37 Id. at 29; see also ARMGD: PART 2, supra note 35, at 174.

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A Special Access Scheme “allows individual patients, with the support of their medical 

practitioner, access to unapproved devices in a range of circumstances.”38 This includes early 

access for terminally ill patients “to almost any device” without TGA approval.39 Personal 

importation of devices not included in the ARTG is also possible under the law.40

The TGA has established target time frames for the processing of medical device market 

authorization applications. In its latest report, covering January to June 2014, the TGA stated 

that it had processed all the conformity assessments within the target time frame of 255 days. 

Thirty-eight percent of noncompulsory Application Audits were processed within the target time

frame of thirty working days. In addition, 60% of Level 1 Application Audits were processed 

within thirty working days, and 60% of Level 2 Application Audits were processed within sixty 

working days.41

The TGA is currently implementing “a series of medical device regulatory reforms increasing 

the rigour of pre-market assessment of higher risk medical devices, to assure the quality, safety 

and performance of these devices.”42 Information about key reforms can be found on the 

TGA website.

Brazil 

Article 12 of Law No. 6,360 of September 23, 1976, determines that no product of interest to 

health, whether domestic or imported, can be industrialized, marketed, or delivered to the

consumer in the Brazilian market before being registered with the Ministry of Health.43 The 

registration is valid for five years, may be renewed for equal and successive periods of time, and 

keeps the initial registration number.

44 The registration must be awarded within ninety days 

from the date of submission of the registration request, except in cases of breach of Law No. 

6,360 or its regulations.

The National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), 

a federal agency subordinated to the Ministry of Health, is in charge of regulating, controlling, 

and supervising products and services that pose a risk to public health.45 

38 ARMGD: PART 2, supra note 35, at 286.

39 Id.

40 Id. at 290.

41 TGA Key Performance Indicators: January to June 2014: 2. Premarket Business Operations, supra note 23.

42 Medical Device Reforms, TGA (July 4, 2014), http://www.tga.gov.au/industry/devices-reforms.htm. 

43 Lei No. 6360, de 23 de Setembro de 1976, art. 12, http://www.planalto.gov.br/ccivil_03/Leis/L6360.htm. 

44 Id. art. 1(§1).

45 Lei No. 9.782, de 26 de Janeiro de 1999, art. 8, http://www.planalto.gov.br/ccivil_03/Leis/L9782compilado.htm. 

See also arts. 7(IX), 8(§1)(VI).

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On October 22, 2001, ANVISA issued Resolution RDC No. 185, which regulates the registration 

of medical devices and classifies them into four classes of risk associated with their use.

46 The 

process of registering a medical device incudes filing a registration request with ANVISA, along 

with a series of documents and information described in Resolution RDC No. 185 and other 

relevant laws. No provision to expedite the procedure is available.47

Canada

Medical devices are defined in the Food and Drugs Act,

48 which “covers a wide range of health 

or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or 

abnormal physical condition.”49 The approval process for medical devices is regulated by the 

Medical Devices Regulations.

50 Approvals are made by the Medical Devices Bureau of the 

Therapeutic Products Directorate (TPD), “the national authority that monitors and evaluates the 

safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.”51 

The TPD operates under Health Canada. In Canada, 

certain devices must have a Medical Device Licence before they can be sold. To 

determine which devices need a Licence, all medical devices have been categorized 

based on the risk associated with their use. This approach means that all medical devices 

are grouped into four classes with Class I devices presenting the lowest potential risk 

(e.g. a thermometer) and Class IV devices presenting the greatest potential risk 

(e.g. pacemakers).52

Health Canada outlines three steps in the approval process:

1. When a company decides that it would like to market a medical device in Canada, it 

submits a Medical Device Licence Application. The amount of information that must 

be submitted varies depending on the class of the device.

2. The TPD reviews the application.

46 MINISTÉRIO DA SAÚDE, ANVISA, Resolução RDC No. 185, de 22 de Outubro de 2001, Anexo [ANNEX], 

Regulamento Técnico [Technical Rules], Part 2, § 1, http://portal2.saude.gov.br/saudelegis/leg_norma_ 

espelho_consulta.cfm?id=3727179&highlight=&tipoBusca=post&slcOrigem=0&slcFonte=0&sqlcTipoNorma=186

&hdTipoNorma=186&buscaForm=post&bkp=pesqnorma&fonte=0&origem=0&sit=0&assunto=&qtd=10&tipo_nor

ma=186&numero=185&data=%20&dataFim=&ano=&pag=1 (access full text of Resolution by clicking on “Texto 

completo”). 

47 Id. Part 3, § 4.

48 Food and Drugs Act, R.S.C., 1985, c. F-27, http://laws-lois.justice.gc.ca/eng/acts/f-27/. For a definition of 

“device,” see id. § 2. 

49 Medical Devices, HEALTH CANADA, http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php (last updated 

July 7, 2014).

50 Medical Devices Regulations, SOR/98-282, http://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/FullText. 

html. “ ‘[M]edical device’ means a device within the meaning of the Act, but does not include any device that is 

intended for use in relation to animals.” Id. § 1.

51 Safe Medical Devices in Canada, HEALTH CANADA, http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/fs-fi/med 

devfs_matmedfd-eng.php (last updated July 7, 2014).

52 Id.

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3. If the information provided meets the requirements of the Medical Devices 

Regulations, a Licence is issued.53

According to Health Canada, the “length of the review varies depending on the class of the 

device, Class III & IV Licence applications have a target review time of 75 days and 90 days 

respectively and Class II Licence applications have a 15 calendar day target.”54 In Canada, a 

priority review can be granted to Class III or Class IV medical device license applications if they 

meet a certain criteria, including if the “product is intended for the treatment, prevention or 

diagnosis of very serious illnesses or conditions.”55 These priority review applications have a 

target review time of forty-five days, including screening and review time.56 Canada also has a 

Special Access Programme (SAP), which “allows doctors to gain access to medical devices that 

have not been licenced in Canada. The SAP is used in emergency situations or when 

conventional therapies have failed, are unavailable, or are unsuitable to treat a patient.”57

China

In China, medical devices are classified into three categories according to their risk levels and 

are regulated by the China Food and Drug Administration (CFDA). The categories are Class I: 

low-risk devices; Class II: moderate-risk devices; and Class III: high-risk devices.58 A listing 

process is applied to Class I medical devices, which requires only the submission of specified 

materials for records. Class II and Class III medical devices are subject to a mandatory

registration process prior to marketing.59 In order to receive approval from the food and drug 

authorities to register Class II or Class III devices, registration, inspections, and clinical tests 

must be conducted.60 Some Class II and Class III devices may be exempted from the 

53 Id. Requirements for application for a medical device license are stipulated under § 32 of the Medical Devices 

Regulations, supra note 50. For documents that explain “why Health Canada authorized certain medical devices for 

sale in Canada,” see Summary Basis of Decision (SBD) Documents: Medical Devices, HEALTH CANADA,

http://www.hc-sc.gc.ca/dhp-mps/prod pharma/sbd-smd/md-im/index-eng.php (last updated Aug. 1, 2014). 

54 Safe Medical Devices in Canada, supra note 51.

55 MCMILLAN LLP, HEALTH LAW IN CANADA 3 (2010), http://www.mcmillan.ca/files/Health_Law_in_Canada.pdf.

56 Management of Applications for Medical Device Licences and Investigational Testing Authorizations, HEALTH 

CANADA, http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/pol/mdlapp_demhim_pol-eng.php (last modified 

Feb. 4, 2014). There is also an Interim Policy on Priority Review of Medical Device Licence Applications but it 

appears to be unavailable online, and may be under review. 

57 Safe Medical Devices in Canada, supra note 51; see also Medical Devices – Special Access Programme, HEALTH 

CANADA, http://www.hc-sc.gc.ca/dhp-mps/acces/md-im/index-eng.php (last updated Mar. 13, 2013).

58 Yiliao Qixie Jiandu Guanli Tiaoli [Regulations on the Supervision and Administration of Medical Devices] 

(promulgated by the State Council, Mar. 7, 2014, effective June 1, 2014), art. 4, Central People’s Government 

official website, http://www.sda.gov.cn/WS01/CL0784/97814.html English translation provided by Westlaw China 

(by subscription).

59 Yiliao Qixie Zhuce Zhuce Guanli Banfa [Administrative Measures for the Registration of Medical Devices] 

(promulgated by the CFDA, July 30, 2014, effective Oct. 1, 2014), arts. 3 & 5, CFDA official website, http://www. 

sda.gov.cn/WS01/CL0053/103756.html, English translation provided by Westlaw China.

60 Id. arts. 16 & 22.

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requirement of clinical tests; the CFDA maintains and publishes a list of devices that may 

be exempted.61

Under the registration process, within three workdays of receiving the application, the food and 

drug authorities must pass on the application materials to a technical review institute. The 

technical review institute has sixty workdays to review a Class II medical device and ninety 

workdays to review a Class III device.62 The authorities must make the decision on whether to 

approve the device within twenty workdays after the completion of the technical review and 

issue the medical device registration certificate to the applicant within ten workdays from the day 

the approval decision was made, if the application complies with the registration requirements.63

An emergency approval process is available that applies to medical devices urgently needed to 

respond to public health emergency incidents.64 Under this process, the CFDA has three days to 

decide if an emergency approval process may be launched.65 For Class I devices, the technical 

review and administrative review by the food and drug authorities must be completed within five 

days. The technical review of Class II devices must be completed within five days, and the limit 

is ten days for Class III devices. Upon completion of the technical review, the food and drug 

authorities have another three days to approve a Class II or Class III device.66 

France

Approval of medical devices in France is closely based on European Union regulations.67 

Medical devices must have the CE label, indicating conformity with European standards.68

Medical devices are divided into four product classes (I, IIa, IIb, and III) according to their level 

of risk.69 Medical devices in Class I (with the lowest level of risk) that do not need to be sterile 

can be auto-certified by the manufacturer.70 All other medical devices must be assessed by a 

special body (called a “notified body”) approved by the European Commission and the Agence 

61 Id. art. 22.

62 Id. art. 33.

63 Id. art. 36.

64 Yiliao Qixie Yingji Shenpi Chengxu [Emergency Procedures for Examination and Approval of Medical Devices] 

(promulgated by the CFDA, Aug. 28, 2009), http://www.sda.gov.cn/WS01/CL0055/41117.html, English translation 

provided by Westlaw China.

65 Id. art. 6.

66 Id. arts. 11–13.

67 HAUTE AUTORITÉ DE SANTÉ [HEALTH HIGH AUTHORITY], PARCOURS DU DISPOSITIF MEDICAL, GUIDE PRATIQUE 

[THE MEDICAL DEVICE’S PATH: PRACTICAL GUIDE] 9 (2013), http://has-sante.fr/portail/upload/docs/application/pdf/ 

2009-12/guide_pratique_dm.pdf.

68 CODE DE LA SANTE PUBLIQUE [CODE OF PUBLIC HEALTH] art. R5211-12, http://www.legifrance.gouv.fr/ 

affichCode.do;jsessionid=C412D9EC284C4DC0E965EA268D88AF72.tpdjo14v_1?cidTexte=LEGITEXT00000607

2665&dateTexte=20140908; PARCOURS DU DISPOSITIF MEDICAL, supra note 67, at 9.

69 CODE DE LA SANTE PUBLIQUE art. R5211-7; PARCOURS DU DISPOSITIF MEDICAL, supra note 67, at 10.

70 PARCOURS DU DISPOSITIF MEDICAL, supra note 67, at 10.

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nationale de sécurité du médicament (National Agency for Medication Safety).71 The 

assessment involves an audit of the manufacturer’s quality control system and an inspection of 

the design dossier, which should include clinical data.72 The approval of most Class III devices 

(with the highest level of risk) requires clinical trials.73 There does not appear to be any special 

procedure for expedited approval. The CE certificate is valid for a maximum of five years, but is 

renewable.74 Follow-up audits are undertaken even after the certificate is issued, and another indepth audit is done before it can be renewed.75

Germany

With the exception of custom-made devices and medical devices manufactured in-house, 

medical devices pursuant to section 11(1) of the Act on Medical Devices (Medizinproduktgesetz, 

MPG)76 and medical devices intended for clinical investigation, or in vitro diagnostic medical 

devices intended for performance evaluation, may only be placed on the market or put into 

service in Germany if the essential requirements and the conformity assessment procedure 

prescribed for the medical device have been conducted.77 These requirements are directed by 

EU law.78 Devices are classified according to the risk they pose to the patient.79 Unlike 

medicinal products, medical devices do not undergo an official authorization procedure. Certain 

low-risk medical devices can, for example, be assessed by the manufacturing company itself.80

Devices with higher risks are to be certified by so-called “Notified Bodies,” private entities that 

are certified by the EU Member States.81 The time for issuing a certification by the Notified 

Bodies is variable.82 In 2012, 56% of all newly admitted medical devices on the German market 

71 Id.; CODE DE LA SANTE PUBLIQUE art. L5211-3; Mise sur le marché des dispositifs médicaux et dispositifs 

médicaux de diagnostic in vitro [Market Introduction of Medical Devices and In Vitro Diagnostic Medical Devices], 

AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE [NATIONAL AGENCY FOR 

MEDICATION AND HEALTH PRODUCTS SAFETY], http://ansm.sante.fr/Activites/Mise-sur-le-marche-des-dispositifsmedicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/Mise-sur-le-marche-des-dispositifsmedicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro-DM-DMIA-DMDIV/%28offset%29/0 (last visited 

Sept. 8, 2014).

72 PARCOURS DU DISPOSITIF MEDICAL, supra note 67, at 11.

73 Id.

74 Id.

75 Id.

76 MEDIZINPRODUKTEGESETZ [ACT ON MEDICAL DEVICES], Aug. 7, 2002, BUNDESGESETZBLATT [BGBL.] I at 3146, 

as amended through Act of July 21, BGBL. I at 1133, http://www.gesetze-im-internet.de/bundesrecht/mpg/ 

gesamt.pdf. 

77 Id. § 6(1).

78 Council Directive 93/42/EEC, supra note 3; Council Directive 90/385/EEC, supra note 2; Directive 98/79/EC, 

supra note 4.

79 See, e.g., Council Directive 93/42/EEC, supra note 3, Annex IX.

80 Id., Annex VII.

81 Id. art. 16.

82 AOK-BUNDESVERBAND, MEDIZINPRODUKTE – MYTHEN UND WAHRHEIT: GEMEINSAMES 

ARGUMENTATIONSPAPIER VON DEN SPITZENVERBÄNDEN DER GESETZLICHEN KRANKENKASSEN IN DEUTSCHLAND 

[MEDICAL DEVICES – MYTHS AND TRUTH: COLLECTIVE ARGUMENTATION PAPER OF THE CENTRAL FEDERAL 

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could undergo assessment by the manufacturer.83 Research shows that the European concept of 

certification offers quick access to the market, which especially benefits small- and mid-sized

businesses.84

However, Germany’s Federal Institute for Drugs and Medical Devices may issue a temporary 

permission for certain medical devices in the interest of health protection. This temporary 

permission is valid for Germany only and may only be granted if the regular assessment 

procedure cannot be completed. The temporary permission is also not available when substitute 

medical devices exist.85 Research indicates, however, that temporary permissions are not often 

demanded, since the permission is valid for Germany only and the process is considered slower 

than the regular assessment.86

Israel

Israel’s Medical Devices Law, 5772-2012, generally requires the registration of all medical 

products as a precondition for production and distribution.87 Special exemptions may apply 

under limited circumstances and for purposes such as the provision of essential medical 

treatment, research, development and manufacturing of the medical device, and personal use, 

among other.88 

Registration of medical devices requires the submission of an application to the Ministry of 

Health Medical Institutions and Devices Licensing Department (known as AMAR).89 The 

application requires presentation of a list of documents,90 including, in the case of Israeli 

ASSOCIATION OF HEALTH INSURANCE FUNDS IN GERMANY] 7 (July 19, 2013), http://www.aok-bv.de/imperia/ 

md/aokbv/politik/versicherte/thesenpapier_gross_0713_dt.pdf. 

83 Bundesverband Medizintechnologie [German Federal Association of Medical Technology], Der lange Weg eines 

Medizinproduktes von der Idee bis zur Anwendung [The Long Way of a Medical Device from the Idea to the 

Application] (Feb. 2014), http://www.bvmed.de/download/poster-a2-der-lange-weg-eines-medizinproduktes-vonder-idee-bis-zur-anwendung (diagram). 

84 FEDERAL MINISTRY OF HEALTH, MARKTZUGANGSVORAUSSETZUNGEN FÜR MEDIZINPRODUKTE –

ZUSTÄNDIGKEITEN IN DEUTSCHLAND [MARKET ACCESS CONDITIONS FOR MEDICAL DEVICES – COMPETENCES IN 

GERMANY] 2 (June 2010), http://www.bmg. bund.de/fileadmin/dateien/Downloads/M/Medizinprodukte/Medizin_ 

Produkte_Marktzugangsvoraussetzungen_fuer_Medizinprodukte.pdf.

85 ACT ON MEDICAL DEVICES § 11(1), Aug. 7, 2002, BGBL. I at 3146, as amended through Act of July 21, BGBL. I 

at 1133, http://www.gesetze-im-internet.de/bundesrecht/mpg/gesamt.pdf. 

86 Andrea B. Gall, Vergleich von Medizinproduktegesetz und Arzneimittelgesetz unter besonderer Berücksichtigung 

des Inverkehrbringens und der klinischen Prüfung 104 (Dissertation, University of Bonn, 2009), http://hss.ulb. unibonn.de/2010/2135/2135.pdf.

87 Medical Devices Law, 5772-2012, SEFER HAHUKIM (Book of Laws, Official Gazette), p. 394.

88 Id. § 4.

89 See Medical Institutions and Devices Licensing Department, AMAR, http://www.health.gov.il/English/Ministry 

Units/HealthDivision/MedicalTechnologies/AMAR/Pages/default.aspx (last visited Sept. 5, 2014).

90 See Medical Devices (Registration of a Medical Device in the Register and its Renewal) Regulations, 5773-2013, 

§ 3, KOVETZ HATAKANOT [KT] No. 7258, p. 1311.

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manufactured devices that are not registered or authorized in any “recognized country,”91 a risk 

analysis, a clinical evaluation, a summary of the clinical trials, and expert opinions regarding the 

device’s safety and usefulness. Additional requirements may apply during the registration 

period, including follow-up reviews, to improve the quality and safety of the devices.92

According to regulations issued by Israel’s Minister of Health in June 2013, a decision on a 

request to register a medical device must be delivered within 120 days from the date of the 

request.93 This period may be further extended if additional information or documentation is 

requested. The current rules for the registration of medical devices do not provide for an 

expedited approval process. 

According to information posted on the website of a regulatory consulting firm, however, 

medical devices without a CE-Mark or FDA-approval are rarely issued a license, [but] 

[d]evices with both CE-Mark and FDA-approval will often meet the requirements of 

AMAR without delay.

The official timeframe for registration in Israel is 120 days, however, registration is 

usually completed within 6–9 months because the authorities will often require further 

documentation in the course of their evaluation. If [in] the documentation, for example a 

clinical trial, is not provided within 45 calendar days, the application will be voided. 

AMAR is currently undergoing efforts to reduce registration times that have been 

lengthened by current practices.94

Japan

The Japanese Pharmaceutical Affairs Law defines medical devices as “devices, etc. intended for 

use in diagnosis, treatment or prevention of disease in humans or animals, or intended to affect 

[the] structure or functions of [the bodies] of humans or animals, and which are designated by 

Cabinet Order.”95 In order to engage in marketing medical devices, companies are required to 

obtain marketing business (Marketing Authorization Holder, MAH) licenses.96 

91 A “recognized country” is defined in section 1 of the Medical Devices Law as one of the countries listed in the 

First Annex, including the US. Medical Devices Law, 5772-2012, § 1.

92 Id. § 7. 

93 Medical Devices (Registration of a Medical Device in the Register and its Renewal) Regulations § 5(a) (in 

Hebrew), KOVETZ HATAKANOT [KT] No. 7258, p. 1311.

94 Country at a Glance: Israel, ARAZY GROUP (MAY 30, 2013), http://arazygroup.com/blog/register-medical-devicein-israel/.

95 Pharmaceutical Affairs Law, Act No. 145 of 1960, last amended by Act No. 69 of 2014, art. 2, para. 4, translated 

in YAKUJIHŌ, YAKUJIHŌSHIKŌREI, YAKUJIHŌSHIKŌKISOKU, IYAKUHIN IRYŌKI SŌGŌKIKŌHŌ[PHARMACEUTICAL 

AFFAIRS LAW, ENFORCEMENT ORDINANCE, ENFORCEMENT REGULATIONS & LAW FOR THE PHARMACEUTICALS AND 

MEDICAL DEVICES AGENCY] 2009/2010 (Jiho Inc., 2009) (translated version of Act last amended by Act No. 84 

of 2006). 

96 Id. art. 12.

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Medical devices are classified as Class I, II, III or IV, according to their risk level. To market 

medical devices in Japan, the MAH must register the device through the following procedures:

97

Pre-market Submission (Todokede) – Class I Medical Devices

To register and market General Medical Devices (Class I devices),[98] the MAH only need 

to file Pre-Market Submission to the Pharmaceuticals and Medical Devices Agency 

(PMDA) with no assessment by the PMDA.[99]

Pre-market Certification (Ninsho) – Class II Medical Devices

Class II devices which are described as Specified Controlled Devices[100] are subject to 

Pre-Market Certification. To register and market a Specified Controlled Medical Device, 

the MAH needs to file a Pre-Market Certification application with a registered 

certification body (third party) and obtain their certification.[101]

Pre-market Approval (Shonin) – Classes II, III & IV Medical Devices

To register and market a Highly Controlled Medical Device,[102] the MAH needs to file a 

Pre-Market Approval Application with the PMDA[103] and obtain an approval from the 

Minister of Health, Labour and Welfare.[104]

 Class II devices that are not Specified 

Controlled Devices are also subject to Pre-Market Approval.

Japan’s Minister of Health, Labour, and Welfare may grant emergency approval upon 

consultation with the Pharmaceutical Affairs and Food Sanitation Council if a medical device 

satisfies both of the following conditions:

• The medical devices are required for use in emergencies to prevent the spread of diseases or 

other damage to health that might have major effects on the life and health of the public and 

for which no appropriate methods other than such drugs or medical devices exist; and

• the devices are authorized for sale, gift, storage, or exhibit for sale or gift by an authority of a 

foreign country (limited to countries which have a system of approval of medical devices for 

marketing that assures that the medical device has quality, efficacy and safety equivalent to 

those obtained in Japan, or an equivalent system, as specified by Cabinet Order).105 

97 Japan PMDA Medical Device Approval and Certification, EMERGO, http://www.emergogroup.com/services/ 

japan/medical-device-approval-japan (last visited Sept. 8, 2014). See also, Atsushi Tamura, Understanding Japanese 

Medical Device Requirements, Presentation at 2011 AHC Workshop on Medical Devices (Seoul, Korea, July 4–5, 

2011), slide 9, http://www.pmda.go.jp/regulatory/file/english_presentation/device/D-E3tamura.pdf.

98 Pharmaceutical Affairs Law art. 2, para. 7. 

99 Id. art. 14-9.

100 Id. art. 2, para. 6.

101 Id. art. 23-2.

102 Id. art. 2, para. 5.

103 Id. art. 14-2.

104 Id. art. 14.

105 Id. art. 14-3.

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Mexico

Mexico’s Regulation of Health Supplies provides that medical devices require a sanitary 

registration in order to be produced, sold, and distributed.106 For purposes of registration, 

medical devices are classified into three categories depending on the level risk that their use 

entails, as follows:

• Class I: Devices known in medical practice and whose safety and efficacy are proven and, 

generally, are not introduced into the human body.

• Class II: Devices known in medical practice whose components may have variations and, 

generally, are introduced into the human body for less than thirty days.

• Class III: New devices or devices that have been recently accepted in medical practice, or 

devices that are introduced into the human body and stay there for more than thirty days.107

The registration procedure is administered by Mexico’s Federal Commission for the Protection 

Against Sanitary Risks (COFEPRIS), which is part of Mexico’s Federal Department of 

Health.108

In order to obtain the sanitary registration of medical devices, an application with supporting 

documentation must be submitted. The documentation must include

• scientific and technical information to demonstrate that the device is safe and effective;

• a proposal of the label in the Spanish language, pursuant to applicable regulations;

• if applicable, instructions or a manual for the use of the device in the Spanish language;

• a description of the manufacturing process of the device;

• a description of the structure, materials, parts, and functions of the medical device;

• information on laboratory tests conducted to verify the specifications of the device; and

• bibliographic references.109

Applications for “Class I” devices are processed in thirty days.110 If the processing of the 

application does not conclude in that period of time, the application is deemed approved.111

106 Reglamento de Insumos para la Salud [Regulation of Health Supplies], as amended through Mar. 2014, art. 82, 

DIARIO OFICIAL DE LA FEDERACIÓN [D.O.], Feb. 4, 1998, available on the website of Mexico’s Supreme Court, at

http://legislacion.scjn.gob.mx/reglamentos/Reformas.aspx?IdLey=11369. 

107 Id. art. 83.

108 Registros Sanitarios de Dispositivos Médicos [Sanitary Registration of Medical Devices], COMISIÓN FEDERAL 

PARA LA PROTECCIÓN CONTRA RIESGOS SANITARIOS, http://www.cofepris.gob.mx/AS/Paginas/Registros%2 

0Sanitarios/RegistroSanitarioDispositivosMedicos.aspx (last updated Sept. 3, 2014).

109 Reglamento de Insumos para la Salud, supra note 106, art. 179.

110 Id.

111 Id.

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Applications for approval of devices falling under Classes II and III should be processed in 

thirty-five and sixty days, respectively.112

The Mexican government has issued a Directive that allows for streamlined approval of medical 

devices in Mexico, provided that they have previously been approved by the US Food and Drug 

Administration (FDA) or by Health Canada (HC).113 The Directive indicates that the procedures 

followed by the FDA and HC in the approval of medical devices in the United States and Canada 

are equivalent to those provided by Mexican law.114 Therefore, applicants for approval of such 

devices may present evidence that they have been previously duly approved in the United States 

or Canada in order to streamline the process in Mexico.115 That process may take up to thirty 

business days, if such evidence is provided.116 

Netherlands

The United States is the largest producer of medical devices world-wide, but in Europe, 

according to 2012 figures, the Netherlands ranked second only to Germany in the volume of 

import and export trade in such devices.117 Regulation of medical devices in the Netherlands is 

governed by three European Union directives118 along with the Netherlands’ Medical Devices 

Act,

119 Medical Devices Decree,120 Active Implants Decree,121 and In-Vitro Diagnostics 

112 Id.

113 Directive that recognizes that the requirements set forth under articles 179 and 180 of the Regulations for Health 

Supplies, and that the technical assessment procedures carried out by Mexico’s Federal Commission for the 

Protection against Sanitary Risk are equivalent to grant the registration for health supplies under Chapter IX, Title 2 

of the Regulations for Health Supplies, to the requirements set forth under sections 510 (k) and 514 of the Federal 

Food, Drug and Cosmetic Act and by Title 21, Chapter 1, Subchapter H of the Code of Federal Regulations of the 

United States of America, as well as those set forth by the Food and Drug Act and the Medical Devices Regulations 

of Canada to allow to market medical devices in their territory, and to the tests and inspections carried out by the 

Food and Drug Administration of the United States of America and by Health Canada of Canada in order to allow to 

market medical devices in their territory, D.O. (Oct. 26, 2010), available on the website of COFEPRIS, at 

http://www.cofepris.gob.mx/AS/Paginas/Registro%20de%20Dispositivos%20Medicos%20por%20Equivalencia/Ma

rco-Legal.aspx. See also Registro de Dispositivos Médicos por Equivalencia, COMISIÓN FEDERAL PARA LA 

PROTECCIÓN CONTRA RIESGOS SANITARIOS, http://www.cofepris.gob.mx/AS/Paginas/Registro%20de%20 

Dispositivos%20Medicos%20por%20Equivalencia/Registros-de-Dispositivos.aspx (last visited Sept. 8, 2014).

114 Id.

115 Id.

116 Id.

117 Chart, Exports and Imports of Medical Technology by Country, 2012, in MEDTECH EUROPE, THE EUROPEAN 

MEDICAL TECHNOLOGY INDUSTRY IN FIGURES 7 (2013), http://www.eucomed.org/uploads/Modules/Publications/ 

the_emti_in_fig_broch_12_pages_v09_pbp.pdf.

118 Council Directive 93/42/EEC, supra note 3; Council Directive 90/385/EEC, supra note 2; Directive 98/79/EC, 

supra note 4. 

119 Wet van 15 januari 1970, houdende regelen met betrekking tot medische hulpmiddelen (Wet op de medische 

hulpmiddelen) (Jan. 15, 1970, as last amended, effective Feb. 15, 2014), http://wetten.overheid.nl/BWBR0 

002697/geldigheidsdatum_04-09-2014.

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Decree.122 In the Netherlands, the EU’s CE mark is obtained through review by its notified 

body, the Inspectorate for Health (Inspectie voor de Gezondheidsorg, IGZ), supported by the 

Medicines Evaluation Board.123 

Medical devices are classified and, for high-risk classifications, subject to notified body 

inspections in accordance with the EU Medical Devices Directive.124 Dutch manufacturers of 

medical devices who wish to market Class I (non-invasive devices) or in-vitro diagnostic (IVD)

medical devices must first register themselves and the product with the Ministry of Public 

Health, Welfare, and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) through the 

NOTIS system. This procedure also applies to the authorized representatives of non-EU 

manufacturers that have been established in the Netherlands.125 Medical devices registered with 

NOTIS are automatically registered with Eudamed, the European Union databank for medical 

devices.126 Medical devices not registered with NOTIS are to be registered by the notified 

bodies with the IGZ and then with Eudamed.127 

Farmatec, under the CIBG, an agency within the Ministry of Public Health, deals with 

applications for authorizations of manufacturing and wholesale distribution and handles Class I 

and low-risk IVD device registrations. Farmatec has ninety days from the date of receipt of an 

application to make a decision on it; if it cannot meet this deadline, it is obligated to so inform 

the applicant.128

No information was found on a fast-track procedure for medical devices in the Netherlands.

120 Besluit van 30 maart 1995, houdende regels met betrekking tot het in de handel brengen en het toepassen van 

medische hulpmiddelen, alsmede tot wijziging van enige algemene maatregelen van bestuur (Besluit medische 

hulpmiddelen) (Mar. 30, 1995, as last amended, effective Mar. 21, 2010), http://wetten.overheid.nl/BWB 

R0007307/geldigheidsdatum_04-09-2014.

121 Besluit van 5 juli 1993, houdende regels met betrekking tot het in de handel brengen van actieve implantaten 

(Besluit actieve implantaten) (July 5, 1993, as last amended, effective Mar. 21, 2010), http://wetten.overheid. 

nl/BWBR0006060/geldigheidsdatum_04-09-2014. 

122 Besluit van 22 juni 2001, houdende regels met betrekking tot het in de handel brengen en het toepassen van 

medische hulpmiddelen voor in-vitro diagnostiek (Besluit in-vitro diagnostica) (June 22, 2001, as last amended,

effective July 1, 2012), http://wetten.overheid.nl/BWBR0012610/geldigheidsdatum_04-09-2014. 

123 TTOPSTART B.V., CERTIFICATION AND REGISTRATION: MEDICAL DEVICES ON THE EUROPEAN MARKET 12 (Oct. 

2013), http://www.ttopstart.com/uploads/ttopstart_-_spottlight_-_Certification_and_registration_of_ 

medical_devices.pdf. 

124 Besluit medische hulpmiddelen art. 8 (1). However, breast implants and hip, knee, and shoulder replacements are 

classifed in Class III. Id. art. 8(2).

125 NOTIS, CIBG, https://hulpmiddelen.farmatec.nl/en/ (last visited Sept. 9, 2014).

126 TTOPSTART B.V., supra note 123, at 16.

127 Id.

128 Medicinal Product Regulation and Product Liability in The Netherlands: Overview, PRACTICAL LAW (Mar. 1, 

2014), http://uk.practicallaw.com/3-500-7575?service=crossborder.

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Russian Federation 

According to article 38 of the Federal Law on Fundamentals of Healthcare in the Russian 

Federation,129 only medical devices registered pursuant to a procedure established by the 

government can be used. The Law defines “medical devices” as any machines, equipment, 

instruments, or materials, including software, used for purposes of prevention, diagnosis, 

treatment, or rehabilitation of illnesses; monitoring human health; conducting medical research; a 

change or substitution of the human body’s anatomic structure or physiological functions; the 

prevention or termination of a pregnancy, all of which have no pharmacological, immunological, 

genetic, or metabolic impact on the human body.130

Government Regulation No. 1416 of December 27, 2012, implemented this provision of the Law 

and approved Rules for State Registration of Medical Devices.131 According to the Rules, 

devices created in response to specific requests of those patients who have special individual 

needs as defined by medical personnel and that will be used by the patient personally are exempt 

from government approval. All other devices are subject to the government registration process.

Registration is conducted by the Federal Service on Healthcare Supervision, a part of the Federal 

Ministry of Health Protection, and requires submission of an application and technical 

documentation for the device. Expert evaluation of the quality, effectiveness, and safety of each

device submitted for registration is required. This evaluation includes clinical testing. The 

Federal Service on Healthcare Supervision certifies individuals and institutions eligible to 

conduct the evaluations. A document entitled Administrative Procedures for State Registration 

of Medical Devices was issued by the Federal Service on Healthcare Supervision on October 14, 

2013, and entered into force on August 12, 2014.132 The Procedures established that state 

registration of medical devices cannot take longer than fifty business days; however, this period 

does not include the duration of the clinical testing and expert evaluation. Also, the fifty-day 

period stops running if errors are found in the documents submitted for registration, and the 

papers are returned to the applicant for correction.133

The current rules for the registration of medical devices do not provide for an expedited approval 

process. An opportunity for expedited approval was foreseen by the registration procedure that 

existed before August 12, 2014.134 Under the previous registration procedure, all medical 

devices were divided into four categories depending on the degree of potential risk associated 

with their usage. Devices of low- and medium-risk levels equivalent to their analogs were 

129 Federal Law No. 323 of Nov. 21, 2011, SOBRANIE ZAKONODATELSTVA ROSSIIKOI FEDERATSII [SZ RF] 

[COLLECTION OF RUSSIAN FEDERATION LEGISLATION] (official gazette, in Russian) 2011, No. 48, Item 6724. 

130 Id. 

131 SZ RF 2013, No. 1, Item 14. 

132 Order No. 737 of the RF Ministry of Health Protection, http://www.roszdravnadzor.ru/administrative_ 

regulations/approved?year=&page=1 (click on document No. 2, in Russian).

133 Id. §§ 12–14, 64. 

134 Order No. 735 of the RF Ministry of Healthcare and Social Protection of October 30, 2006, http://www. 

roszdravnadzor.ru/administrative_regulations/approved?year=&page=2 (click on document 2, in Russian).

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subject to a mandatory expedited approval process. Expedited approval required ultimate 

registration of medical devices within a two-month period, while the regular registration 

procedures continued for four months, with the possibility of a three-month extension.135

South Africa

South Africa does not have a comprehensive regulatory framework governing medical devices. 

At present, only listed electronic products (also known as electromagnetic medical devices or 

radiation emitting devices) must be registered before they can be sold, leased, used, operated, or 

applied in South Africa.136 A person interested in engaging in any of these activities involving 

electronic product must first apply to and obtain an approval from the Director General of the 

National Health and Population Development (the Director General).137 The Director General’s 

refusal to grant a license can be appealed to the Minister of National Health (the Minister).138 

However, the applicable laws do not appear to impose a particular time frame for the completion 

of the registration process or provide an option for fast-tracking the process. This is likely to 

change soon, however. 

In April 2014, South Africa published for public comment draft rules designed to regulate all 

medical devices.139 The draft regulations include a provision for a four-tiered, risk-based 

135 Id. § 3.3.1.

136 Hazardous Substances Act 15 of 1973, §§ 1, 3 & 4, available on the University of Pretoria website, at 

http://www.lawsofsouthafrica.up.ac.za/index.php/browse/medical-and-health/hazardous-substances-act-15-of1973/act/15-of-1973-hazardous-substances-act-24-feb-2000-to-date-pdf/download; Hazardous Substances Act 15 of 

1973: Regulations Relating to Group III Hazardous Substances § 2, Government Notice [GN] R690, 286 

GOVERNMENT GAZETTE [GG], No. 11823 (Apr. 14, 1989), http://www.lawsofsouthafrica.up.ac.za/index.php/ 

browse/medical-and-health/hazardous-substances-act-15-of-1973/regulations-and-notices/15-of-1973-hazardoussubstances-act-regs-gnr-690-14-apr-1989-to-date-pdf/download; Hazardous Substances Act 15 of 1973: Group III 

Hazardous Substances Schedule GN R1302, GG 13299 (June 14, 1991), http://www.lawsofsouthafrica.up.ac.za/ 

index.php/browse/medical-and-health/hazardous-substances-act-15-of-1973/regulations-and-notices/15-of-1973-

hazardous-substances-act-regs-gnr-1302-14-jun-1991-to-date-pdf/download. 

137 Hazardous Substances Act §§ 1, 3 & 4; Regulations Relating to Group III Hazardous Substances § 3. 

138 Hazardous Substances Act § 6; Regulations Relating to Group III Hazardous Substances § 4. 

139 This includes 

. . . any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent−

(a) used for purporting to be for the use or manufactured or sold for use in−

(i) the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical 

or mental states or the symptoms thereof; or

(ii) restoring, correcting or modifying any somatic or psychic or organic function; or

(iii) the diagnosis or prevention of pregnancy,

and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or 

on the human body but which may be assisted in its function by such means; or

(b) declared by the Minister by notice in the Gazette to be a medical device,

and includes any part or an accessory of a medical device; . . . . 

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classification system of medical devises and in vitro diagnostic medical devices (IVDs); 

classification of medical devices and IVDs would be determined by the Medicines Control 

Council (MCC).140 The regulations would require the registration of all medical devices (except 

custom-made devices) and IVDs with the MCC before they can be sold or used in South 

Africa.141 While the draft regulations do not appear to impose a specific time frame for the 

completion of a regular registration process, they would permit expedited registration of medical 

devices or IVDs if

• the medical devices or IVDs in question are in short supply or are unavailable;

• the Minister determines that expedited registration is in South Africa’s national interest; or

• the South African government makes an international tender for a medical device or IVD and 

such medical device or IVD is not already registered at the time of the tender.142

In these instances, the MCC is required to inform the applicant of its decision within nine months 

of the receipt of the application.143 

Spain

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (Spanish Agency on 

Drugs and Health Products) is responsible for ensuring the quality, safety, efficiency, and 

accuracy of information on drugs and medical devices in order to protect and promote health in 

both human beings and animals.144

The AEMPS is in charge of the evaluation and authorization of medicine and medical devices 

for human and animal use, to include the authorization of clinical trials and the monitoring of 

medical products safety once on the market and the inspection of laboratories.145

Medicines and Related Substances Act 101 of 1965, § 1, http://www.lawsofsouthafrica.up.ac.za/index.php/browse/ 

medical-and-health/medicines-and-related-substances-act-101-of-1965/act/101-of-1965-medicines-and-relatedsubstances-act-2-may-2003-to-date-pdf/download. 

140 Medicines and Related Substances Act, 1965 (Act No. 101 of 1965): General Regulations Relation to Medical 

Devices and In Vitro Diagnostic Medical Devices (IVDs), § 14, 586 GG No. 37579 (Apr. 22, 2014), available on the 

South African government website, at http://www.gov.za/documents/download.php?f=213278. The Medicines 

Control Council is a “statutory body that regulates the performance of clinical trials and registration of medicines 

and medical devices for use in specific diseases.” The Medicines Control Council, DEPARTMENT OF HEALTH,

http://www.sanctr.gov.za/YourRights/TheMedicinesControlCouncil/tabid/176/Default.aspx (last visited 

Sept. 8, 2014).

141 Id. § 8. 

142 Id. §§ 2 & 3. 

143 Id. 

144 Misión Y Visión de la Agencia Española de Medicamentos y Productos Sanitarios, AGENCIA ESPANOLA DE 

MEDICAMENTOS Y PRODUCTOS SANITARIOS (AEMPS) (Mar. 2009), http://www.aemps.gob.es/laAEMPS/ 

mision/home.htm.

145 Quienes Somos?, AEMPS (Mar. 2013), http://www.aemps.gob.es/laAEMPS/presentacion/ home.htm.

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Real Decreto 1591/2009146 por el que se Regulan los Productos Sanitarios (Royal Decree that 

Regulates Health Products) provides for the definition of “medical device” and the requirements 

that such a device must meet for its release to the public. According to this regulation, a medical 

device is a product used in health care services that is not medicine, for example, instruments to 

correct deficiencies such as glasses or hearing aids, diagnostic equipment, active and inactive 

implants, dental products, ophthalmic and optical products, electromedical and mechanical 

products, reusable instruments such as surgical instruments, and hospital equipment.147

The AEMPS is the authority within the Ministry of Health and Social Policy in charge of 

approving medical devices for general public use.148 The manufacturer of a medical device who 

intends to put one of these products into the Spanish market must file a petition before the 

AEMPS with documentation of its design, the manufacturing process, sterilization, operational 

tests, clinical trials, and any other relevant technical information.149 After the requirements are 

fulfilled, and if the result of the tests is favorable, the AEMPS issues a certificate of conformity 

that allows the product to be released for its use.150 In exceptional circumstances a physician 

may request the use of a medical device or product not previously authorized in Spain, either 

because there is no similar product already available in the market or because he or she considers 

the product in question to be a better alternative for a patient, considering other available 

options.151 In such a case, there is an expedited procedure for the release of medical devices to 

be used before final approval is completed.152 A special form to be filed with the AEMPS needs 

to be presented to petition for an expedited approval of a medical device under the strict 

supervision of the physician involved. The filing may be done online.153 

Switzerland

Unlike medicinal products, medical devices do not undergo an official authorization procedure in 

Switzerland. Rather, Switzerland has adopted the European Union (EU) system of compliance 

assessment and certification, based on bilateral agreements.154 Compliance with internationally 

146 Real Decreto 1591/2009 por el que se Regulan los Productos Sanitarios [Royal Decree that Regulates Health 

Products], BOLETÍN OFICIAL DEL ESTADO, Oct. 16, 2009, available at AEMPS, http://www.aemps.gob.es/ 

legislacion/espana/ productosSanitarios/docs/Directiva_93-42-CEE/rcl_2009_2105.pdf.

147 Id. art. 2.1.a. & 3.

148 Id. arts. 4–6.

149 Id., Anexo VII.

150 Id. art. 13.

151 Aplicación de Envíos Telemáticos:Autorización Expresa de Utilización de Productos Sanitarios [Online 

Application for Expedited Authorization of Medical Products] (Oct. 28, 2013), https://sede.aemps.gob.es/PSCH/ 

PS/autorizacionexpresa_ps.htm#documentacion.

152 Real Decreto 1591/2009, art. 15.

153 Instrucciones para la Solicitud de Autorizaciones Expresas de Importación y Utilización de Productos Sanitarios 

en Interés de la Salud Bajo Responsabilidad Médica [Instructions for the Application for Expedited Authorizations 

of Import and Use of Medical Products in the Interest of Public Health Under Physician Responsibility], AEMPS 

(Feb. 2011), http://www.aemps.gob.es/productosSanitarios/docs/instrucciones-solicitud-autorizacion.pdf. 

154 ABKOMMEN ZWISCHEN DER SCHWEIZERISCHEN EIDGENOSSENSCHAFT UND DER EUROPÄISCHEN GEMEINSCHAFT 

ÜBER DIE GEGENSEITIGE ANERKENNUNG VON KONFORMITÄTSBEWERTUNGEN [AGREEMENT ON MUTUAL 

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valid norms is evaluated by private entities. Medical devices are attributed to various categories 

that require varying assessment procedures.155 Devices are classified according to the risk they 

pose to the patient.156 Certain low-risk medical devices can be assessed by the manufacturing 

company itself.157 Devices with higher risks are to be certified by so-called “notified bodies,” 

private entities that are certified by the EU Member States.158 The time for issuing a certification 

by the Notified Bodies is variable.159 The Swiss Agency for Therapeutic Products (Swissmedic) 

can grant special permission for certain medical devices not fulfilling the qualifications. 

However, this special permission can only be issued to products for use by a single person.160

United Kingdom

Three European Directives govern how the UK regulates the approval process for medical 

devices.161 The Directives aim to harmonize the regulation of medical devices across the EU. 

The United Kingdom has given effect to these regulations through the Medical Devices 

Regulations 2002.162

The term “medical devices” in the UK covers a range of items, from wound dressings to artificial 

hips.163 Generally, a medical device requires a CE marking, which allows it to be marketed and 

RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT BETWEEN THE EUROPEAN COMMUNITY AND THE SWISS 

CONFEDERATION] OF JUNE 21, 1999, as amended through Dec. 17, 2012, SYSTEMATISCHE RECHTSSAMMLUNG [SR]

[CLASSIFIED COMPILATION] 0.946.526.81, Annex 1, ch. 4.

155 Medical Devices, SWISSMEDIC, https://www.swissmedic.ch/medizinprodukte/01175/index.html?lang=en (last 

visited Sept. 5, 2014).

156 See, e.g., Directive 93/42/EEC, supra note 3, Annex IX.

157 Id., Annex VII.

158 See, e.g., id. art. 16.

159 AOK-BUNDESVERBAND, supra note 82, at 7.

160 Medical Devices Ordinance [MepV] of Oct. 17, 2001, as amended through Apr. 1, 2010, SR 812.213, art. 9(4), 

https://www.swissmedic.ch/ueber/00134/00493/00500/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU04

2l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCDdIB2gWym162epYbg2c_JjKbNoKSn6A--.

161 Directive 93/42/EEC, supra note 3; Directive 90/385/EEC, supra note 2; and Directive 98/79/EC, supra note 4.

162 These regulations are issued under the Consumer Protection Act 1987, c. 43, http://www.legislation.gov.uk/ 

ukpga/1987/43. 

163 A “medical device” is defined in the regulations as 

. . . an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together 

with any software necessary for its proper application, which—

(a) is intended by the manufacturer to be used for human beings for the purpose of-

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease, 

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, 

(iii) investigation, replacement or modification of the anatomy or of a physiological process, or 

(iv) control of conception; and 

(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or 

metabolic means, even if it is assisted in its function by such means, and includes devices intended to administer a 

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sold across the EU.164 This mark shows that the device meets regulatory requirements, works as 

intended when used, and has an acceptable safety level that complies with the Essential 

Requirements of the EU Directives.165

The Medicines and Healthcare Products Regulatory Agency (MHRA) regulates medical devices 

across the UK. Before medical devices can be marketed and used in the UK, they must be 

approved by private-sector organizations known as “notified bodies.”166 These bodies conduct a 

conformity assessment procedure in order to approve products, and devices will only receive the 

CE mark if the evidence shows that the potential benefits of the device outweigh the 

likely risks.167

Devices are classified into four groups, and each group has different criteria that must be met in 

order to receive a CE mark.168 Low-risk device (class I) manufacturers may register with the 

MHRA and make a declaration that the product meets the statutory requirements to receive the 

CE mark.169 Medium-risk (classes IIa and IIb) and high-risk (class III) devices (which include, 

for example, in vitro devices, active implantable devices, and sterile devices used for measuring) 

must meet more stringent criteria.170 Obtaining a CE mark for medium-risk devices involves a 

declaration by the manufacturer that the product conforms with the provisions of the Medical 

Devices Regulations and the relevant essential requirements. This must then be verified by an 

assessment by the notified body, which can be one of the following selected by the manufacturer: 

an examination and testing of each product or a batch of products; an audit of the product quality 

assurance system; an audit of final inspection and testing; or an audit of the complete quality 

medicinal product or which incorporate as an integral part a substance which, if used separately, would be a 

medicinal product and which is liable to act upon the body with action ancillary to that of the device . . . . 

Medical Devices Regulations 2002, SI 2002/618 ¶ 2, http://www.legislation.gov.uk/uksi/2002/618/regulation/ 

2/made.

164 MHRA, MEDICINES & MEDICAL DEVICES REGULATION: WHAT YOU NEED TO KNOW ¶ 7 (2012), 

http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con2031677.pdf. 

165 What Kinds of Decisions Are Made About Medicines and Medical Devices?, MHRA, 

http://www.mhra.gov.uk/Howweregulate/Whatkindsofdecisionsaremadeaboutmedicinesandmedicaldevices/index.ht

m (last visited Sept. 9, 2014).

166 Notified bodies are independent certified bodies responsible for verifying that devices work effectively and as 

intended in an acceptable safe manner. The MHRA appoints and audits these bodies to ensure they perform to high 

standards. MHRA, MEDICINES & MEDICAL DEVICES REGULATION, supra note 152.

167 What Kinds of Decisions Are Made About Medicines And Medical Devices?, supra note 153.

168 The classes are class I (low risk), class IIa and IIb (medium risk), and class III (high risk). Classification of the 

device involves assessing a number of factors, including whether the device is intended to be used continuously, is 

invasive, or is implantable or active. The purpose of the device, as stated by the manufacturer, determines the class 

in which the device is placed. Medical Devices Classification, MHRA, http://www.mhra.gov.uk/Howweregulate/ 

Devices/Classification/index.htm (last visited Sept. 9, 2014).

169 Who Makes the Decisions, MHRA, http://www.mhra.gov.uk/Howweregulate/Whomakesthedecisions/index.htm

(last visited Sept. 9, 2014).

170 Id. 

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assurance system.171 High-risk devices generally require clinical trials to demonstrate their

safety.172 In order to conduct a trial in the UK, the MHRA agree to such trials. The MHRA 

generally approves four out of five of these types of applications, and the refusals are on the 

ground of patient safety or health policy restrictions.173 There does not appear to be a process to 

expedite the conformity assessment procedure. 

171 Conformity Assessment and the CE Mark, MHRA, http://www.mhra.gov.uk/Howweregulate/Devices/Complying 

withlegislation/ActiveImplantableMedicalDevicesDirective/ConformityassessmentandtheCEmark/index.htm (last 

visited Sept. 9, 2014). 

172 Id. A flow chart of the procedure for the different classifications of devices is available at Class I Medical 

Devices – Routes to CE Marking, MHRA, http://www.mhra.gov.uk/home/groups/dts-bs/documents/website 

resources/con286776.pdf (last visited Sept. 9, 2014). 

173 MHRA, MEDICINES & MEDICAL DEVICES REGULATION, supra note 152, ¶ 9. 

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RU

CA

CN

BR

AU

MX

ZA

FR

Legend

Legislation Proposed

Expedited Process - Temp Approval

Expedited Process in Place

Expedited Process Cancelled

Other Countries in Study

FR

ES

DE

GB

CH

NL

IL

Expedited Process for Approval of Medical Devices

JP