Promotion Code of the Medical Device
Industry

Revised on March 10, 2021

Japan Federation of Medical Devices Associations

<Revision History of the Promotion Code of the Medical Device Industry>
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Established on January 28, 1997, implemented on February 20, 1997
Revised on June 22, 2000, implemented on July 1, 2000
Revised on July 29, 2003, implemented on October 1, 2003
Revised on March 25, 2005, implemented on April 1, 2005
Revised on June 30, 2010, implemented on October 1, 2010
Revised on November 1, 2015, implemented on November 1, 2015
Revised on March 10, 2021, implemented on April 1, 2021

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Promotion Code of the Medical Device Industry

1.

Objective, Scope, etc.

1-1

Objective

The objective of the Promotion Code of Medical Device Industry (hereinafter, “this Code"), which sets forth thecode of conduct to be observed by Member Companies of the Japan Federation of Medical Devices Associations(hereafter, "the JFMDA") in their promotional activities for medical devices, is to maintain and improve the publictrust in the medical device industry through conducting transparent corporate activities of all Member Companies
rooted in compliance with a high ethical view while giving the highest priority to their contribution to the health andwelfare of patients as members of the life science industry.
1-2

Scope

This Code applies not only to the promotional activities for medical devices but also to all relationships(transactions, information provision, interactions, etc.) between Member Companies and medical institutions,healthcare professionals, and researchers, etc.
Member Companies shall create internal regulations targeting all the officers and employees based on this Codeand comply with this Code. In addition, Member Companies shall always make judgment based on whether theiractions are in accordance with the purport of this Code regardless of the presence or absence of specific descriptionsin this Code.
1-3

Definition of promotion

In this Code, "promotion" refers not only to so-called sales promotion but also to the provision, collection, andcommunication of information on medical devices to medical institutions, healthcare professionals, etc. to ensure
proper and safe use of medical devices.
2.

Responsibilities of Member Companies
The basic philosophy of corporate activities of Member Companies is to strongly recognize their social mission

as life science companies, share their values with the society, propose new values through their corporate activities,
and contribute to the realization of healthy and happy lives of people.
Member Companies shall establish an internal system for proper promotion based on this basic philosophy, beaware that they are fully responsible for the promotional activities conducted by their employees, and implement thefollowing:(1) To conduct highly transparent corporate activities by taking the utmost care to ensure the efficacy and safetyof products and securing fair and free competitions.
(2) To accurately provide the latest data in an appropriate manner based on clear scientific evidence whenproviding information on medical devices to medical institutions, etc.
(3) To provide continuous education and training to the officers, employees, etc. to implement proper promotion.
(4) To establish an internal system to comply with the relevant laws and regulations and the voluntary code of
conduct.

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3.

Responsibilities of High-level Management
The high-level management of Member Companies performs the following matters with a high level of ethicalview and strong sense of responsibility to meet social expectations and trust as a life science company.
(1) To take initiative in complying with this Code, consider the actions of all the officers, employees, etc. as the
responsibility of the top management, thoroughly inform the concerned parties, and improve the internal system.
(2) In case of any event that is likely to be against the spirit of this Code, to address the problem-solving at its own
responsibility and do its best for prompt diagnosis and the prevention of recurrence.
(3) The divisions in charge of products other than medical devices shall also make efforts to conduct corporate
activities while respecting the spirit of this Code.
(4) To make efforts to ensure the subsidiaries that manufacture and sell medical devices in Japan also comply withthis Code.
(5) To express its stance to comply with this Code to affiliated companies and business partners who manufactureand sell medical devices in or outside Japan and strive to ask for their understanding.
4.

Relationship with Medical Institutions/Healthcare Professionals
The relationship between Member Companies and medical institutions/healthcare professionals shall aim tocontribute to the advancement of life science such as medical science and medical engineering and the improvementof public health and shall focus on the provision of information on medical devices, the academic exchanges on
medical science and healthcare, and the research support. Even when promoting industry-academia collaboration,
Member Companies shall also establish relationships of trust with researchers and healthcare professionals for thedevelopment of medical devices and advancement of medical science and healthcare.
When interacting with medical institutions/healthcare professionals, Member Companies shall comply with the"Fair Competition Code of the Medical Devices Industry" (hereafter, "FCC") and shall not conduct corporate
activities which are likely to inappropriately influence their decisions to use or select medical device products.
4-1

Written agreement

Upon not only outsourcing operations such as research, survey or lectures to medical institutions/healthcare
professionals but also having transactions with Customers, Member Companies must dispel the ambiguity of theterms of trade by exchanging documents such as written contracts and conduct corporate activities by safe andsmooth methods with the high level of transparency.
For the transactions with the public offices, Member Companies must observe the related legislation and deal withthe business according to the regulations set forth by the public offices, if any.
4-2

Outsourcing

Member Companies may outsource operations such as research, clinical studies, post-marketing surveillances,consultations/technical guidance, participation in meetings, writing/supervising articles, acting as chairpersons or
speakers at lecture meetings, and giving training instructions to medical institutions/healthcare professionals and pay
remunerations/expenses based on legitimate needs. When outsourcing these operations, however, a contract must be
singed and meet all of the following criteria;(1) A written contract specifying the purpose of the operation and the remunerations/expenses for the operation
should be signed.
(2) The legitimate need for the operation should be clearly identified before outsourcing.
(3) The contractor of the operation should have its specialty directly related to the identified need and reasonable2reasons to be selected, like based on its expertise needed for the operation.
(4) The number of contractors of the operation should be reasonable to achieve the identified need.
(5) It should not be intended to inappropriately induce to use, select, prescribe, purchase and/or recommend
medical device products or accept contract offer for medical device control operations (hereafter, collectively,"Adoption of medical devices") should not be wrongly induced.
(6) The remuneration for the operations should be appropriate as a consideration for the outsourced operations.
4-3

Offering of cash or cash equivalents, goods, and services(1) Member Companies shall not offer, directly or indirectly, cash or cash equivalents, goods or services, which
are likely to have an influence on the Adoption of medical devices, to medical institutions/healthcare
professionals.
(2) Member Companies may provide cash or cash equivalents, goods or services to an appropriate extent in lightof normal business practices in accordance with the related laws and regulations and the FCC with respect toacademic research, education, and activities to improve public health conducted by medical
institutions/healthcare professionals.
4-4

Securing transparency

Member Companies are required to have a high ethical view as life science companies and need to appropriately
fulfill the accountability to the society concerning their ethical and sincere relationships with medical
institutions/healthcare professionals and researchers. Member Companies must ensure the transparency of corporate
activities under the "Transparency Guidelines for the Medical Device Industry and Its Relationships with Medical
Institutions and Other Organizations" of the JFMDA and their own guidelines developed based on the Transparency
Guidelines.
In addition, the guidelines for the management of conflict of interest (COI) established by medical institutions andother organizations such as academic societies must be understood and respected.
4-5

Relationship with Officials

When entrusting operations or providing cash or cash equivalents, goods or food/drink to national, local
governments or deemed civil service officials (hereafter, "Officials "), Member Companies must understand andrespect the National Public Service Ethics Act, the related laws and regulations such as the National Public Service
Ethics Code, and the in-hospital ethics code established by public medical institutions.
5.

Environmental Conservation
In all their corporate activities including development, manufacturing, and sales of medical devices, Member

Companies shall comply with the environment-related laws and regulations and proactively work on environmental
preservation as well as resource protection.
6.

Protection of Information

6-1

Protection of confidential information

Member Companies must not obtain confidential information from customers, business partners or other third
parties (hereafter, "Customers") in an unfair manner. Member Companies must manage and handle confidential
information obtained from Customers in an appropriate and safe manner.

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6-2

Protection of personal information

Member Companies must manage and handle the personal information of patients, examinees of clinical study orcontract research, Customers, and business partners obtained through their business in an appropriate and safemanner in accordance with “the Act on the Protection of Personal Information” (Personal Information Protection
Act).
7.

Research and Development

7-1

Bioethics

Member Companies must give full consideration to bioethics in their activities such as development of medical
devices.
7-2

Clinical research

When conducting clinical or other type of research, Member Companies shall comply with the "Clinical Research
Act", the "Ethical Guidelines for Medical and Health Research Involving Human Subjects", and other related laws,
regulations, and guidelines.
7-3

Clinical study (clinical trial)

Studies and research activities such as clinical studies (clinical trials and post-marketing clinical studies) musthave highly ethical and legitimate scientific objectives in compliance with the laws and regulations and the ethicalguidelines provided by the government for each stage.
7-4

Animal welfare

Member Companies must promote further improvement of the research and development system for laboratory
animals necessary for the development of safer and more effective medical devices by ensuring appropriate voluntary
management from the viewpoint of animal welfare.
8.

Manufacturing/Marketing

8-1

Compliance with the relevant laws and regulations

For manufacturing/marketing of medical devices, Member Companies must observe the related legislation andgive full consideration to the efficacy and safety.
8-2

Stable supply

Member Companies must make efforts to ensure stable supply of medical devices approved (certified, notified)
for marketing.
8-3

Quality control

The marketing authorization holder must identify opportunities for improvement and refinement of medical
devices based on the information from the market through operations such as manufacturing control, quality control,
and post-marketing safety management and make efforts to improve and refine the medical devices from thestandpoint of users while ensuring quality.
9.

Market Research

4For the market research, Member Companies must observe the related legislation, etc. and not conduct, directly
or indirectly, any activities using the unfair means.
10. Post-marketing Surveillance
The objective of post-marketing surveillance, which is establishment of a proper use method of medical device
after marketing, must be accurately recognized. The surveillance must be conducted in accordance with the scientificvalidity and in compliance with the related laws and regulations and the self-regulations and must not be conducted
for the purpose of sales promotion.
11. Handling of Reportable safety information (adverse events and malfunctions, etc.)
If any information on adverse events, malfunctions, infections or research reports related to a medical device
manufactured and marketed by a Member Company or the regulatory measures such as discontinuation of
manufacturing, recall, and disposal in foreign countries (hereafter, collectively, "Reportable safety information") is
obtained, the company must promptly take actions.
The Reportable safety information obtained from medical institutions, etc. must be promptly reported to thePharmaceuticals and Medical Devices Agency (PMDA) based on the "Act on Securing Quality, Efficacy and Safetyof Pharmaceuticals and Medical Devices, etc." (hereafter, "PMD Act").
12. Preparation and Use of Promotional Materials
Promotional materials prepared by Member Companies or prepared by third parties with involvement of Member
Companies must be recognized as important means to provide information on medical science, healthcare, andmedical devices. When preparing and using promotional materials, ensure the contents are accurate, fair, andobjective based on scientific grounds in accordance with the PMD Act, the Standard for Adequate Advertisement ofPharmaceutical Products, etc. and related voluntarily established standards.
(1) In promotional materials developed by Member Companies, the brand name, the regulation classification, thegeneral name, and the handling of reimbursement of medical insurance shall be specified. In addition, thecontact point to request materials of such product must be clearly stated so that the request of materials fromoutside can be responded.
(2) The description and phrasing of efficacy and performance or purpose of use must not deviate from the scopeof marketing approval, certificate or notification.
(3) Do not use the maximum expression, false or exaggerated expressions or possibly misleading indications,layout or expressions for the quality, efficacy or safety. Description of safety as one of the characteristics, suchas "the occurrence of adverse events or malfunctions are rare", should not be used without a defined conditionand should be accompanied by a supplementary note of abstract that forms the grounds.
(4) Fairly note information on safety such as adverse events and malfunctions, etc. and do not incline toward
efficacy.
(5) Do not take up exceptional data and give an impression as if it is a general fact in their expression.
(6) Do not have the description or expression that slanders other companies and products of other companies.
(7) The comparison with other products should be conducted based on objective data by using general namewithout using any proper noun in principle.
(8) Do not use misleading expressions or expressions, pictures or illustrations that injure the manufacturer’s dignity.
5(9) The internal screening system for Promotional materials must be established by the Member Companies andPromotional materials must be used after passing its screening system.
13. Corporate Information Dissemination Activities
Member Companies must comply with the legal regulations and the voluntary code of conduct by reviewing thecontents starting in the planning stage even in activities to disseminate information such as press release, introductionof corporate activities such as company’s prospectus, provision of disease information to the public or patients, andinformation provision to investors so that the activities will not be suspected to be advertising activities for medical
devices or advertising to recommend unapproved medical devices or off-label use.
14. Information Provision and Sales Activities
Member Companies shall proactively and strictly comply with the Antimonopoly Act, the related laws andregulations such as the PMD Act, and the FCC in the information provision and sales activities for their medical
devices. Any divisions may take these regulatory actions whether it is a sales division or not.
Member Companies shall establish an internal management system to ensure fair and free competitions. The
JFMDA and its member associations shall also establish each committee, etc. to raise awareness and provide
guidance.
14-1

Holding and supporting lecture meetings and briefings

Member Companies may hold or support lecture meetings, workshops, product briefings, and proper use training
sessions for the purpose of providing specialized, academic, and scientific information on medical science andhealthcare and medical devices and information for disease awareness.
Appropriate places/venues must be selected for these meetings. Remunerations, travel expenses (transportation,accommodation, etc.), food/drink must be provided to persons involved in lecture meetings by complying with the
FCC and the related laws and regulations.
14-2

Offering of medical device samples

Medical device samples are means of providing information on the company’s medical devices to medical
institutions/healthcare professionals and to be used as an aid to confirm and evaluate the appearance features or
quality, efficacy and safety, etc. Medical device samples shall be provided with relevant information, which must be
kept to the minimum.
14-3

Medical equipment loan

Member Companies may “loan out” their medical devices to medical institutions/healthcare professionals for the
purpose of checking the appearance and the basic performance, clinical research to evaluate the product efficacy andsafety or contract/joint research on their medical devices.
In medical equipment loan to medical institutions and other organizations, Member Companies must confirm the
purpose, grounds, the minimum number/period of cases, etc. by written documents in advance.
14-4

On-site service for medical device operation

Member Companies may provide the minimum necessary "on-site service" to medical institutions/healthcare
professionals to ensure proper and safe use of their medical devices.
When the on-site service is provided to the medical institution free of charge, the frequency and duration must be
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determined in compliance with the FCC, and the service must be reviewed based on a document of the details of theservice provided. Member Companies must not conduct any acts that conflict with the relevant laws and regulationsin the course of on-site service.
14-5

Offering of articles

Articles Member Companies may offer to medical institutions/healthcare professionals must be those which arein conformity with legislation, regulations, etc., not likely to pose a risk to have an influence on the adoption orappropriate use of medical devices and accepted in light of normal business practice.
14-6

Offering of services

Member Companies shall not offer benefit, labor or other services, which is likely to be in conflict with the related
legislation and the FCC, for free to medical institutions/healthcare professionals without rationale.
15. Unapproved Medical Devices
15-1

Provision of information on unapproved medical devices

Member Companies may not provide information on unapproved medical devices for the purpose of sales
promotion without request from doctors, etc. However, the information may be provided upon request from doctors,
etc. if evidence is available in scientific and technical sentences describing the medical device, such as publicly
known literature and papers, and within the range of academic research reports.
In lecturers on unapproved medical devices given by doctors at joint seminars hosted by academic societies andMember Companies, the slides and the abstracts must state unapproved contents are included.
15-2

Exhibition of unapproved medical devices

Exhibition of unapproved medical devices shall be permitted only if it is requested and approved by the exhibition
manager of the exhibition.
15-3

Provision of unapproved medical devices

When providing unapproved medical devices to medical institutions for clinical use, comply with the related laws
and regulations such as the Clinical Research Act.
16. Promotion Outside Japan (Provision of Medical Devices Information Outside Japan)
With regard to medical devices information given to healthcare professionals outside Japan, regardless of directly
or indirectly, Member Companies will provide according to legal restrictions or industrial voluntary codes of therelevant country.
17. Administration and Revision/Abolition of This Code(1) The administration of this Code will be conducted by Business Ethics Committee established in the JFMDA.
Necessary matters regarding the organization, structure and operation of Business Ethics Committee will be
determined separately.
(2) The Business Ethics Committee shall, when a complaint is filed for a case suspected to violate this Code orwhen it is deemed necessary based on a voluntary decision, deliberate and investigate the complaint. Member
Companies shall assist with the investigation conducted by the Business Ethics Committee.
7(3) Regarding the preceding paragraph, the Business Ethics Committee may conduct activities to raise awarenessamong Member Companies and take other measures to prevent recurrence if any act violating this Code isrecognized. Matters necessary for responding to complaints shall be separately stipulated.
(4) The Business Ethics Committee shall review this Code as necessary to ensure its effectiveness.
(5) To revise or abolish this Code, an approval of the JFMDA board of directors must be obtained.

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