Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
 
Regulations for the Registration, Classification, Importation and Inspection of 
Biomedical Equipment and Material  
No -S 
THE PRESIDENT OF THE REPUBLIC  
AND THE MINISTER OF HEALTH  
Availing of the powers conferred on them by Article 140.3 and 140.18 and by Ar ticle 146 of the 
Constitution of Costa Rica; by Article 27.1 of the General Public Administration Law; and by Articles 1, 2, 
4, 7, 49, 142, 143, 144 and 145 of Law No 5395 of 30 October 1973, “General Law on Health”.  
Whereas:  
I. At the moment health is re garded as the result of a process in which the State makes efforts and takes 
steps to ensure the general well -being.  
II. Biomedical equipment and material are very important for the detection and treatment of diseases, and 
their proper functioning is vital  to obtain the expected results with a view to promoting general health.  
III. With the social production of health, each party must assume its responsibilities. In this case, the 
manufacturer or seller is responsible for guaranteeing to the user that biom edical equipment and material 
has been designed for the purpose established, while the user must guarantee its proper functioning 
during its useful life, and the Government is responsible for verifying that the products comply with the 
laws in force.  
IV. The steps taken to guarantee the safety of BEM would be pointless if they were not based on 
systematic efforts and on requirements established according to the most modern, efficient controls.  
 
V. The measures designed to guarantee the quality and safety of BEM must be adopted without affecting 
the free movement of goods and product supplies at national level.  
 
VI. The Law on the Protection of Citizens from Excess Requirements and Administrative Procedures and 
the law to Promote Competition and Efficient Consumer Protection seek to guide the action of the Public 
Administration in line with the basic principles of rationality, uniformity, publicity, promptness and precision 
in order to deal with proceedings involving citizens. This forces the State to revis e, analyse and eliminate 
unnecessary procedures and requirements that block or impede the enjoyment of fundamental rights. 
Given this, only those procedures or requirements that, in the public interest, cannot be replaced must be 
regulated in order to achi eve the public purpose in question without blocking technological progress.  
VII. Registration of such products is a means of inspection and organisation of their importation and use by 
the persons authorised for this purpose.  
VIII—This Regulation permits the effective inspection of BEM and of their operation, importation and 
commercial use by registered undertakings or persons, in line with fundamental human rights and the 
need to guarantee human health protection. Therefore , 
The following  
IS DECREED:  
 
Regulation for the Registration, Classification,  
Importation and Inspection of Biomedical Equipment and Material  
  
CHAPTER I  
Scope and definitions  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
Article 1. The purpose of this Regulation is to establish the requirements and procedures necessary for 
the clas sification, registration, importation and inspection of biomedical equipment and material, hereafter 
referred to as BEM, intended for human use.  
Article 2. The provisions in this Regulation shall apply to all acts of classification, importation, registrati on 
and inspection of biomedical equipment and material sold on the territory of Costa Rica.  
Article 3. For the purposes of this Regulation, the following definitions are established:  
3.1.  Accessory : a product exclusively designed to be incorporated into or to complement medical 
equipment, with a complementary technical function or characteristic.  
3.2.  Good manufacturing practices : the set of standards and procedures designed to guarantee 
uniform production of BEM batches as well as their safety and effi ciency, in line with national and 
international quality standards.  
3.3.   Model approval certificate: the document issued by the Costa Rica Laboratory of Metrology 
(LACOMET) which certifies that the BEM model complies with the metrological requirements la id 
down in technical regulations currently applicable.  
3.4.     Certificate of free sale : the document issued by the health authority which certifies that the product 
referred to in the certificate is authorised for sale, use and distribution in the countr y or region of 
origin. This certificate may cover one or more products; it shall not be older than two years from 
the date of issue. In the event that the product was manufactured by a third party, the certificate 
may be issued by the health authority of t he country where the product was manufactured. The 
product code to be registered must be clearly identifiable on the Certificate of Free Sale.  
3.5.   State inspection : the procedure carried out by the State to verify and check compliance with the 
regulati ons in force.  
3.6.    Directorate: Directorate of Registration and Inspection of the Ministry of Health.  
3.7.    Biomedical equipment and material (BME ): any instrument, device, equipment, material or other 
article used alone or in conjunction with other s, including computer programs required for their 
proper functioning, designed by the manufacturer for use on human beings, for any one of the 
following purposes: diagnosis, prevention, verification, treatment of or relief from an illness; 
diagnosis, contr ol, treatment of, relief from or compensation for an injury or disability: research, 
replacement or modification of the anatomy or of a physiological process; regulation of conception, 
providing that the product does not exercise its main action by pharmac ological, immunological or 
metabolical means, although it may contribute to such means.  
3.8.    Active medical equipment : any BEM whose functioning depends on the electricity supply or on 
any other source of power other than that generated by the human bod y or gravity, and which 
functions by converting this energy. Medical equipment designed to transmit energy, substances or 
other elements from active medical equipment to the patient without causing any significant 
alteration is not regarded as active medic al equipment.  
3.9.    Active medical equipment for diagnosis : any active BEM used alone or in combination with other 
medical equipment, designed to provide information for the detection, diagnosis, monitoring or 
treatment of physiological conditions or he alth, diseases or congenital deformities.  
3.10.   Active medical equipment for therapy : any BEM used alone or in combination with other medical 
equipment, designed to maintain, modify, replace or restore biological functions or structures in the 
context of  the treatment or relief of a disease, injury or disability.  
3.11.   Disposable active medical equipment : any BEM designed to be used for prevention, diagnosis, 
therapy, rehabilitation or contraception, to be used only once according to the manufacturer’s 
specifications.  
3.12.  Implantable medical equipment:  any BEM designed to be implanted fully or partly in the human 
body or to replace an epithelial area or ocular area by means of surgery.  
3.13.   Invasive medical equipment : medical equipment which is in contact with the surface of the eye or 
which penetrates the human body fully or partly, either through a bodily orifice or through part of the 
body surface.  
3.14.  Surgically invasive medical equipment : invasive medical equipment which penetrates inside t he 
human body by means of an opening created artificially which permits access to bodily fluids and Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
organs. The artificially -created opening can be big due to a surgical incision or small, such as that 
caused by a needle.  
3.15.   Equipment with self -control  systems : equipment which has systems that permit the BEM to 
perceive, interpret or treat a patient’s medical condition by themselves.  
3.16.  “In vitro” equipment for diagnosis : any BEM and its reagents, gauges, controls and 
consumables, which are designed  to examine or diagnose samples or fluids taken from the human 
body.  
3.17.   “In vitro” equipment for diagnosis for personal use : equipment for “in vitro” diagnosis designed 
to be used outside the clinical laboratory for a specific test which should be car ried out and 
interpreted under the entire responsibility of the patient.  
3.18. Reconstructed equipment:  used equipment which has been repaired using parts not provided by 
the manufacturer.  
 
3.19. Re -manufactured equipment : used equipment which has been re paired in the factory and whose 
parts are original.  
 
3.20.  Used equipment:  equipment which is neither new nor reconstructed nor re -manufactured.  
3.21.  Clinical examination : examination involving one or more human subjects which produces clinical 
data fo r use in demonstrating the safety and efficiency of BEM.  
3.22.   Medical and technical specifications : the specifications of technical and medical parameters, 
including permissible variations, general description and blocks made up of the equipment and 
model as well as quality and reliability specifications.  
3.23.   Quality standards : minimum acceptable requirements with which BEM must comply in order to 
guarantee its safety and efficiency.  
3.24.   Label:  any sticker, image, signplate or other descriptive o r graphic material which has been written, 
printed, stencilled, printed in relief, stuck on or inserted into the BEM, and which identifies and 
describes it.  
3.25.  Labelling : any written, printed or graphic material which the label contains, which accompa nies the 
BEM, including that designed to promote its sale or placement.  
3.26.   Risk analysis : formal scientific process to gather and interpret scientific information from many 
sources in order to analyse and describe the risk.  
3.27.       Accuracy : degre e of proximity of a result or of the average of a set of results to the real value.  
3.28.   Manufacturer : any natural or legal person who manufacturers, assembles or processes BEM for       
sale as a finished product, including third parties authorised by the manufacturer to sterilise, label or 
package the equipment.  
3.29.   BEM family : set of BEM equipment which has been produced by the same manufacturer, has the 
same design and manufacturing process, will be used for the same purpose, and which differs on ly in 
shape, colour, taste or size.  
3.30.  Family of BEM groups : a set of BEM groups which are produced by the same manufacturer, have 
the same generic name and specific use, and which differ only in the number and combination of 
products contained in eac h group.  
3.31.  Family of test kits:  a collection of test kits which are produced by the same manufacturer, have the 
same initial generic name and specific use, and which belong to the same group within a diagnostic 
area or sub -area. 
3.32.   BEM group:  cons ists of a set of BEM equipment presented for sale jointly for use in a specific 
procedure. The components may vary and may be produced by different manufacturers.  
3.33. Importer : natural or legal person who performs the activity of bringing into the countr y BEM 
manufactured outside the country, and who must be duly registered with the Ministry of Health. All 
importers not registered shall be legally responsible for compliance with the provisions in this 
Regulation.  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
3.34.  Instructions for use : written or ele ctronic documents such as manuals, prospectuses, guides, inserts 
and other documents accompanying the BEM and containing technical information on it.  
3.35.  Reusable surgical or dental instrument : instrument designed for surgical use for cutting, sawing, 
levelling, clamping, scraping, removing, gripping or carrying out any other similar procedure without 
being connected to an active BEM, which may be used again once the procedures are completed.    
3.36.   Clinical research : research using human beings desig ned to check the performance, safety and 
efficiency of BEM in accordance with the laws in force in Costa Rica in this domain.  
3.37.   Testing kit : consists of reagents or articles, or a combination of them which are used together to carry 
out a specific te st. It does not include the necessary instruments to carry out the test. The 
components of a kit must be registered on the same register although they can be sold separately to 
replace the items in the kit.  
3.38.   Batch or lot : amount of a product produce d during a manufacturing or sterilisation cycle, whose 
essential characteristic is homogeneity.  
3.39.   Poor functioning : alteration of functioning which modifies the performance of the BEM, preventing 
the expected effect.  
3.40.   Dental material : all BEM items designed to be inserted into the pulp cavity of dental articles or to 
adhere only to the enamel or dentine of the parts.  
3.42.  Notification : act by which the document required under this Regulation is produced and supplied to 
enable BEM to be import ed, manufactured, handled and marketed in Costa Rica.  
3.43.  Bodily orifice : any natural opening in the human body, including the ocular cavity, or any 
permanent opening artificially created, such as a stoma.  
3.44.  Country of origin: country in which the  BEM manufacturing process is carried out . 
3.45.  Operating permit:  the public document issued by the Ministry of Health which grants authorisation 
for operation or functioning to an establishment which manufactures or imports BEM, following 
compliance wit h the health conditions laid down by law and the corresponding regulations.  
3.46.  Precision:  degree of concordance between the results obtained in an analytic determination, with 
an experimental procedure being used several times, under the prescribed con ditions, to ensure 
that it can be repeated and reproduced.  
3.47. Monitoring programme:  standardised procedure for post -manufacture monitoring by which 
information is gathered periodically on any defects in BEM, deterioration in its performance, any 
problem s regarding labelling or the instructions for use, or any factor that could cause the death of 
or serious damage to the health of the patient, user or another person.  
3.48.  BEM Health Registration:  a process by which the Ministry of Health approves the us e of a product 
after having assessed the scientific information demonstrating that the product is suited to the 
proposed objectives and is not dangerous to human health.  
3.49.  Risk:  probability of causing unexpected damage to the health of patients. This risk includes the 
degree of invasibility, the contact time, the effect on the patient’s physical system and local effects 
versus systemic effects.  
3.50.  System:   BEM included in the BEM for “in vitro” diagnosis which is sold under the same name and 
contai ns a number of components designed to be used together to fulfil all or part of the function for 
which the equipment was created. Components that are not sold under the system name cannot be 
registered with the system even if they were designed to be used together. All the system 
components produced by the same manufacturer shall be registered together, while components 
made by other manufacturers shall be registered separately. The reagents and consumables 
registered as part of the system may be sold separ ately as replacements for the system.  
3.51:   Registration manager: natural or legal person who manages the health registration of a particular 
item of BEM and who is legally responsible for any failure to comply with the national laws.  
3.52.  Product owne r: natural or legal person who owns BEM which is sold under a specific name or trade 
mark.  
 
 
CHAPTER II  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
Classification of BEM  
Article 4. For the purpose of registration and inspection, BEM is classified according to risk, therefore the 
risk classification recommended by the Pan American Health Organisation (PAHO) for Latin America is 
the basis for the classification, which is in line with the global harmonisation process.  
This classification groups together the various types of BEM according to the risk to  which the patient or 
operator may be exposed. In classifying BEM, the potential risk areas taken into account include the 
degree of invasibility, the contact time between the BEM and the body, the body system affected and 
whether there are systemic or loc al effects. Invasive BEM is usually regarded as being of higher risk than 
its non -invasive equivalent (eg. there are invasive and non -invasive blood pressure monitors). Similarly, 
BEM which has a prolonged contact time, concerns vital organs such as the he art or main arteries, or has 
systemic effects is classified in high -risk categories.  
Depending on its risk, the BEM is classified in four categories or classes, thus those with the lowest risk 
are in class 1, and those with the highest risk are in class 4.  Where BEM can be classified in more than 
one category, it is placed in the highest risk category.  
Where BEM for in vitro diagnosis, including analysers, reagents and software, is used with other BEM for 
in vitro diagnosis, both types of BEM are classifie d in the high -risk category.  
BEM whose features are not described in this classification is placed in a class decided on by the Ministry 
by means of an administrative decision, which must be incorporated into the Regulation.  
4.1. BEM Class 1  
4.1.1. Non -invasive BEM which is placed in contact with the damaged skin or mucous and is 
used as a mechanical barrier for the compression or absorption of exudate.  
4.1.2. Non -surgical, invasive BEM, not connected with active medical equipment, which is used 
for up to 60 minutes continuously.  
4.1.3. Invasive BME which penetrates the body via the oral or nasal cavity to the pharynx or via 
the external auditory conduct to the eardrum.  
4.1.4. All re -usable surgical and dental instruments.  
4.1.5. BEM for in vitro diagnosis  which is not included in classes 2, 3 or 4.  
4.1.6. All BEM which is not included in classes 2, 3 or 4.  
4.1.7 BEM, with the exception of BEM for in vitro diagnosis, whose manufacture fully or partly 
includes tissue of animal origin or its derivatives, viab le or not, as well as products obtained by 
using recombinant DNA technology used for contact only with intact skin.  
4.1.8. Microbiological mediums and BEM for in vitro diagnosis used to identify or infer the identity 
of a micro -organism.  
4.2. BEM Class 2  
4.2.1. Invasive BEM which penetrates the body via a bodily orifice or which is in contact with the 
surface of the eye.  
4.2.2. All latex condoms.  
4.2.3. Non -invasive BEM used to store or channel gases, liquids, tissue or bodily fluids with a 
view to introdu cing them into the body through an infusion or by other means.  
4.2.4. All non -invasive BEM which has been designed to be in contact with damaged skin, 
excluding that used as a mechanical barrier for the compression or absorption of exudate.  
4.2.5. Non -invasive BEM designed to modify, through centrifugal action, gravity filtration or 
exchange of gas or heat, the biological or chemical composition of the blood or of other bodily 
liquids to be introduced into the body by any means whatsoever.  
4.2.6. Surgicall y invasive BEM.  
4.2.7. Non -invasive BEM connected to active medical equipment in classes 2, 3 or 4.  
4.2.8. All material for dentures and orthodontic appliances, plus their accessories.  
4.2.9. Active BEM used to clean and sterilise other BEM.  
4.2.10. Active  BEM for treatment to administer or exchange energy from or to the body.  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
4.2.11. Active BEM for diagnosis, which supplies energy with a view to generating images or 
monitoring physiological processes.  
4.2.12. All active BEM used to administer or remove dru gs, bodily fluids or other substances to or 
from the body.  
4.2.13. Equipment for “in vitro” diagnosis for personal use to detect pregnancy, for fertility testing, 
and to determine cholesterol and glucose levels.  
4.2.14. Contraception such as sponges, diaph ragms and their accessories and applicators.  
4.2.15 Solutions for packaging, disinfecting and sterilising BEM.  
4.2.16 Non -invasive BEM which acts as a gauge, tester or support for quality control of other 
BEM.  
4.2.17 BEM for in vitro diagnosis including th at used to determine the presence of or exposure to 
transmitted agents or to move patients, with the exception of those in classes 3 and 4.  
4.2.18. Active BEM used to emit ionising radiation, including any equipment or software used for 
inspection or monit oring, either as equipment or to directly influence its performance, which has 
been designed to be used in radiographic mode, with the exception of that used for 
mammography, which is in class 3. 
4.3. BEM Class 3  
4.3.1. Invasive, surgical BEM to be absorbe d by the body or which will remain in the body for at 
least thirty consecutive days.  
4.3.2. Invasive or implantable BEM which remains in the body or is in contact with the surface of 
the eye for at least thirty consecutive days.  
4.3.3. Invasive BEM which i s presented to the public to prevent the transmission of infectious 
agents during sexual activity or to reduce the risk of these agents.  
4.3.4 All condoms not made of latex or natural membrane.  
4.3.5. Intra -uterine devices and their applicators used in con traception.  
4.3.6. Non -invasive BEM used to modify the biological or chemical composition of the blood or of 
other bodily liquids or fluids, with a view to being inserted into the human body by infusion or by 
another means, with the exception of those list ed in paragraph 4.2.5 of Class 2.  
4.3.7. Active BEM used to monitor, assess or diagnose a disease, disorder, abnormal physical 
condition or pregnancy, which may give rise to immediate danger if it produces the wrong result.   
4.3.8. Active BEM for treatmen t to administer or exchange energy from or to the body, which may 
be potentially dangerous given the nature of the administration or exchange, the intensity of the 
energy and the part of the body involved.  
4.3.9. All active BEM which is used to administer or remove drugs, bodily fluids or other 
substances to or from the body, the administration or removal of which is potentially dangerous 
given the amount and nature of the process of administration or exchange, the nature of the 
substance involved and the p art of the body affected.  
4.3.10. BEM used to control and monitor the functioning of active therapeutic equipment when it 
administers levels and forms of energy that are potentially dangerous for the human body, and 
when it administers and exchanges medici ne, bodily fluids or other potentially dangerous 
substances.  
4.3.11. Active BEM which includes a medicine or gases as an integral part and whose action in 
combination with the equipment can affect its bioavailability.  
4.3.12. Equipment for “in vitro” diagn osis which is used for:  
4.3.12.1. tests to detect the presence of or exposure to a transmitted agent where there is 
a risk that the wrong result could cause the death of or severe disability in the patient or in 
his or her descendants;   
4.3.12.2. tests us ed to handle patients suffering from a disease which poses an imminent 
threat to their lives or where the wrong result could place the patient’s life at risk;  
4.3.12.3. detecting the presence of a transmitted agent which causes an infection giving 
rise to a serious disease where there is a risk of contagion to the population;  
4.3.12.4. detecting the presence of or exposure to a sexual transmitted agent or detecting 
the presence of an infectious agent in cephalo -rachidien fluid or blood;  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
4.3.12.5. detecting or diagnosing cancer;  
4.3.12.6. genetic tests;  
4.3.12.7. detecting congenital disorders in the foetus;  
4.3.12.8. determining the phase or stage of a disease;  
4.3.12.9. tests used to type blood groups or tissue to ensure immunological compatibility 
of blood , blood components, tissue or organs during transfusion or transplant procedures;  
4.3.12.10. monitoring levels of drugs, substances or biological components where there is 
a risk that a wrong result could produce a situation involving danger or disadvantag e in 
terms of the patient’s life;  
4.3.12.11. all BEM for in vitro diagnosis for personal use except for those in Class 2 and 
Class 4.  
4.3.13  Active BEM used to emit ionising radiation, including any equipment or software used for 
control or monitoring eit her as equipment or which directly influences its performance, with the 
exception of that listed in Class 2.  
4.4. BEM Class 4  
4.4.1. Condom made from natural membrane.  
4.4.2. Invasive surgical BEM used for diagnosis, monitoring, controlling or correcting a  defect in 
the central cardiovascular system, the central nervous system or the foetus in the uterus.  
4.4.3. Non -invasive BEM used to modify the biological or chemical composition of the blood or of 
other bodily liquids or fluids, with a view to being inse rted into the human body by infusion or by 
another means, the characteristics of which mean that during the process of modification a 
foreign substance may be introduced in a potentially dangerous concentration.  
4.4.4. Active BEM for therapy used to admin ister or exchange energy from or to the body which 
is used to control and treat the condition of a patient through a self -control mechanism which can 
be potentially risky given the nature of the administration or exchange, the intensity of the energy 
and t he part of the body involved.  
4.4.5 All active BEM used to administer or remove drugs, bodily fluids or other substances from 
or to the body through a self -control mechanism, the administration or removal of which can be 
potentially dangerous given the amo unt and nature of the administration or removal process, the 
substance involved and the part of the body concerned.  
4.4.6. BEM used to disinfect or sterilise blood, tissue or organs which will be used in transfusions 
or transplants.  
4.4.7. BEM with the exc eption of BEM for in vitro diagnosis whose manufacture fully or partly 
includes tissue of animal origin or its derivatives, viable or not, as well as products obtained by 
using recombinant DNA technology . 
4.4.8. BEM for “in vitro” diagnosis used to detect the presence of or exposure to transmitted 
agents in blood, blood components, blood derivatives, tissue or organs to assess their suitability 
for use in transfusions or transplants.  
4.4.9. Mammary prostheses and tissue expansion devices in mammary prosthes es. 
4.4.10 BEM for “in vitro” diagnosis for personal use to detect the presence of the following sexual 
transmitted agents: HIV (Human Immunodeficiency Virus), HTLV (Human T -Cell Lymphotropic 
Virus), HBV, HCV and HDV (Hepatitis B, Hepatitis C and Hepatitis  D Virus).  
4.4.11 BEM for “in vitro” diagnosis used to detect the presence of a transmitted agent which 
causes an infection giving rise to a serious disease where there is a risk of contagion to the 
population.  
 
CHAPTER III  
Requirements for the registratio n of BEM  
Article 5. All BEM must come from a national manufacturer or importer authorised by the Ministry of Health 
and holding a valid permit.  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
BEM may be manufactured, imported, sold and distributed in the country if the relevant certificate is held 
certifying compliance with the rules and quality requirements applicable to it depending on its type.  
Article 6. Registration application file. In order to register BEM, a complete application file must be 
submitted to the Directorate of Registration and Inspe ction.  
6.1      The applicant must be the person legally responsible for the product in the country.  
6.2 Everything that is stated in the documents submitted for any procedures relating to the health 
registration of BEM shall be regarded as a sworn declar ation. Moreover, all the information must 
correspond.  
6.3 All certificates and official documents must be valid at the time of submission. With a view to 
ensuring that the file is valid throughout the process of revision of the health registration, the da te of 
issue must be at most one year and ten months from the date of receipt of the file, unless the 
documents indicate an earlier date.  
6.4. All certificates and official documents must be in Spanish or accompanied by their respective official 
translation .   
6.5 No corrections are permitted in the certificates or official documents submitted unless they are 
endorsed by the same body which issued the original document.  
6.6 All official documents issued abroad must be legalised in accordance with specific n ational laws.  
6.7 In the cases applicable and for the purpose of registering specific BEM, the applicant may refer to 
valid documents held in the archives of the Ministry. In this case, the applicant must mention the 
location of the original document.  
6.8.   The documentation submitted for the register must show clearly the name, model identification and, if 
possible, the code of each item of biomedical equipment or material to be registered.    
 
Article 7. All BEM must be entered on the health register pri or to use, sale or importation. The Class 1 
BEM listed in the annex to this Regulation is exempt from the health register. The list may be modified by 
the Ministry of Health by means of an administrative decision published in La Gaceta, the Puerto Rican 
Official Journal.  
To register Class 1 and 2 BEM, the originals of the following documents must be submitted to the 
Directorate:  
7.1. Application form for registration of BEM . The official, valid application form must be used, stating 
all the information requ ested. The form must be typed, without any corrections or erasures. The 
application form must be signed by the person legally responsible for the product. When submitting the 
form, the latter must produce his identity card. If he does not perform this proc edure in person, a copy of 
his identity card certified by a public notary may be enclosed with the form, on this one occasion.  
7.2. In the case of imported BEM, the Certificate of Free Sale and Use issued by the country of origin 
must be presented, duly au thenticated, certified by a consulate and accompanied by the official translation 
if the original language is not Spanish.  
7.3. Medical and technical specifications for BEM in Spanish when the original language was different, 
plus the instructions for use  of BEM for in vitro diagnosis.  
7.4. Certificate testifying to good practices by the manufacturer, issued by the competent authority in the 
country of origin, duly authenticated, certified by a consulate and accompanied by the official translation, 
when th e original language is not Spanish. In the case of sterilised BEM, the certificate must state that the 
sterilisation method has been validated.  
7.5. Authorisation of the source of emission in the case of BEM which emits ionising radiation.  
7.6 Settlement o f the payment defined by the Ministry according to the decree.  
For Class 2 “in vitro” equipment for diagnosis, in addition to the above, the following documents must be 
produced for registration:  
7.7. The international standard which contains the accuracy  and precision standards applicable to the 
BEM must be stated.  
7.8. The original labelling of the product in the case of equipment for “in vitro” diagnosis for personal use. 
If it is in a language other than Spanish, it must be accompanied by a translation  and the graphics for the 
new label.  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
Article 8. Class 3 BEM must be registered with the Ministry of Health. The originals of the following 
documents must be produced at the Directorate:  
8.1. Application f orm for registration of BEM. The official, valid app lication form must be used, stating 
all the information requested. The form must be typed, without any corrections or erasures. The 
application form must be signed by the person legally responsible for the product. When submitting the 
form, the latter must  produce his identity card. If he does not perform this procedure in person, a copy of 
his identity card certified by a public notary may be enclosed with the form, on this one occasion . 
8.2 In the case of imported BEM, the Certificate of Free Sale and Use  issued by the country of origin must 
be presented, duly authenticated, certified by a consulate and accompanied by the official translation if the 
original language is not Spanish.  
8.3. Medical and technical specifications for BEM in Spanish when the ori ginal language was different and 
the instructions for use of BEM for in vitro diagnosis.  
8.4. Certificate testifying to good practices by the manufacturer, issued by the competent authority in the 
country of origin, duly authenticated, certified by a consu late and accompanied by the official translation, 
when the original language is not Spanish. In the case of sterilised BEM, the certificate must state that the 
sterilisation method has been validated.  
8.5. Authorisation of the source of emission in the cas e of BEM which emits ionising radiation.  
8.6. Settlement of the payment defined by the Ministry according to the decree.  
8.7. List of the countries where the BEM is sold.   
8.8. Presentation of a monitoring programme for the BEM issued by the manufacturer.  
8.9. Summary in Spanish of the clinical trials conducted including the bibliographical references, 
establishing the safety and effectiveness of the BEM, with the complete study in digital or printed form.  
For Class 3 “in vitro” diagnosis equipment, in add ition to what is stated above, the following documents 
must be produced for registration:  
8.10.   The international standard which contains the accuracy and precision standards applicable to the 
BEM must be stated.  
8.11.  The original labelling of the produc t in the case of equipment for “in vitro” diagnosis for personal 
use. If it is in a language other than Spanish, it must be accompanied by a translation and the graphics for 
the new label.  
Article 9.  Class 4 BEM must be registered with the Ministry of Heal th. The originals of the following 
documents must be produced at the Directorate:  
9.1. Application f orm for registration of BEM. The official, valid application form must be used, stating 
all the information requested. The form must be typed, without any c orrections or erasures. The 
application form must be signed by the person legally responsible for the product. When submitting the 
form, the latter must produce his identity card. If he does not perform this procedure in person, a copy of 
his identity card  certified by a public notary may be enclosed with the form, on this one occasion . 
9.2. In the case of imported BEM, the Certificate of Free Sale and Use issued by the country of origin 
must be presented, duly authenticated, certified by a consulate and ac companied by the official translation 
if the original language is not Spanish.  
9.3. Medical and technical specifications for BEM in Spanish when the original language was different, 
plus the instructions for use of BEM for in vitro diagnosis.  
9.4. Certifi cate testifying to good practices by the manufacturer, issued by the competent authority in the 
country of origin, duly authenticated, certified by a consulate and accompanied by the official translation, 
when the original language is not Spanish. In the c ase of sterilised BEM, the certificate must state that the 
sterilisation method has been validated.  
9.5. Settlement of the payment defined by the Ministry according to the decree.  
9.6. List of the countries where the BEM is sold.   
9.7. Presentation of a m onitoring programme for the BEM issued by the manufacturer.  
9.8. Summary in Spanish of the clinical trials conducted including the bibliographical references, 
establishing the safety and effectiveness of the BEM, with the complete study in digital or print ed form.  
9.9. Copy of the risk analysis and evaluation and the measures to be taken to reduce risk which comply 
with the safety and efficiency requirements drafted by the manufacturer.  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
9.10. Bibliographical reference to reports published that relate to the  use, safety and efficiency of the 
BEM.  
9.11.   In the case of BEM manufactured using tissue and its human or animal derivatives, a certificate 
issued by the manufacturer indicating the biological safety of this.  
For Class 4 “in vitro” diagnosis equipment, in addition to what is stated above, the following documents 
must be produced for registration:  
9.12.  The international standard which contains the accuracy and precision standards applicable to the 
BEM must be stated.  
9.13.      The original labelling of t he product in the case of equipment for “in vitro” diagnosis for personal 
use. If it is in a language other than Spanish, it must be accompanied by a translation and the graphics for 
the new label.  
Article 10. For reconstructed, re -manufactured or used BEM , the following documents must be produced 
in addition to those mentioned in Articles 7, 8 or 9, depending on its classification:  
10.1 Declaration by the manufacturer which reconstructed or re -manufactured the BEM guaranteeing its 
quality, safety and efficiency . The declaration must be authentic, be duly certified by a consulate and 
be presented in Spanish or accompanied by a translation.  
10.2  Declaration by the registration manager guaranteeing the technical service to ensure proper 
maintenance.   
10.3   Decla ration by the person responsible guaranteeing the availability of spare parts for a period of at 
least three years.  
10.4.   Label.  
Article 11. The Certificate of Good Manufacturing Practices issued by the manufacturer may be replaced 
by a certificate issue d by an authorised certification body recognised by the Costa Rica Accreditation 
Body.  
Article 12. The requirements for registration may be presented electronically according to a procedure 
established by decision and in agreement with the guidelines laid down by law.  
Article 13. The Ministry of Health will evaluate the documentation presented in order to approve or reject 
approval of registration of the BEM. This will be done in two phases, as indicated below:  
1) Phase 1: Review according to legal requiremen ts 
 
The party concerned (the applicant) must go to the reception desk of the Customer Service Unit of 
the Directorate of Registration and Inspection, hereafter referred to as the Customer Service Unit, 
and produce the registration application together with  the documents mentioned in Articles 7, 8, 9 
and 10 of this Regulation, where appropriate.   
The Registration and Control Unit of the Directorate of Registration and Inspection is responsible for 
reviewing the technical and legal requirements of the docume nts, to which end it has fifteen (15) 
days starting from the receipt of the application for Class 1 and Class 2 BEM and a period of thirty 
(30) days from the date of receipt of the application for Class 3 and 4 BEM.  
Should the said review conclude that th e documents comply with the requirements, the applicant 
shall be granted Phase 1 approval within the period indicated.  
In the event that the documents and requirements requested for registration do not comply with the 
provisions in this Regulation, the Reg istration and Control Unit may inform the applicant, once and 
in writing, so that he can complete or correct the requirements omitted in the documentation, or so 
that he can clarify the information. The applicant has a period of ten (10) working days from the date 
of receipt of the document in which he is informed of the comments to produce the documents with 
all the corrections or comments mentioned, or the technical and legal arguments for the reasons 
why he considers that the comments should not be accep ted. This period interrupts the decision -
making period established.  
The above is without prejudice to the applicant’s possibility of asking in writing, with the relevant 
technical and legal justifications, and prior to the expiry of the ten (10) days, for an extension of the 
period, which he must present at the reception desk of the Customer Service Unit. In this case, the 
Registration and Control Unit may grant an additional period of up to three (3) months, except 
where the situation is very complicated i n technical terms or it is materially impossible to ensure 
compliance in that time, in which case a longer period is requested. The applicant must provide 
arguments to support and provide evidence of this situation.   
Once the applicant submits the correct ed documents, the remainder of the period laid down for the 
decision -making shall start to run, within which the Registration and Control Unit must take a 
decision and communicate the decision to the applicant.  
Once the period of ten (10) working days has  lapsed, or where appropriate the extension of the 
period, and the applicant has not complied with the warnings set down, the Registration and Control Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
Unit shall proceed as of right to shelve the procedure. The applicant must commence a new 
procedure if he  wishes, complying with all the requirements laid down in Articles 7, 8, 9 and 10 of 
this Regulation, where appropriate.   
In the cases in which the applicant considers that the comments made by the Registration and 
Control Unit are unjustified or that the  requirements mentioned have been complied with, he may 
initiate the corresponding ordinary and extraordinary proceedings before the Directorate of 
Registration and Inspection  or, where appropriate, before the Ministry itself, as laid down in Article 
342, following and concordant, of the General Law on Public Administration.  
 
2)   Phase 2: Technical evaluation of the requirements  
 
The Registration and Control Unit is responsible for the technical evaluation of the technical 
documents and studies forming par t of the file, to which end it has a period of thirty (30) days from 
the date of receipt of the file with the Phase 1 approval decision.  
If the technical evaluation confirms the compliance of the said technical documents and studies, the 
BEM shall be gran ted registration and the respective registration certificate shall be issued within 
the period laid down.  
In the event that the technical documents and studies requested for registration do not comply with 
the provisions in this Regulation, the Registratio n and Control Unit has twenty -five (25) days from 
the date of receipt of the file to inform the applicant, once and in writing, so that he can complete or 
correct the requirements omitted in the documentation, or so that he can clarify the information .  
This warning suspends the Phase 2 approval period. The applicant has a period of ten (10) working 
days from the date of receipt of the document informing him of the comments, to submit the 
documents with all the corrections and comments mentioned, or to prov ide technical and legal 
arguments why he considers that the comments should not be accepted.    
The above is without prejudice to the applicant’s possibility of asking in writing, with the relevant 
technical and legal justifications, and prior to the expiry  of the ten (10) days, for an extension of the 
period, which he must present at the reception desk of the Customer Service Unit. In this case, the 
Registration and Control Unit may grant an additional period of up to three (3) months, except 
where the situ ation is very complicated in technical terms or it is materially impossible to ensure 
compliance in that time, in which case a longer period is requested. The applicant must provide 
arguments to support and provide evidence of this situation.   
Once the ap plicant submits the corrected documents, the remainder of the period laid down for the 
decision -making shall start to run, within which the Registration and Control Unit must take a 
decision and communicate the decision to the applicant.  
Once the period o f ten (10) working days has lapsed, or where appropriate the extension, and the 
applicant has not complied with the warnings set down, the Registration and Control Unit shall 
proceed as of right to shelve the procedure. The applicant must commence a new pr ocedure if he 
wishes, from the previous phase 1,  and must comply with all the requirements laid down in Articles 
7, 8, 9 and 10 of this Regulation, where appropriate.   
In the cases in which the applicant considers that the comments made by the Registrati on and 
Control Unit are unjustified or that the requirements mentioned have been complied with, he may 
initiate the corresponding ordinary and extraordinary proceedings before the Directorate of 
Registration and Inspection  or, where appropriate, to the Min istry itself, as laid down in Article 342, 
following and concordant, of the General Law on Public Administration.  
Article 14. T he BEM registration shall remain valid for five years, without prejudice to the powers of 
cancellation or modification conferred on the Ministry by the General Law on Health.  
Article 15. The BEM registration may be renewed for an equivalent period, to which end the applicant 
must produce the following documents before the Directorate:  
15.1.  Registration form published in the Puerto Rica, Official Journal ( La Gaceta ), and signed by the 
applicant.  
15.2.  Sworn statement that the conditions of registration of the BEM have not changed.  
15.3.  Proof of payment.  
15.4.  Certificate of Good Manufacturing Practices issued by the competent author ity in the country of 
origin.  
15.5. Certificate of Free Sale duly authenticated and certified by a consulate for imported EBM.  
Article 16. The Ministry shall grant a single registration to each BEM, BEM family, BEM group, families of 
BEM groups, family of test kits, and systems or kits. Registration numbers shall be assigned in line with 
the following conditions:    Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
16.1.  The Ministry shall assign a single registration number to each BEM registered.  
16.2.  In the case of families of BEM, families of test kits and of systems, all the members of a BEM family 
or the components of the system may be the subject of a single registration, to which a single 
registration number shall be assigned followed by an alphanumeric code which identifies each 
member. If anot her member of the family or component of the system is to be included, the 
Directorate must be notified by means of a formal written request signed by the registration 
manager.  
16.3.  BEM groups and families of BEM groups shall be registered under a singl e registration number. Any 
change in the combination of BEM forming the group or family groups will require a new 
registration.  
16.4.  Test kits and families of test kits shall be the subject of a single registration, to which a single 
registration number  shall be assigned followed by an alphanumeric code which identifies each 
member. Any change in the composition of the test kit will require a new registration.  
16.5   In all cases, a single registration will involve a single payment.  
Article 17.  In accor dance with Article 6.1 of the World Trade Organisation Agreement on Technical 
Barriers to Trade, the Ministry of Health may accept the results of procedures for assessing the 
compliance of registration systems implemented by government agencies which have complied with the 
procedure laid down officially in line with the guidelines issued by the WTO in this respect, provided that 
these entities can assure a degree of compliance with the Technical Regulations and relevant rules that is 
equal or superior to th ose laid down in our country, based on:  
a. The experience, knowledge and confidence that exists with respect to the relevant measures for 
assessing the safety and efficiency of BEM in these countries.  
b. The laws of the recognised countries objectively demonstr ate that an adequate level of protection is 
reached in relation to the safety and efficiency of BEM.  
c. The health inspection system in the countries recognised effectively and efficiently covers the 
requirements established.  
d. There has been regular and smoot h trade with no history of rejection of products for health reasons.  
Article 18.  Mindful of the above, the Ministry of Health exempts the BEM manufactured and registered in 
the countries whose compliance assessment systems have been recognised by the Mini stry of Health from 
the following requirements:  
a. Certificate of Good Manufacturing Practices.  
b. List of countries in which BEM is sold.   
c. Presentation by the manufacturer of a monitoring programme for BEM.  
d. Summary in Spanish of the clinical trials including bibliographical references, which 
demonstrate the safety and efficiency of the BEM, and the full study in electronic or print 
format.  
e. Copy of the risk analysis study and the measures to be taken to reduce risk, which must 
comply with the requirements of sa fety and efficiency, drawn up by the manufacturer.  
f. Bibliographical reference of reports published concerning the use, safety and efficiency of the 
BEM.  
g. In the case of BEM manufactured using tissue and its human or animal derivatives, a 
certificate issued b y the manufacturer indicating the biological safety of this.  
h. The international standard which contains the accuracy and precision standards applicable to 
the BEM must be stated.  
If the Ministry deems this necessary, and provides technical and scientific ju stification, it may request any 
one of the above -mentioned documents during or after the registration process for the purpose of verifying 
the safety and efficiency of the BEM.  
Article 19. In an emergency case or instance of public necessity, the Ministry  of Health may grant 
authorisation to a health care provider or social welfare organisation to import and use unregistered BEM. 
To this end the organisation concerned shall submit a formal request to the Ministry containing justification 
for this. The Mini stry shall decide on the request within a period of no more than ten days of receipt of this 
request.  
Article 20.  Changes in the information or conditions under which registration of BEM is granted or of an 
importer who is not a registration manager must b e notified to the Ministry of Health, with, where 
appropriate, the following documents:   Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
20.1 Change of the applicant’s trade name:  
a) Complete form notifying change after registration.  
b) Certificate issued by the National Register where the change of na me is recorded.  
c) When the undertaking is not located in the country and it changes its trade name abroad, the certificate 
of the change must be produced, duly certified by a consulate  
 
20.2 Change of manufacturer:  
a) Complete form notifying change after registration.  
b) Verification of the validity of the new manufacturer’s Operating Permit, for national manufacturers.  
c) If the product is manufactured abroad, the valid Certificate of Free Sale must be produced.  
d) Certificates of Registration of the orig inal BEM.  
 
20.3 Transfer of the registration:  
a) Complete form notifying change after registration.  
b) Legal document certifying the transfer.  
c) Certificate of Registration of the original BEM.  
 
20.4 Change of scope of the trade mark or product name  
a) Co mplete form notifying change after registration.  
b) Certificate of Registration of the original BEM.  
c) Draft of new label or original label.  
 
20.5  Change in composition of a family, group, family of groups, systems, test kit family or kits:  
a) Complete f orm notifying change after registration.  
b) Documents describing the characteristics of the new components of family, group, family of groups, 
systems, test kit family or kits.  
c) Valid Certificate of Free Sale.  
d) Certificate of Registration of the origin al BEM.  
 
CHAPTER IV  
 
IMPORTATION AND STORAGE  
 
Article 21. All imports of BEM require storage authorisation issued by the Ministry.  
 
21.1. Only importers holding a current Operating Permit are allowed to import BEM.  
 
21.2.   Apart from the exceptions provide d for in this Regulation, all imported BEM must be validly 
registered.  
 
21.3.  All importers and distributors of the product who wish to apply for storage authorisation must 
produce the following documents:  
a) The Customs Clearance Form (FAD).  
b) The bills  of lading and invoices shall be requested depending on the inspection programme 
established.  
 
21.4. The Ministry may authorise the importation of BEM without registration in the following cases:  
a) when it is used for research purposes supported by duly a uthorised protocols that are in line with 
the respective laws.  
b)  Samples with no commercial value according to current law.  
c) When it complies with the provisions set down in Article 19 of this Regulation.  
d) When it is maintained under a system of free  zones or active processing in order to be 
completely re -exported to another country.  
e) When it is donated BEM which has been approved by the Ministry of Health according to the 
provisions in this Regulation.  
 
Such imports must be processed by means of a letter of application in which the situation is clearly 
explained, enclosing the documents required as stated under point 21.3. The Ministry shall take a decision 
within a maximum period of 10 days.  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
Article 22. In the event of the importation of products t hat are already registered with the Directorate by 
natural or legal persons other than the registration manager, the applicant must register as the BEM 
importer, producing the official form and payment of the duty for each product as laid down by law. In t his 
case, the natural or legal person registered as the BEM importer is the person legally responsible for any 
failure to comply with national laws.  
The distributors authorised by the registration manager or product owner duly registered shall be exempt 
from this requirement provided that the said manager or owner has informed the Directorate previously 
and explicitly of the natural or legal persons who are distributors.  
CHAPTER V  
Donations  
Article 23.  All health service providers, academic institutions and  social welfare organisations which 
receive donations of unregistered BEM must apply for authorisation prior to its entry into the country, 
producing the following documents for the Directorate on Registration and Inspection:  
23.1.  Official, valid BEM don ation application form indicating all the details requested, which must be 
typed, without corrections or erasures. The application must be signed by the person legally responsible 
for the beneficiary institution or organisation.  
23.2.  Letter issued by the donating entity stating that the donated BEM is in good condition and functions 
properly, safely and efficiently.  
23.3.  Copy of the customs clearance document or loading bills.  
23.4. Inspection report produced by the technical staff of the Health Managemen t Area corresponding to 
the Entry Customs or Supervisory Store. To this end, the Health Management Area shall deal with the 
application within a maximum period of ten days.  
The Directorate of Registration and Inspection shall assess the application and iss ue a decision within a 
maximum period of three days.  
The use for any reason whatsoever of donated BEM which has not been approved by the Ministry of 
Health is prohibited.  
CHAPTER VI  
Prohibitions  
Article 24. BEM for “in vitro” diagnosis for personal use men tioned under points 4.3.12.4 and 4.4.10 of this 
Regulation shall not be authorised by the Ministry of Health for sale to the general public.  
CHAPTER VII  
BEM labelling  
Article 25. BEM labels must contain the following information in Spanish.  
25.1. Name of the BEM.  
25.2.  Country of origin.  
25.3. Manufacturer’s name.  
25.4. Address of the importer or distributor of the BEM to be sold to the general public.  
25.5. Date of manufacture, series and model.  
25.6.  Expiry date or date of end of useful life.  
25.7. An indication regarding sterilisation, if declared by the manufacturer.  
25.8.  Any special storage condition applicable to the BEM.  
25.9.  Purpose or intended use of the BEM.  
25.10 . Warning statements and notes.  
25.11 . Instructions for use.  
25.12 . Stat ement as to whether the BEM is reconstructed, re -manufactured or used.  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
25.13.  For BEM for “in vitro” diagnosis for personal use, the following mention must be shown visibly and 
indelibly: “this self -control test is solely for guidance and does not provide  a definitive diagnosis”.  
The label must be in Spanish or, where the label is in another language, there must be an additional 
adhesive label with the translation.  
 
 
CHAPTER VIII  
BEM inspections  
Article 26. All persons responsible for BEM must report to t he Directorate of Registration and Inspection 
all problems of malfunctioning or incidents detected in the use of BEM when they occur.  
Article 27. State verification or inspection of compliance with the rules governing registration and of the 
provisions la id down in this Regulation shall be conducted by the Ministry of Health or by inspectors 
authorised for this purpose by the Ministry. Verification of metrological specifications shall be the 
responsibility of the Costa Rica Metrology Laboratory ( Laboratori o Costarricense de Metrología  -
LACOMET), in which respect it shall cooperate with the Ministry of Health.  
Article 28. Should it emerge that there has been a failure to comply with any of the relevant regulations or 
that a false declaration has been made wh en registering BEM, the special health measures and the 
sanctions laid down in the General Law on Health shall be applied. Similarly, should any negative or 
damaging incident related to the use of any type of BEM come to the attention of the Ministry of He alth, the 
Ministry may ask for the withdrawal of the equipment or material from the market as a precautionary 
measure. If there has been an offence, and depending on its seriousness, the Ministry of Health shall 
apply the due process and may cancel registr ation of the product, stopping all imports of it. This is without 
prejudice to the civil and administrative legal proceedings that may apply.  
Article 29. The Minister of Health is authorised to amend the decree to update the classification of BEM 
quoted i n Chapter 2 of this Regulation in order to integrate administrative decisions as laid down in Article 
4.  
Article 30. Executive Decree No 32425 -S of 22 June 2005 and its reforms are hereby abrogated.  
This shall come into force on publication.  
 
TRANSITIONAL  PROVISIONS  
Transitional provision I. The Certificate of Good Manufacturing Practices required under Articles 7, 8, 9, 
10 and 15 shall not apply until a Regulation on Good Manufacturing Practices for BEM is adopted at 
national level.  
Transitional provision  II. The requirements laid down in this Regulation for Classes 1 and 2 BEM shall 
come into force twelve months after the entry into force of this decree; during this period, registration shall 
be voluntary. The requirements laid down in this Regulation for  Classes 3 and 4 BEM shall come into force 
six months after the entry into force of this decree; during this period, registration shall be voluntary.  
Transitional provision III. All BEM whose purchase has already been decided by state health service 
provid ers prior to the entry into force of this Regulation may be imported and used by these institutions. To 
this end, the contractor for the institutions must submit a note to the Ministry of Health bearing the stamp of 
approval of the contracting entity or bo dy. 
Transitional provision IV.  The provision in Article 11 shall come into force once the Costa Rica 
Accreditation Entity grants the corresponding accreditation.  
Adopted by the Presidency of the Republic, at San José, on the           day of the month of         , two 
thousand and seven.  
 
OSCAR ARIAS SÁNCHEZ  
President of the Republic  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
 
 
 
 
MARÍA LUISA ÁVILA AGÜERO  
Minister of Health  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
 
 
ANNEX 1  
(Regulation)  
 
Class 1 products  
not requiring registration  
 
Ø Sanitary towels.  
Ø Reusable diapers for adult urinary inco ntinence.  
Ø Hospital bed linen.  
Ø Reusable clothing for patients and doctors.  
Ø Plates, glasses, cups, trays, pots, mugs, cutlery and other items of any type 
of material for hospital use.  
Ø Containers with lids or without lids made of stainless steel or plastic to  
store materials, accessories and medical products. Pill boxes.  
Ø Tongue depressor.  
Ø Hygiene items for patients.  
Ø Clothes.  
Ø Gloves for domestic duties.  
Ø Furniture for hospital use (chairs, benches, bedside tables, steps, manually -
operated beds, hydraulic beds, birthing beds)  
Ø Scales for home use.  
Ø Hydro -massage bathtubs.  
Ø Bulbs for common use.  
Ø Manual or electrical combs for removing lice.  
Ø Bags for hospital waste.  
Ø Exercise machines except for those designed for therapeutic use.  
Ø Chamber pots.  
Ø Supports for knees, elb ows, necks, fingers and ankles.  
Ø Pregnancy corset.  
Ø Aesthetic moulding garments.  
Ø Elastic stockings with pressure of under 18 mm of mercury.  
Ø Manual toothbrushes.  
Ø Dental floss.  
Ø Bags for hot or cold water and devices for applying ice that are disposable, 
reusable and chemical.  
Ø Heaters.  
Ø Humidifiers.  
Ø Applicators.  
Ø General chemical laboratory equipment (test -tubes, Erlenmeyer flasks, 
beakers, non -graduated pipettes, probe holders, filter paper, glassware in 
general apart from test -tubes used to take blood sample s). 
Ø Containers for air generation system plus accessories.  Proposal for a BEM Regulation, including the Directorate of Registration and Inspection 
(DRC) and Costa Rican Chamber of Foreign Commerce (CRECEX) versions  
03-12-07 
Ø Growing medium for environmental monitoring.  
Ø Antimicrobial susceptibility disc dispenser.  
Ø Hearing aid moulds.  
Ø Anti-snoring devices.   
Ø Plaster for use in dentistry.  
Ø Plaster cutters.  
Ø Plaster and meta l polishers.  
Ø Polisher.  
Ø Frames for x -rays.  
Ø Hook for displaying x -rays.  
Ø Paper for cephalometry.  
Ø Brushes to apply material.  
Ø Boxes for storing dental devices.  
Ø Instrument organisers.  
Ø Equipment organisers.  
Ø Pumice stone for use in dentistry.  
Ø Rubber containers.  
Ø Spatulas for mixing plaster.  
Ø Plaster rings.  
Ø X-ray viewing screens.  
Ø Table for x -rays.  
Ø Eye charts.  
Ø Ear and eye droppers.  
Ø Protective helmets.  
Ø X-ray dryers.  
Ø Hand exercise devices.  
Ø Magnifying glasses.  
Ø Neck pillows on sale without prescription.  
Ø Kit for shaving pa tients.  
Ø Orthopaedic shoes.  
Ø Stockings for fractures.  
Ø Spoons for measuring medicine.  
 
 
 Other products not requiring registration  
Ø Massage devices for home use.  
Ø Sexual toys with the exception of condoms and lubricant gels and creams 
for internal use.  
Ø Exercise  machines