Medical device registration in Costa Rica - a brief guide

Medical device companies seeking to enter the market of Costa Rica must demonstrate regulatory compliance with local regulations and register their products with the national regulatory authorities.

National authorities of Costa Rica responsible for medical devices

Registration and control of medical devices in Costa Rica is the direct responsibility of the Ministry of Health of Costa Rica - Ministerio de Salud de Costa Rica.

Medical device regulations of Costa Rica

There are a number of regulations applicable to medical devices and relevant for the registration of medical devices in Costa Rica:

• Law No. 5395 - General Health Law
• Decree No. 34482-S. Regulation for the registration, classification, import and control of medical devices
• Decree 32780-S - Medical device registration, inspection, surveillance and control fees
• DAJ-RM-1151-08 - Medical device equivalence procedure
• Communiqué DAC-UPS-002-11 - Recognition of the United States medical device clearance and approval procedures
• Class-, type- and procedure-specific documents and guidelines

Medical device definition in Costa Rica

In Costa Rica medical devices fall under the definition of "Biomedical equipment and material" (Equipo y material biomédico - EMB).

EMB is defined as instrument, device, equipment, material, software or another item, used alone or in combination and intended by the manufacturer to be used in humans with any of the following purposes: diagnosis, prevention, control, treatment, alleviation, relief or compensation of a disease, injury or deficiency; investigation, replacement or modification of anatomical structures or of physiological processes; conception control - provided that the product does not exert its function by pharmacological, immunological or metabolic mechanisms.

Classification of medical devices in Costa Rica

Costa Rica has a medical device classification system similar to Health Canada’s classification. The classification rules are set forth in article 4 of the Regulation for the registration, classification, import and control of medical devices (Decree No. 34482-S).

Class 1 medical devices in Costa Rica are exempt from the registration procedure. Class 2 products have a simplified registration procedure, while Class 3 and 4 devices will have higher requirements, such as clinical studies.

Class 3 and 4 devices that are listed, cleared, or approved with the US FDA are eligible for the simplified registration procedure, which is similar to the Class 2 requirements.

General requirements for medical device registration documentation in Costa Rica

The documents required for the medical device registration are listed in the regulation Para el registro de Equipo y Material Biomédico (EMB) issued by the Ministry of Health. The registration dossiers differ from class to class.

Requirements for all classes

1. The Free Sale Certificate, Certificate of Foreign Government, Certificate of Export or equivalent. The certificate must indicate the name of the medical device to be registered and must indicate that the product is freely sold in the country of origin. It must be signed by the responsible authorities of the country of origin, notarized and consularized
2. The manufacturer's information: email, telephone number and country of the manufacturer, distributors contact information
3. Medical device classification.

For class 2 medical devices:

In addition to the documents listed above:

1. Medical and technical specifications
2. Instructions for use 
3. Sterilization process description (if applicable)
4. Pictures of the product.

For class 3 medical devices:

In addition to the documents submitted for all classes:

1. Medical and technical specifications
2. Instructions for use 
3. Sterilization process description (if applicable)
4. Pictures of the product.
5. List of countries where the medical device is sold
6. Post-market surveillance plan
7. Summary of clinical trials demonstrating safety and efficacy
8. Clinical studies reports
9. Packaging information (in the case of in vitro products, this must include primary and secondary packaging (if applicable)):
• Medical device's name
• Country of origin
• Manufacturer's name
• Address of the importer or distributor
• Date of manufacture, series and model
• Expiration date or shelf life
• Sterility (if applicable)
• Any special storage conditions applicable to the product
• Intended use 
• Warning notes and symbols
• Instructions for use
• Indicate if the EMB is used, rebuilt or remanufactured
• For in vitro diagnostic equipment for self-use add in the form visible and indelible the following legend:  "Esta prueba de autocontrol es únicamente orientadora y no brinda un diagnóstico definitivo" (This self-used test is used for guidance only and does not provide a definitive diagnosis).  Labeling must be in Spanish or include the translation into Spanish.

For class 4 medical devices:

In addition to the documents submitted for all classes:

1. Medical and technical specifications
2. Instructions for use 
3. Sterilization process description (if applicable)
4. Pictures of the product.
5. List of countries where the medical device is sold
6. Post-market surveillance plan
7. Summary of clinical trials demonstrating safety and efficacy
8. Clinical studies reports
9. Packaging information
10. Reference of published reports related to the use, safety and efficacy of the medical device
11. In the case of medical devices containing tissues and their derivatives of human or animal origin - biological safety certificate.

Medical device registration process in Costa Rica

The Ministry of Health reviews the registration documentation in two phases:

Phase 1: Legal review

The applicant submits to the Ministry of Health the registration request with some of the registration documentation listed above. 

The adequacy and legal compliance of documentation is assessed within a period of fifteen days class 2 devices and a period of thirty days for class 3 and 4 devices.

If the review outcome is positive, the applicant receives the Approval of Phase 1.

Phase 2: Technical review

The applicant submits the full registration dossier and the Approval of Phase 1. If the technical review demonstrates compliance with the requirements of the Ministry of Health, the applicant receives a Registration Certificate, which is valid for 5 years.