Medical device registration in Ecuador - a brief guide

Medical devices in Ecuador are regulated by the national regulatory and surveillance agency and the legal framework comprised of a number of official regulations. All medical devices placed on the Ecuador's market must be registered and compliant with local laws and regulations.

Medical device national regulatory authority of Ecuador

Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) is responsible for medical devices in Ecuador. Accordingly, the medical device registration in Ecuador is regulated by this agency.

Medical device regulations in Ecuador

There are a number of laws and regulations applicable to medical devices.

• Health Law
• Executive Decree No. 1583, RO/Sup 349, June 18, 2001
• Reglamento y Control Sanitario de Dispositivos Medicos y Dentales (2009)
• Reglemento Para El Registro y Control Sanitario de Dispositivos Médicos, reactivos Bioquimicos y Diagnostico y Productos Dentales (2013)
• Ministerial Agreement No. 0000230, 30 May 2007 (Ley No. 2000-12)
• Ministerial Agreement No. 205
• Resolution ARCSA-DE-026-2016-YMIH (regulation on registration and control of medical devices) amended by Resolution ARCSA-DE-030-2018-JCGO

Medical device definition in Ecuador

According to Reglemento Para El Registro y Control Sanitario de Dispositivos Médicos, reactivos Bioquimicos y Diagnostico y Productos Dentales (Art. 2): medical devices are articles, instruments, apparatus, appliances and mechanical inventions, including their components, parts or accessories, manufactured, sold or recommended for use in diagnosis, cure or palliative, preventing a disease, disorder or abnormal physical state or its symptoms to replace or modify the anatomy or a physiological process or control. It includes amalgams, varnishes, sealants and similar products and are:

1. Medical devices transient use: intended for continuous use for less than 60 minutes.
2. Medical devices for short-term use, continuous use for a period of up to 30 days.
3. Medical devices for long-term use for more than 30 days.

Medical device classification in Ecuador

Ecuador's medical device classification is risk- and rule-based. The classification rules are laid down in Article 16 of Reglamento y Control Sanitario de Dispositivos Medicos y Dentales (2009). There are four classes of medical devices in Ecuador: I, II, III, IV.

Diagnostic products are divided into the same four classes, but the classification rules are defined separately - Article 23 of Reglamento y Control Sanitario de Dispositivos Medicos y Dentales (2009).

General requirements for medical device registration documentation in Ecuador

The following information must be submitted to ARCSA for the purpose of medical device registration.

Authorized representative's documents

1. The appointment of the authorized representative 
2. Authorization granted by the owner of the product for registration purposes - duly legalized authorization from the owner of the product, in which the applicant is authorized to obtain the medical device registration in Ecuador. The responsibilities of the registration holder should be described in detail and clearly expressed
3. Applicant's operating permit granted by the competent health authority
4. List of medical devices to be registered
5. Fee receipt

Manufacturer's documents

1. Certificate of Free Sales, Certificate of Foreign Government, Export Certificate, or equivalent document in which it is declared: commercial name of the product, description of the product, manufacturer(s) and the owner of the product
2. GMP Certificate granted by the health authority of the country of origin or the ISO Certificate granted by an accredited institution. All copies should be notarized.

Technical documentation

1. Quality reports issued by the manufacturer including signature, name and position of the responsible person
2. Sterility reports issued by the manufacturer including signature, name and position of the responsible person
3. Specifications of the finished product
4. Product description. Description of the functional components, parts and structure of the medical device including: lists, diagrams, images or drawings of the functional components
5. Description of the raw materials
6. Stability reports signed by the responsible person who carried out the tests
7. Interpretation of the batch and series code, with signatures, names and positions of responsible persons
8. Labels and instructions for use, catalogs, brochures etc.  Labels must be in Spanish or contain other languages so long as it includes Spanish. Information on the name of the product, brand name, contents of the packaging, etc. must be included on the label (Reglamento y Control Sanitario de Dispositivos Medicos y Dentales , Art. 14)
9. Description and technical specifications of the primary and secondary packaging
10. Information on the manufacturing process including the flow chart of the manufacturing process of the medical device for human use
11. Biofunctionality reports
12. IEC 60601 certificates (if applicable)
13. Biocompatibility Studies based on ISO 10993 (if applicable)
14. Scientific evaluation of the product

Registration cost

The standard fee for medical device registration in Ecuador amounts to 904.34 US dollars.