3. Registration

1. Legalized Free sale certificate (FSC) or Export Certificate of the origin country.
2. Legalized authorization from the foreign manufacturer or from the owner of the product to the legal holding in Ecuador, to submit the registration process. This document must be translated into Spanish.
3. Information about the medical device: risk level, generic denomination, classification, type, and brand.
4. Description of the product development process.
5. Description of the composition of all containers (primary, secondary, tertiary).
6. Description of materials and raw materials (only for active therapeutic human medical devices)
7. User manual
8. Description and interpretation of the batch code
9. Description of functional components, parts and structure (if apply)
10. Stability certificate, only for medical devices for human use that requires an expiration date (if apply)
11. Label project for Ecuador commercialization.
12. Stability certificate, only for medical devices that requires an expiration date (if apply)
13. Quali-quantitative formula of the drug with which it is find the medical device (if apply).
14. Biocompatibility Studies (Based on ISO 10993) (if apply)
15. Bifunctionality studies: Specific clinical studies for medical technology or scientific articles with clinical evidence on the device (if apply).
16. Certificate of Compliance by the Manufacturer
17. Good Manufacturing Practices (GMP) or ISO 13485 Certificate (if apply)
18. IEC 60601 Certificate of compliance (if apply)