Bio-Chemical Reagent

HEALTH LICENSE/REGISTRATION

Bio-Chemical Reagent

1 Concept

2 Services

3 Registration – Requirements

4 Health License / Sanitary Registration NOT Requirement Certificate

5 Product classification Certificate

6 Health License Validity

1. Concept

Are the medical devices for human use intended for in vitro diagnostic use of samples derived from the human body, or to provide information for the diagnosis, follow-up or compatibility of physiological condition, state of health, disease or congenital malformations. This includes reagents, reagents biochemical, calibrators, control materials, sample containers, software and instruments or appliances, accessories or other related items.

2. Services

  • Obtaining the Health Registry / Health License certification for Foreign Biochemical In Vitro Diagnostic Reagents.
  • Legal and Technical Holding
  • Modification of the Health Registry/ Health License certification for Foreign Biochemical In Vitro Diagnostic Reagents.
  • Re-registration of the Health Registry/ Health License for Foreign Biochemical In Vitro Diagnostic Reagents.
  • Health License / Sanitary Registration NOT Requirement Certificate

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. User manual
  7. Description and interpretation of the batch code
  8. Description of functional components, parts and structure (if apply)
  9. Stability certificate, only for medical devices for human use that requires an expiration date (if apply)
  10. Label project for Ecuador commercialization.
  11. Stability certificate, only for medical devices that requires an expiration date (if apply)
  12. Quali-quantitative formula of the drug with which it is find the medical device (if apply).
  13. Biocompatibility Studies (Based on ISO 10993) (if apply)
  14. Bifunctionality studies: Specific clinical studies for medical technology or scientific articles with clinical evidence on the device, Studies applicable to in vitro diagnostic agents, Precision / reproducibility studies, Sensitivity studies Specificity studies (if apply).
  15. Certificate of Compliance by the Manufacturer
  16. Good Manufacturing Practices (GMP) or ISO 13485 Certificate (if apply)
  17. IEC 60601 Certificate of compliance (if apply)

4. Health License

Service that verifies if the product requires or not requires the sanitary registration / health license for the distribution, commercialization, and import.

5. Product Classification

Process directed to informing the user about the category to which the product belongs, which requires obtaining health registration for subsequent marketing.

6. Health License Validity

The License will be valid for 5 years, counted from the date of its issue and may be renewed for equal periods. (Re-registration).

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