Medical Device Registration in
Ministry of Health
Class I, IIa, IIb, III
- Appoint an in-country representative, such as a Legal Representative, if you have no local presence in Colombia.
- Obtain a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from your home country or an INVIMA recognized market.
- Provide a quality system certificate, such as ISO 13485.
- Provide product information and the commercial history of the product; test reports will be required for Class IIa, IIb and III devices, and clinical data will be required for Class IIb and Class III devices.
- Submit these materials to INVIMA in Spanish and pay required application fee.
- Once approved, INVIMA will issue a registration certificate.
- Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG)
- Quality system certificate (e.g., ISO 13485, GMP).
- Product information and commercial history of the product
- Declaration of conformity (CoF)
- INVIMA’s application form
- Technical and legal documentation (translated to Spanish)
- Class I and IIa device should take less than 1 month.
- Class IIb and III devices may take up to 6 months.
10 years with exceptions.
- Documents and Labels should be in Spanish.