Medical Device Registration in
Colombia
Ministry of Health
Ministry of Health and Social Protection of Colombia
Regulatory Authority
National Food and Drug Surveillance Institute (INVIMA)
Official Language
Spanish
Classification
Class I, IIa, IIb, III
Registration Process
- 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.
Documents Required
- 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)
Applicable QMS
ISO 13485:2016
Registration Timeline
- Class I and IIa device should take less than 1 month.
- Class IIb and III devices may take up to 6 months.
Authorized Representative
Yes
License Validity
10 years with exceptions.
Special Notes
- Documents and Labels should be in Spanish.