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.