Colombia is a sovereign state largely situated in the northwest of South America, with territories in Central America. Marketing your medical device in Colombia requires registration with the National Food and Drug Surveillance Institute (INVIMA), the country’s medical device regulator.
The first step towards INVIMA regulatory approval is to determine the correct classification of your medical device. Device classification in Colombia follows a four-tiered risk model (Class I, Class IIa, Class IIb and Class III) that is similar to the classification scheme used in Europe.
Registration Process of Device in Colombia
Once you determine the correct classification of your medical device, you must complete the following steps to bring your device to market in Colombia.
- 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.
INVIMA approval for lower risk devices
INVIMA allows immediate acceptance of Class I and IIa device submissions. The full technical file must still be submitted for review by INVIMA, but certificate issuance is immediate and manufacturers can begin importing right away. Once the formal review begins, the manufacturer must respond to INVIMA’s requests in order to maintain the registration. This allowance was implemented to help address the long review times and large backlog experienced within the Ministry of Health.
Class IIb and III devices are not eligible for this process and must wait until formal review and approval are complete, generally within six months, to begin selling.