INVIMA Medical Device Registration and Approval in Colombia

ANSWERED ON THIS PAGE:

• How are medical devices classified in Colombia?
• What is the medical device registration process in Colombia?
• How long does it take to obtain INVIMA approval for medical devices?

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.

Steps to medical device registration 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.

1. Appoint an in-country representative, such as a Legal Representative, if you have no local presence in Colombia.
2. Obtain a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from your home country or an INVIMA recognized market.
3. Provide a quality system certificate, such as ISO 13485.
4. 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.
5. Submit these materials to INVIMA in Spanish and pay required application fee.
6. Once approved, INVIMA will issue a registration certificate.

View our Colombia regulatory chart for detailed information on the registration process in Colombia.

Expedited 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 6 - 8 months, to begin selling.

Why choose Emergo to assist with INVIMA device registration

Emergo has extensive experience helping medical device manufacturers register their products in various South American markets. Here’s how we can help:

• If selected as your Legal Representative, we will prepare registration materials for submission, communicate with INVIMA on your behalf, and assist with incident reporting, if requested.
• Our consultants stay up to date on the latest Colombian regulatory and quality assurance issues to ensure that you experience a smooth and efficient registration.
• We can assist you in selecting Colombian distributors based on your sales and marketing requirements.
• We can assist with registering your trademark in Colombia to protect the trademark from infringement by third parties.

From our offices in Bogotá, we can fully support your Colombian market registration effort.

Common Colombia device registration questions

Is home country approval required?
Before beginning your Colombia medical device registration process, you must secure home country approval. If you don’t have approval in your home market, you can provide a CFS/CFG from one of the following markets: Australia, Canada, Japan, Europe, or the United States.

When am I required to renew my registration in Colombia?
Registrations are valid for 10 years. Application renewals are due to INVIMA three (3) months before the expiration of your registration certificate.

What if we do not have ISO 13485 certification?
The regulation states proof of a QMS (such as ISO 13485) is required. However, you can meet this requirement another way (e.g., providing an ISO 9001 certificate or an FDA Establishment Report).