Colombia has about 50 million residents and is a very strong market for foreign medical device manufacturers. Interested in entering this market? This article explains the process of obtaining regulatory approval from INVIMA, the country's regulator. Topics covered include regulations, device classes, appointing an independent representative, review times for the controlled and non-controlled products, and registration timelines.

Steps to register your medical device in Colombia

1. 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.

2. If you have no local presence in Colombia, then you must appoint an in-country representative (aka “legal representative” in Colombia). If you appoint an importer of record they may list themselves as the owner of the registration. If you appoint a legal representative, they will request Power of Attorney to manage your registration process, but you will retain ownership.

3. Obtain a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) from your home country or an INVIMA recognized market (Australia, Canada, Europe, Japan or the US).

4. Provide quality system certificate, e.g. ISO 13485.

5. Provide product information and 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.

6. Your legal representative will submit your application dossier to INVIMA in Spanish and will pay the required application fee.

7. Once approved, INVIMA will issue a registration certificate (aka “registro sanitario” by INVIMA) valid for ten (10) years and will be held by your legal representative or importer of record in Colombia. By default, INVIMA automatically approves Class I and IIa applications, so you may begin importing and selling immediately. However, INVIMA will still review the application and may request additional information which must be provided within 30 working days. Once approved, INVIMA will issue your registration certificate. For Class IIb and Class III devices, INVIMA will take 3-4 months to review your registration application and may ask follow-up questions or request additional information. If all requirements are met, INVIMA will issue your certificate.

8. Once approved, INVIMA will issue the registration certificate. Your registration certificate will be held by your legal representative in Colombia.

9. You may begin importing, marketing and selling your device in Colombia. Registrations are valid for 10 years. Application renewals are due to INVIMA three (3) months before the expiration of your registration certificate.

Notes:

Irrespective of whether the registration is submitted via a legal representative or not, the manufacturer must appoint an importer of record and a licensed storage facility in the registration. Registrations will not be accepted without a valid importer or storage facility named.The time frames shown above are typical for the majority of medical device submissions but assume that your device does not contain animal tissue, medicinal substances or employ entirely novel technology. Your length of approval will depend on the quality and completeness of your technical documentation and how much time you take to address additional information requests from INVIMA after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE. Registrations remain valid for the time specified as long as you do not make changes to the device, intended use or indications for use. Renewal documents are due to INVIMA three months prior to the expiration of the current registration certificate. We recommend starting the re-registration process no later than the time period specified above. However, please consult with your local regulatory expert well before this suggested time to avoid any lapse in your registration. More information at www.bioaccessla.com.

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About Julio G. Martinez-Clark: Julio is CEO of bioaccess.™ —US-based contract research organization (CRO), regulatory, and market access consulting company that delivers a full spectrum of offerings from bench to commercialization so that foreign manufacturers of regulated products can have long-term success in Colombia and the rest of Latin America. Learn more.