Columbia

1. Authorities

In Colombia, medical devices and in vitro diagnostic devices are regulated by the National Institute for Medications and Food Surveillance (INVIMA).

2. Relevant Regulations

Regulatory framework: Legislative Decree 582/17 and IVD Directive

Classification Guide: MD is divided into Class I, IIa, IIb and III, and IVD is divided into Class I, II and III. The classification rules followed are Decree 4725/2005

3. Time estimation

4 months

4. Local Representatives

A local representative is required to enter the Colombian market. The main responsibilities of the local representative in Colombia are to respond to the requirements of the competent authorities, provide all necessary information and documents to the competent authorities, complete the entire registration process and communicate with the authorities in a timely manner; cooperate with the competent authorities, take any preventive or corrective measures, and promptly report adverse events after the product is put on the market to the authorities and manufacturers.

5. Successful Cases

More than 3+ registered cases