By Stewart Eisenhart, Emergo Group
Colombian medical device regulator INVIMA has eased some translation and grouping criteria for market registrants.
According to an INVIMA communication, Colombia registration materials pertaining to biocompatibility, risk analysis, sterilization, and clinical studies and test reports may now be submitted to reviewers in their language of origin; summaries of study descriptions, methods and conclusions must be provided in Spanish.
Second, the communication clarifies the INVIMA definition of “medical device system” as a group of products having no functionality separate from each other and are made by the same manufacturer. Such groups of products may require only a single INVIMA registration if:
- All products in the group have the same risk profile
- All products have the same indication for use
- All products have the same generic name
- A single manufacturer makes all the products in the group
Considered along with recent news that INVIMA plans to expand its oversight to more types of medical devices, these developments show that regulators are formalizing and modernizing the Colombian registration process.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.