Introduction

The National Institute for Food and Drug Surveillance (Invima) has presented a new guide for importers and manufacturers of medical devices and in vitro diagnostic reagents to file requests for certification or recertification visits.

Application Requirements

Establishments and/or individuals intending to import, manufacture, or expand the manufacturing line of medical devices and in vitro diagnostic reagents must submit the application as outlined in the guide.

Importance of Compliance

It is essential to note that current health regulations set forth the requirements that manufacturers and importers of medical devices must adhere to, ensuring that these products meet quality and safety standards.