Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Mexico to Introduce New Class for Low-risk Medical Devices

Mexican medical device regulator COFEPRIS plans to establish a new device category, Class 1A, for nearly 100 products currently exempt from registration requirements.

Items on the list include tongue depressors, nasal aspirators, umbilical tapes and clamps, gauze, compression bandage systems and bandages.

According to our sources in Mexico, implementation of the new requirement will happen sometime in the next three months, and COFEPRIS has yet to issue details of how affected manufacturers will have to register their devices in order to comply with Class 1A rules.

We will keep you informed as we learn more about this development.