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 Ease IVD Registration Process

Mexican medical device regulators plan to establish simplified registration for in vitro diagnostics and other low-risk products, and to exempt another 1,700 health products from medical device registration requirements altogether in an effort to increase market competition, improve public health and boost job creation.

According to officials at COFEPRIS (document in Spanish), the regulator’s moves are based on methods endorsed by the Federal Regulatory Improvement Commission (COFEMER) and recommendations from the Organization for Economic Cooperation and Development (OCDE).

Along with IVDs, COFEPRIS plans eased registration for hygienic products, healing products and dental supplies. As for the 1,700 products that will no longer require registration as medical devices, COFEPRIS will publish a list of these goods in August on its website, www.cofepris.gob.mx.

Simplified registration requirements for IVDs should boost the Mexican market’s appeal for IVD manufacturers looking to expand into new markets. Emergo Group will continue to monitor the situation for further details.