Medical Device Blog – QA & Regulatory Updates from Emergo Group

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 Expands Equivalency to Devices Registered in Japan

Mexican medical device regulator COFEPRIS has extended its Equivalency Agreement granting expedited reviews for some medical devices registered in the US or Canada to some devices approved or certified for sale in Japan.

COFEPRIS equivalence will apply to devices classified as Class II, III or IV in Japan; products registered as Class I devices in Japan must still go through the standard registration process in Mexico.

Manufacturers of qualifying devices must have either approval issued by Japan’s Ministry of Health, Labor and Welfare (MHLW) or their certificates issued by a Registered Certification Body in Japan.

Some of the documents that manufacturers must also provide in order to qualify for expedited review in Mexico are:

Operating license
Notification of Exportation
Original Certificate of Free Sale
Original Letter of Representation
Labels and Instructions for Use

The expanded Equivalency Agreement will go into effect February 24, 2012. Interest in the Mexican market has already increased over the past year due to expedited review options for manufacturers registered in the US and Canada; similar interest from medical device companies registered in Japan will no doubt also grow once the new agreement is implemented.