By Stewart Eisenhart, Emergo Group
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.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.