Global Medical Device Updates
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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.
Markets: Japan, MexicoTags: COFEPRIS, equivalency agreement, Japan, medical device, Mexico, PMDA
Author: Stewart EisenhartDate: January 26, 2012
JFMDA Pushing for More Flexible Accreditation System in Japan
The Japan Federation of Medical Device Associations (JFMDA) has filed a petition with the country’s Ministry of Health, Labour and Welfare as well as the Pharmaceutical and Medical Devices Agency (PMDA) arguing for more flexible accreditation requirements for foreign device manufacturers that move factories or change names due to mergers or acquisitions.
According to Medtechinsider.com, current law requires foreign manufacturers that relocate factories or change corporate identities to resubmit requests for accreditation. Until those firms are reaccredited, they cannot export products to Japan.
The JMDA has argued that these firms should only have to register their company names, locations and the names of their representatives in order to obtain reaccreditation. Currently, manufacturers must undergo new factory inspections including quality system audits as part of the Japanese reaccreditation process.
Easing the reaccreditation process for foreign medical device manufacturers would provide a more stable supply of medical devices in Japan, contends the JMDA. The association filed the petition as the Japanese government considers how to amend its Pharmaceutical Affairs Law in 2012.
Given that Japan is both one of the largest and most complex medical device markets, any effort to make this market more accessible without compromising safety warrants serious consideration.
Japanese Trade Groups Urge Creation of Pan-Asian MedTech Community
The Japan Federation of Medical Device Associations (JFMDA) and the Medical Engineering Technology Industrial Strategy consortium (METIS), Japan’s two largest medical device and technology trade associations, have jointly advocated that their government establish an Asian medical technology community in order to maintain Japanese regional competitiveness, according to the blog Medtechinsider.com.
The two groups have also called for greater collaboration between industry, governmental and academic entities to improve medical technology market research in countries such as China and India; shorter review times by the Pharmaceutical and Medical Devices Agency (PMDA) in Japan as well as more standardized device review systems throughout Asia; greater funding for joint clinical trial endeavors between Japan and other Asian countries; and reduced trade barriers throughout the continent.
The JMDAS and METIS have advanced these arguments following the Japanese government’s formation of a strategic council in early 2011 in order to promote medical device and technology innovation.
