Jun 13, 2011
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.
As you may know, medical devices in Japan are classified as follows:
Japan’s Ministry of Health, Labour and Welfare has exempted stability test report requirements for some medical devices submitted to the Pharmaceutical and Medical Devices Agency (PMDA) for registration.
Stability testing remains a requirement, however, for medical devices using new or innovative materials with little or no stability data, or that are structurally different enough from their predicate devices to require verification of stability. Testing requirements also remain for the following device types:
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.