Jan 22, 2013
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:
For medical devices now exempt from PMDA stability testing requirements, manufacturers must still provide in their Japan medical device registration applications descriptions of their products’ shelf lives in cases where a shelf life is less than three years. All manufacturers and sponsors should also be prepared to verify stability of their devices and maintain pertinent documentation in case such data is requested by regulators or quality system auditors.
In instances where a manufacturer of a device already registered with the PMDA changes its product’s shelf life, that manufacturer should submit a Minor Change Application.
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 tr
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.
The PMDA has just recently released a spreadsheet enumerating the pre-market certificates issued by each of the 12 Registered Certification Bodies (RCBs) sanctioned under the Pharmaceutical Affairs La