As PBM noted in a July news brief, China’s revised Regulations on the Supervision and Administration of Medical Devices went into force on June 1, 2014. On August 1, the China Food and Drug Administration (CFDA) released additional detailed information on implementing the revised device regulations. These measures will go into effect October 1, 2014.
The CFDA has released five separate announcements:
- Administrative Measures for Medical Device Registration
- Administrative Measures for the Registration of In Vitro Diagnostic Reagents
- Administrative Rules for the Instructions and Labels of Medical Devices
- Administrative Measures for the Supervision of Medical Device Manufacturing
- Administrative Measures for the Supervision of Distribution of Medical Devices
These announcements detail the processes and requirements for product registration and registration changes, product testing, clinical evaluation, product classification, labeling, record management, production management, quality assurance, re-registration and legal liability.
PBM strongly recommends that all companies manufacturing and/or selling medical devices in China make sure that they understand these new detailed regulatory announcements. This is especially important for high risk medical devices and IVDs, which now require local clinical trials for approval.
PBM has translated two of the new Chinese regulations into English. Click here to read.