India – India’s medical device regulators adopt amendment regarding cancellation and suspension of licenses
If you are a medical device manufacturer or supplier you will want to make sure to comply with the latest rules in order to...
South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
South Korea’s Ministry of Food and Drug Safety (MFDS) has announced updates to several medical device and in vitro diagnostic (IVD) regulations.
The announcements include:
...
Malaysia – MDA publishes draft guidance on notification of custom-made medical devices
The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products...
Australia – Process chart: Australia TGA regulatory approval for medical devices
Australia’s medical device market regulator has issued new guidance on digital mental health device regulation. The Therapeutic Goods Administration (TGA) published the fact sheet to inform...
China – Chinese regulators recommend clinical evaluation paths for certain medical devices
China’s Center for Medical Device Evaluation (CMDE) published several new pieces of guidance that medical device manufacturers doing business in the country should review...
Taiwan – Taiwan’s MOHW issues draft revision of UDI requirements; draft amendment of the...
Taiwan’s Ministry of Health and Welfare (MOHW) has issued Announcement No. 1111610130 and Announcement No. 1111606650 (links in Chinese) to commence the public consultations for the abolition of...
China – Medical device regulators revise Clinical Trial Quality Management Regulation and various device-specific...
Several new guidelines have been announced by medical device market regulators in China.
First, the Chinese National Medical Product Administration (NMPA) released updates regarding rules...
South Korea – MFDS rules on medical device insurance and designated non-clinical testing institutions
South Korea’s Ministry of Food and Drug Safety (MFDS) has announced updates to several medical device and in vitro diagnostic (IVD) regulations.
The announcements include:
...
Australia – Phase out of ISO 13485 certificates for IVD medical devices
The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices ends on 26...
Japan – Japan’s medical device regulators update PMD Act and the online submissions process
Japan’s medical device regulators have updated processes and procedures that manufacturers and suppliers must comply with in order to obtain Japanese market access. These...
