Hong Kong regulator will continue to recognize South Korean approvals

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...
The Cosmetic Hygiene And Safety Act Reshaped Taiwan's Cosmetic Regulation

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...
Home-grown colorectal cancer drug approved in China

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...
Seegene's COVID-19 test authorized for emergency use in Korea

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...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

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...

China – Update: Class I medical device filing rules, UDI standards

China’s National Medical Products Administration (NMPA) has amended guidance on record filing requirements for low-risk Class I medical devices in order to reflect broader...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – South Korea updates regulations on medical device codes and classification

The Ministry of Food and Drug Safety (MFDS), South Korea’s medical device market regulator, issued a draft revision to Regulations on Medical Device Codes...

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