Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japan’s MHLW updates medical device program display code and labeling laws

Japan’s medical device regulators have updated regulations and implementation guidelines for enforcement of the PMD Act and bar code labeling laws. Manufacturers should become...

Australia – Update: Medical device UDI implementation, Essential Principles guidance

The Therapeutic Goods Administration (TGA), Australia’s medical device market regulatory entity, has issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles compliance...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – Updates: Innovative device designations, IVD Act enforcement

Regulators in South Korea have issued two recent revisions to medical device and in vitro diagnostic (IVD) registration and approval requirements of note for...
India Seeks Feedback on Mandatory use of QR Codes on API Packaging

India – Indian regulators add to list of medical device testing laboratories

Indian regulators have updated their list of organizations qualifying as Medical Device Testing Laboratories (MDTLs), adding three entities to perform testing and evaluation of...

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

Japan – Japan updates guidance on QMS Conformity Survey applications

Japan’s Ministry of Health, Labour and Welfare (MHLW) has updated its guidance on documents that medical device market registrants must submit when applying for...
Singapore HSA revises guidance and technical documents

Singapore – Singapore adds HIBCC to list of UDI issuing agents

Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has announced that a new designated issuing agency (IA) has been added to its...

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