Australia – Medical device regulation changes
Changes have been made to the regulation of:
software-based medical devices
prescription spectacle lenses
medical devices containing microbial, recombinant, or animal substances
medical device...
Malaysia – MDA publishes draft guidance on notification of custom-made medical devices
The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products...
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...
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...
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...
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:
...
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...
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...
New Zealand – Guideline on the Regulation of Therapeutic Products in New Zealand
Pharmacovigilance is defined by the WHO as the science and activities relating to the
detection, assessment, understanding and prevention of adverse events or any medicinerelated...
