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...
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...
Australia – Australia unveils updated clinical evidence guidelines for medical devices and new private...
The Australian Therapeutic Goods Administration (TGA) updated several regulations, including medical devices and in vitro diagnostic (IVD) devices under Australian legislation. Changes involve clinical...
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 – NMPA rules on medical device naming, QMS inspections and industry standards
China’s National Medical Products Administration (NMPA) published a number of guidance documents pertaining to medical devices and IVD regulations, including medical device naming guidelines,...
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...
Australia – Australia updates guidance on implantable medical devices, required six-monthly report
Australia’s Therapeutic Goods Administration has issued a number of new pieces of guidance that medical device manufacturers doing business in the country should review...
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...
