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...
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 – 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 – 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...
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 – 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...
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...
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...
Australia – Update: TGA defines which digital mental health software it regulates
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...
Singapore – Singapore issues new guidance for software as a medical device
As software has begun to have an increasingly important role in many medical devices that rely on it for safe and effective function, Singapore’s...
