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 – TGA publishes latest medical device application processing times
Australia’s Therapeutic Goods Administration (TGA) has published Medical device application processing times, which provides details on its latest timelines for medical device and in vitro diagnostic (IVD)...
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...
India – India’s DCGI adds more medical device testing laboratories
Helping to make getting your medical device or in vitro diagnostic (IVD) device testing done a little bit easier, the Drug Controller General of...
India – India issues new draft IVD rules and updated classifications for rehab devices
Indian medical device market regulators have published new draft in vitro diagnostic device rules and made them available for industry comment. In addition, Indian...
Singapore – HSA to commence Phase I implementation of UDI labeling in November 2022
Singapore’s medical device market regulator, the Health Services Authority (HSA), has issued a notification indicating that Phase I implementation of its Unique Device Identification...
