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...
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...
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...
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 – 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 – Phase out of ISO 13485 certificates for IVD medical devices
The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for in vitro diagnostic (IVD) medical devices ends on 26...
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)...
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...
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...
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...
