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...
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:
...
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...
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 – Medical devices vigilance program pilot
The TGA is commencing a new Medical Devices Vigilance Program (MDVP). The MDVP will begin as a 12-month pilot. The pilot is designed to...
Australia – New guidance published on manufacturer evidence for IVD medical devices
We no longer accept ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, except if the manufacturer made a...
Malaysia – MDA publishes draft guidance on notification of custom-made medical devices
The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products...
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...
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...
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...
