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...
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 – 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...
China – Update: Class I medical device filing rules, UDI standards
China’s National Medical Products Administration (NMPA) has amended guidance on record filing requirements for low-risk Class I medical devices in order to reflect broader...
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...
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...
South Korea – South Korea rules on emergency production and distribution of medical products
Regulators in South Korea have introduced policies and procedures ordering the production and distribution of medical products during a public health emergency (PHE).
The Ministry...
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 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...
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...
