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 – 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...
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...
Taiwan – Taiwan’s MOHW issues draft revision of UDI requirements; draft amendment of the...
Taiwan’s Ministry of Health and Welfare (MOHW) has issued Announcement No. 1111610130 and Announcement No. 1111606650 (links in Chinese) to commence the public consultations for the abolition of...
Malaysia – MDA publishes draft guidance on notification of custom-made medical devices
The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products...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 – TGA set to accept medical device assessments from Singapore’s HSA
The Therapeutic Goods Administration (TGA), Australia’s medical device market regulator, has announced that it now recognizes Singapore’s Health Sciences Authority (HSA) as a comparable...
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...
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...
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...
