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Malaysia – MDA publishes draft guidance on notification of custom-made medical devices
The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products...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...
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 – 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...
India – Indian regulators add to list of medical device testing laboratories
Indian regulators have updated their list of organizations qualifying as Medical Device Testing Laboratories (MDTLs), adding three entities to perform testing and evaluation of...
