The Cosmetic Hygiene And Safety Act Reshaped Taiwan's Cosmetic Regulation

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...
Process chart: Medical device & IVD registration requirements in Malaysia

Malaysia – MDA publishes draft guidance on notification of custom-made medical devices

The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products...
TGA Updates Guidance on the Testing of Biological Medicines

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...
Seegene's COVID-19 test authorized for emergency use in Korea

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 revises guidance and technical documents

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...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

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...
Seegene's COVID-19 test authorized for emergency use in Korea

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 Seeks Feedback on Mandatory use of QR Codes on API Packaging

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...

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...

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