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...
Australian regulatory action on breast implants and breast tissue expanders

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Malaysia – MDA publishes draft guidance on notification of custom-made medical devices

The Malaysian Medical Device Authority (MDA) has published draft guidance that provides requirements and a notification process for manufacturers to follow for custom products...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...

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