TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – Conformity assessment certificates, changes to requirements for certain medical devices

On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2020(link is external). This means that...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Convergence: First-year experience with Japan’s amended medical device rules

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is providing priority review for certain innovative medical devices and has implemented a post approval change management...
Singapore HSA revises guidance and technical documents

Singapore – Singapore HSA recommends cybersecurity protections against BrakTooth for Bluetooth medical devices

The Health Sciences Authority (HSA), Singapore’s medical device market regulator, has issued recommendations for some medical devices utilizing Bluetooth connectivity to protect against new...
Singapore HSA revises guidance and technical documents

Singapore – Singapore HSA finalizes Unique Device Identification (UDI) requirements for medical devices

Singapore’s medical device market regulator, the Health Sciences Authority (HSA), has published final guidance for Unique Device Identification (UDI) regulations covering medical devices sold...
Hong Kong regulator will continue to recognize South Korean approvals

China – Chinese regulators revise drug-device combination product registration requirements

China’s National Medical Products Administration (NMPA) has updated registration requirements and processes pertaining to combination products that include drug and medical device (drug-device) components. Determining...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – South Korea MFDS plans several medical device regulatory updates for 2022

The Ministry of Food and Drug Safety (MFDS), South Korea’s medical device market regulator, plans to roll out several amendments to the country’s Medical Devices...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Is my software regulated?

Flowcharts showing which software products are regulated as a medical device, and those that are not...
TGA Updates Guidance on the Testing of Biological Medicines

Australia – TGA international engagement strategy 2021-2025

The Therapeutic Goods Administration (TGA), as part of the Australian Department of Health, supports the Department's strategic priorities for an affordable, accessible, efficient and...
The Cosmetic Hygiene And Safety Act Reshaped Taiwan's Cosmetic Regulation

Taiwan – Final exemption list, cybersecurity guidelines, COVID-19 measures and more (Update)

Final list of medical devices exempt from QMS certification requirements now available In a significant development, the Taiwan Food and Drug Administration (TFDA) has published...
Singapore HSA revises guidance and technical documents

Singapore – Singapore HSA holds consultation on SaMD classification draft guidance

Singapore’s Health Sciences Authority (HSA) has initiated a public consultation on the draft Regulatory Guidelines for Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical...

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