Newsletter

MALAYSIA : Updated in Harmonised Borderline Products in ASEAN (MDA/GD/0063) and Harmonised Classification of Medical Devices in ASEAN (MDA/GD/0062) – June/July 2025

MALAYSIA : Updated in Harmonised Borderline Products in ASEAN (MDA/GD/0063) and Harmonised Classification of Medical Devices in ASEAN (MDA/GD/0062) – June/July 2025

  • 2025-07-10 10:02:10

The Malaysia Medical Device Authority (MDA) has published the latest edition of Harmonised Borderline Products in ASEAN which provides an updated classifications list for products that may fall under medical device regulations across ASEAN member states. This update helps establishments to determine their products classification (medical device or non-medical device).

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Australia: Understanding TGA's New Requirements for Medical Devices Containing Medicinal, Microbial, Recombinant, or Animal-Origin Substances – April/May 2025

Australia: Understanding TGA's New Requirements for Medical Devices Containing Medicinal, Microbial, Recombinant, or Animal-Origin Substances – April/May 2025

  • 2025-04-24 03:49:40

The Therapeutic Goods Administration (TGA) has introduced updated regulatory requirements, effective from July 1, 2024, for medical devices containing medicinal, microbial, recombinant, or animal-origin substances. These changes aim to streamline classification rules, update labelling requirements, and broaden the recognition of international regulatory approvals, thereby reducing unnecessary regulatory burdens while maintaining safety standards.

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China: Announcement of the National Medical Products Administration on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices by Domestic Enterprises in China (No. 30 of 2025) – April/May 2025

China: Announcement of the National Medical Products Administration on Further Adjusting and Optimizing Matters Related to the Production of Imported Medical Devices by Domestic Enterprises in China (No. 30 of 2025) – April/May 2025

  • 2025-04-24 07:49:13

The National Medical Products Administration has further adjusted and optimized certain provisions of the Announcement on Matters Concerning the Production of Imported Medical Device Products by Domestic Enterprises in China, originally issued in September 2020.

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Australia: TGA Updates Application Audit Rules for Medical Devices and IVDs: What Manufacturers Need to Know – February/March 2025

Australia: TGA Updates Application Audit Rules for Medical Devices and IVDs: What Manufacturers Need to Know – February/March 2025

  • 2025-02-21 05:10:50

The Therapeutic Goods Administration (TGA) has updated its application audit guidance for medical devices and in-vitro diagnostics (IVDs), to streamline regulatory processes and focus on high-risk devices. Additionally, the transition from the EU In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) introduces stricter requirements and extended transition periods for compliance. Medical device manufacturers must ensure thorough documentation and timely submissions to meet these evolving standards.

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Thai FDA - Updated Advertising License Regulations for Medical Devices

Thai FDA - Updated Advertising License Regulations for Medical Devices

  • 2025-02-20 11:17:07

From January 4, 2025, onwards, Thai FDA has tightened medical device advertising rules to prevent misleading claims. Advertisements must align with approved product information, specify target audiences, and include required disclaimers. Stricter enforcement measures target misleads advertising, especially for dermal fillers. Likewise Consumers shall verify approved products on the Thai FDA's website, updated on a weekly bases.

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Thailand: Thai FDA Introduced Priority Track for Non-Communicable Disease (NCDs) Medical Devices – February/March 2025

Thailand: Thai FDA Introduced Priority Track for Non-Communicable Disease (NCDs) Medical Devices – February/March 2025

  • 2025-02-20 11:06:06

The Thai FDA has launched a priority track for 6 types of medical devices targeting Non-Communicable Diseases (NCDs), enabling faster approval for essential healthcare solutions. This initiative is designed to ensure quicker access to vital healthcare solutions, providing medical device companies with faster market entry for devices targeting public health challenges.

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