Medical Devices Archive

Warehouse workers wearing high-visibility safety vests review inventory documents beside stacked boxes labeled “medical supplies” in a logistics facility, illustrating supply chain management, product documentation, and regulatory compliance processes relevant to market access and product distribution in China and Asia-Pacific markets.

Thursday, 2, April, 2026 / Published in Malaysia, Medical Devices, News

Malaysia MDA Tightens Oversight of Medical Device Procurement with MDA Circular No. 1/2026

On March 5, 2026, the Medical Device Authority (MDA) of Malaysia announced the implementation of “Medical Device Authority (PBPP) Circular…

Two professionals in a modern office review documentation for a HealthScreen glucose monitor while examining a computer display showing a product label with model number, barcode, and QR code. One person points to the code on the screen as the other reads the instruction leaflet beside a boxed device package. The scene suggests product labeling verification, documentation review, and regulatory compliance processes relevant to medical device product registration and market access in China and the Asia-Pacific region.

Wednesday, 1, April, 2026 / Published in Malaysia, Medical Devices, News

Malaysia Introduces New e-IFU & Digital Labelling Guidance for Medical Devices

Malaysia’s Medical Device Authority (MDA) has published the updated guidance document “MDA/GD/0026 – Requirements for Labelling of Medical Devices (7th…

Tuesday, 10, March, 2026 / Published in Malaysia, Medical Devices, News

Malaysia Withdraws MDA Guidance on Importation of Medical Devices for Personal Use

On February 16, 2026, the Medical Device Authority (MDA) announced the withdrawal of “Guidance Document MDA/GD/0066 – Importation of Medical…

Monday, 9, March, 2026 / Published in Malaysia, Medical Devices, News, Thailand

Malaysia–Thailand Regulatory Reliance Pilot Opens Faster Pathway for Medical Device Approvals

On December 4, 2025, the Medical Device Authority (MDA) of Malaysia and the Thai Food and Drug Administration (Thai FDA)…

Thursday, 5, March, 2026 / Published in Malaysia, Medical Devices, News

Malaysia MDA Strengthens Oversight of Medical Device Procurement Supply Chain

On January 28, 2026, the Medical Device Authority (MDA) implemented “Circular Letter No. 1/2026”, establishing updated regulatory requirements governing medical…

Thursday, 5, March, 2026 / Published in Malaysia, Medical Devices, News

Malaysia Expands Medical Device Regulation to Aesthetic Treatment Technologies

On February 25, 2026, the Medical Device Authority (MDA) of Malaysia announced the gazettement of the “Medical Device (Designated Medical…

Wednesday, 19, November, 2025 / Published in Malaysia, Medical Devices, News

Malaysia MDA Introduces Two-Year Validity for Product Classification Letters

Malaysia’s Medical Device Authority (MDA) announced on November 11 2025, that Product Classification Letters will transition to a two-year validity…

Friday, 24, October, 2025 / Published in Malaysia, Medical Devices, News

Malaysia MDA Announces New Registration Fees for Class A Medical Devices

The Medical Device Authority (MDA) of Malaysia has announced revisions to Class A medical devices registration fees under the Medical…

Thursday, 23, October, 2025 / Published in IVDs, Malaysia, Medical Devices, News

Malaysia MDA Launches Public Consultation on Medical Device Labelling: Expanding e-Labelling and Accessibility Standards

On 16 October 2025, the Medical Device Authority (MDA) released the Draft 7th Edition of Guidance Document MDA/GD/0026 – Requirements…

Malaysia Singapore Medical Device Regulatory Reliance

Monday, 25, August, 2025 / Published in Malaysia, Medical Devices, Medical Devices, News, Singapore

Malaysia-Singapore Regulatory Reliance Pilot Speeds Medical Device Registration

Malaysia and Singapore regulatory reliance pilot, starting 1 September 2025, introduces a six-month program to simplify medical device registration, helping…

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