Malaysia 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…

Monday, 16, March, 2026 / Published in Malaysia, News, Pharma & Biotech

Malaysia Introduces Reliance and Priority Review Mechanisms for Additional Drug Indication Applications

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has introduced new regulatory mechanisms intended to streamline the review of additional indication applications…

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…

Tuesday, 10, March, 2026 / Published in Malaysia, News, Pharma & Biotech

Malaysia Mandates Testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in High-Risk Oral Liquid Products

On February 10, 2026, the National Pharmaceutical Regulatory Agency (NPRA), under the Ministry of Health Malaysia, issued “Directive No. 8…

Tuesday, 10, March, 2026 / Published in Malaysia, News, Pharma & Biotech

Malaysia Mandates GCP 5th Edition for Clinical Trials Under New NPRA Directive

On January 29, 2026, the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health Malaysia issued “Directive No. 7…

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…

Thursday, 5, March, 2026 / Published in Cosmetics & Ingredients, Malaysia, News

Malaysia NPRA Updates Cosmetic Ingredient Lists Following ASEAN Cosmetic Directive Updates

On February 17, 2026, the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health Malaysia issued “Circular No. 1/2026”…

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