News

China’s NMPA releases 2025 annual report on medical device standardization, highlighting growth, innovation, and international alignment.

Malaysia’s NPRA introduces reliance and priority review pathways for additional indications of registered innovator drugs.

The draft 2026 catalogue defines which Class III medical devices would require clinical trial approval before trial initiation.

Malaysia’s MDA withdraws personal use medical device importation Guidance Document, directing stakeholders to updated exemption requirements.

Indonesia’s BPOM has strengthened clinical trial approval procedures and introduced detailed requirements for cosmetic clinical trials.

Malaysia’s NPRA mandates DEG and EG testing for high-risk oral liquid products, with mandatory compliance starting April 1, 2027.

Vietnam’s MoH recently published Circular drops several healthcare advertising regulations and streamlines requirements for many categories.

Malaysia’s NPRA issues Directive No. 7 of 2026 mandating the Malaysian Guideline for GCP 5th Edition for clinical trials.

Malaysia’s MDA and Thailand’s FDA launch a medical device reliance pilot to accelerate market access for Class B–D devices.

Vietnam’s draft cosmetic management decree would replace existing rules and strengthen post-market controls for cosmetic companies.

Malaysia clarifies that medical device tenders count as market placement, triggering licensing and compliance requirements.

Malaysia’s MDA will regulate aesthetic and cosmetic medical devices under the Medical Device (Designated Medical Devices) Order 2026.

NPRA Circular No. 1/2026 updates Malaysia’s cosmetic ingredient annexes to align with the ASEAN Cosmetic Directive

Circular No. 1/2026 clarifies regulatory requirements for medical device procurement tenders, such as licensing and GDPMD compliance.

Learn the registration requirements, scope, and compliance steps as Hong Kong regulates medical gases as pharmaceutical products.

China’s NMPA is incorporating 18 revised cosmetics standards into the Safety and Technical Standards for Cosmetics.

China’s NMPA formally includes black ginseng extract, hydrolyzed sodium hyaluronate zinc, and galactomannan in the IECIC.

China’s National Medical Products Administration has issued its 2026 medical device standards plan, introducing 80+ new and revised standards

China’s CMDE announced revisions to the registration review guideline for aesthetic sodium hyaluronate injectable fillers.

China’s CDE released three 2026 trial guidelines on Phase III design for chronic insomnia, neuropathic pain, and depressive disorders.