News

The 26 new medical device standards cover orthopedic implants, IVDs, active devices, and software risk management.

China’s NMPA has opened consultation on a draft mandatory toothpaste safety standard that could tighten product requirements.

China's HAF003 reform and participation in the "Tripling Nuclear Energy Declaration" signals stricter compliance and new opportunities.

China’s NMPA mandates full UDI coverage for all medical devices by 2029, linking compliance to registration, reimbursement, and market access.

China’s NMPA issues new guidance on clinical trial protocol pre-review for innovative devices, impacting overseas fast-track approvals.

China clarifies GACC Order 280 rules for imported food registration and customs declarations ahead of June 2026 enforcement.

China NMPA adds four new cosmetic testing methods effective July 2026, impacting compliance and safety assessment strategies.

China’s NMPA updates cosmetics testing methods, adding CBD detection and tighter impurity controls impacting global compliance.

China releases guiding principles for benefit-risk assessment using multi-regional clinical trial data to support global drug development.

China releases new subject selection guidance for anti-tumor drug bioequivalence and pharmacokinetic studies.

China’s CCC mark pilot reform requires traceability QR codes for power banks, electric bicycles, and gas appliances.

SAMR introduce stricter recall and compliance requirements for enterprises involved in cross-border e-commerce retail imported food.

China NMPA’s 2025 report highlights growth in medical device approvals, including advanced imported devices.

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.