Regulatory News from Across Asia-Pacific

Discover the eight efficacy categories, revised filing requirements, and key compliance deadlines that toothpaste manufacturers and importers must meet.

See how China’s new battery registration guidance affects technical documentation, supplier coordination, and NMPA review of active implantable medical devices.

China's CMDE guidance defines clinical trial and registration considerations for implantable BCI devices, including patient selection, endpoints, and post-market follow-up.

Learn how China’s proposed measures could affect market exclusivity for pediatric and rare disease drugs, including eligibility, filing timelines, and supply obligations.

Indonesia has updated the categories, product types and risk classes used for IVD medical devices. Learn what this means for new and existing authorizations.

The announcement sets tighter thresholds, testing mandates, and exemption pathways for foreign brands selling cosmetics and toothpaste in China.

New medical device GMP inspection guidelines introduce revised inspection criteria and risk classifications.

New Indonesian guidelines impact SaMD, SiMD, and AI medical devices, introducing updated documentation and clinical validation rules.

China’s 2026–2030 pharmaceutical plan sets ambitious targets to turn its biopharma sector into a global innovation engine, reshaping international competition, licensing, and regulation.

Plan ahead for Malaysia NPRA’s 2026 year-end payment closure, featuring key deadlines for QUEST3+ online transactions and the Revenue Counter.

China’s latest policy sets new requirements for hospital medicine catalogs, prescribing practices, clinical evaluation, and performance-linked funding

Vietnam’s Decision No. 3046/QĐ-BYT expands CSDT appraisal capacity for medical devices.

Learn how Vietnam’s Apostille Decree may affect medical device registration and cosmetic product notification, including CFS, LOA, and document legalization requirements.

Discover key changes in China’s 50 new national food safety standards and learn how foreign food manufacturers can prepare for upcoming compliance deadlines.

New requirements could affect how injectable devices, including dermal fillers, are supplied in Hong Kong’s private healthcare sector.

China’s new Healthcare Security Law affects medical device reimbursement, health economic evidence, payment models, and digital traceability from 2027.

BPJPH Regulation No. 4 of 2026 introduces pre-shipment halal verification and LPPH reports for imported goods starting September 2026.

New CVDA guidelines provide detailed guidance for online veterinary drug sellers and platforms, covering licensing, imports, labeling, prescriptions, and traceability.

China’s NMPA has released YY/T 2029–2026, establishing the world's first AI-BCI EEG dataset quality standard for medical devices ahead of its September 2027 enforcement.

China's NMPA has established two supplementary testing methods to detect prohibited substances in cosmetics with high-sensitivity liquid chromatography.