Regulatory News from Across Asia-Pacific

NMPA issues draft changes to China’s IVD Classification Catalogue, adding new risk classes and technology platforms.

Indonesia revises medical device and IVD registration timelines under Permenkes 11/2025, extending approval timelines.

Taiwan’s Ministry of Health and Welfare tightens cosmetic ingredient rules for hair dyes, children’s cosmetics, and oral care products.

NMPA outlines cosmetics regulation reforms, aiming to expand non-animal testing, streamline registration, and drive ingredient innovation.

The new GMP for medical devices, effective Nov 1 2026, introduces stricter quality, personnel, and supplier controls.

Malaysia’s MDA introduces a two-year validity for Product Classification Letters from May 1, 2025 – see timelines and requirements.

Rising Class III medical device registrations in China during Q1–Q3 2025 signal opportunities for foreign manufacturers of advanced devices.

China’s 2024 NIFDC Cosmetics Review Report showcases soaring registrations and key opportunities for global beauty brands.

China's GCP for Drugs (2025) Draft Revision proposes major updates on data governance, sponsor accountability, ethics, and technology use.

China's NIFDC has opened consultation on six draft cosmetic standards covering safety assessment and ingredient management - Comments due: 7 November 2025.

Learn about the 2025 China Energy Label (CEL) update, covering 38 product categories and new implementation rules.

Malaysia’s MDA has increased Class A medical device registration fees effective January 2026 — impacting all new and renewal submissions.

Malaysia MDA's Draft 7th Edition labelling requirements introduce broader e-labelling requirements and stronger accessibility standards.

Latest NMPA drafts propose expanding Unique Device Identification (UDI) rules to nearly all medical devices by 2029.

China’s CDE has launched consultations on six key updates to drug R&D communication in the 2025 draft measures.

Taiwan’s Safety Monitoring & Management Measures improve post-market oversight, advancing the dual-track regenerative medicine framework.

SAMR mandates hazardous substance rules for electrical and electronic products, raising compliance requirements for manufacturers.

Explore China’s latest CDE draft guidelines on oligonucleotide drugs, advanced therapies, & biologics — key insights for regulatory planning.

Get a summary of three new CDE draft regulatory guidelines that cover mRNA vaccine research, DSUR reporting, and CAR-T product instructions.

The Philippines FDA has extended the suspension of the new fees to allow more time for stakeholder consultations and review.