Medical Devices

Hong Kong confirms injectable products are generally classified as pharmaceutical products under Cap. 138, impacting medical aesthetics and borderline products

CMDE maps 275 guideline updates, tightening requirements and giving manufacturers early visibility for planning and compliance.

China’s MIIT and nine ministries introduce a new AI ethics review and services framework establishing tiered oversight, compliance obligations, and governance pathways for AI activities in China.

China issues new guidelines on medical device adverse event risk evaluation and periodic report review, tightening post-market surveillance requirements

China’s CMDE releases a new IVUS registration review guideline, defining technical, clinical, and testing requirements for NMPA medical device registration

Malaysia’s MDA publishes the 7th edition of guidance on medical device labelling, with new e-labelling, e-IFU, and accessibility requirements

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

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 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.

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