Medical Devices

Malaysia’s MDA has issued major updates affecting medical device classification, special access exemptions, and management of obsolete and discontinued devices under the Medical Device Act 2012

New measures define vigilance management, inspections, PSURs, trend reporting, and reporting requirements in 17 pilot regions

China’s NMPA released a AI roadmap for smarter supervision across drugs, medical devices, and cosmetics regulation, covering AI-supported review, inspections, traceability, risk monitoring, and digital governance through 2035.

Hong Kong classifies classifcation of injectable products, 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.