Medical Devices

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.

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

Discover the latest China life support medical device renewal trends, procurement shifts, and emerging opportunities across national and county markets.

Proposed reforms to NMPA high-end medical device regulation include faster approvals, streamlined review processes, and closer global standards alignment.

From Sept 2025, Malaysia and Singapore launch a 6-month pilot to fast track medical device registration across ASEAN. Contact Cisema today.

China GBA reimbursement frameworks have advanced to support the GBA Connect Scheme, with six cities having individually adapted policies.

NMPA’s draft guide defines medical device registration self-testing and self-checking for Class II and III devices under China’s QMS rules.

NMPA issues Medical Device Clinical Evaluation Exemption 2025 impacting international medical device registration strategies

CMDE issues rules for faster medical device reviews, supporting innovation and speeding up market access in China.

NMPA Q&A clarifies medical device site inspection compliance, guiding overseas manufacturers on release, quality, and system standards.

Malaysia and China launch a regulatory reliance pilot to streamline IVD medical device registration and accelerate cross-border market access.