Medical Devices

Manufacturers seeking MRI registration in China must meet expanded technical, software, and validation requirements.

China's new BCI medical device guidance establishes classification and naming principles, giving manufacturers a clearer pathway to NMPA registration.

New Hainan MPA guidance clarifies how Lecheng real-world evidence can support imported product registration, labeling updates, and post-approval activities

MDA will issue only electronic establishment licenses, affecting medical device manufacturers, importers, and distributors.

Indonesia removes IDAK renewals, mandates SDAK and IPAK transitions, and shortens correction timelines under risk-based licensing.

New MDA guidance introduces a risk-based framework for managing post-registration medical device changes, including software updates and SaMD.

Applicable for new registrations, renewals, and variations, the Standardized Medical Device Specification Template improves data consistency and regulatory review efficiency.

The full implementation of the reliance program creates new opportunities for manufacturers to accelerate regional market entry by strategically leveraging approvals across both jurisdictions.

Malaysia’s latest regulatory updates expand electronic labelling for pharmaceuticals and simplify medical device label requirements for foreign manufacturers.

Summary of 2025 MFDS trends covering medical device approvals, import dynamics, and the shift toward AI and software-based regulation.

China’s SAMR has released draft advertising review measures that would increase oversight of livestreaming and digital marketing while streamlining certain compliance requirements for regulated products.

The updated GN-00 guidance reduces classification uncertainty and creates clearer MDACS pathways for injectable dermal fillers in Hong Kong.