Medical Devices

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

Vietnam’s MoH recently published Circular drops several healthcare advertising regulations and streamlines requirements for many categories.

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.

China radio frequency beauty devices have new technical review guidelines issued to ensure that products are safe and effective

China medical device industry standards March 2023 update covers 20 standards released by the NMPA for manufacturers to comply with.

Coronavirus product manual changes are required by the NMPA in China. Notice No. 349 (2023) outlines important modifications for Coronavirus nucleic acids, antigens, and antibodies detection reagents.

China medical device registrations 2023 annual report has been issued by the NMPA.

China’s NMPA has released updated inspection principles for medical device clinical trials, effective May 1, 2025. Discover key changes, risk categories, and compliance strategies.