Medical Devices

In December 2024, China’s NMPA issued a notice regarding adjustments to the classification codes for in Vitro diagnostic reagents.|In December 2024, China’s NMPA issued a notice regarding adjustments to the classification codes for in Vitro diagnostic reagents.

NMPA’s 2025 IVD Catalogue is now in effect with key changes for overseas registration. Contact Cisema for expert support.

NMPA issues draft changes to China’s IVD Classification Catalogue, adding new risk classes and technology platforms.

China medical device master filing aims to protect confidential information from being disclosed during the NMPA registration process

Medical Device Master Files in China were introduced in 2021 but the NMPA has clarified their use for the registration of medical devices

The NMPA announced the implementation of a mNMPA Introduces the Medical Device Master Filing System covering both medical devices and IVDs.

Learn how China’s medical device master file system supports confidential documentation, protects IP, and streamlines regulatory reviews for international manufacturers.

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

Vietnam’s Ministry of Health has delegated medical device oversight to specialized agencies, impacting registration and post-market surveillance.

Vietnam's Decree No. 26/2026/ND-CP” confirms MoH oversight of chemicals in medical devices, IVDs, and medicines.

Vietnam’s Ministry of Health moves to standardize and digitize medical device administration, improving transparency and compliance.

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