NMPA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
NMPA Announcement No. 52 (2026) -- Medical Device Classification Adjustment Procedures
2026-06-01 | NMPA | Regulation Update | !!! HIGH
Published 1 June 2026, this announcement clarifies transitional procedures when medical device management categories or attributes are adjusted. Covers: registration/filing requirements when classification changes from higher to lower class; transition from medical device to non-medical device status; timeline and documentation requirements for affected manufacturers.
Tags: classification, registration, transition, compliance
NMPA Announcement No. 21 (2026) -- UDI Full Coverage Implementation Timeline
2026-03-13 | NMPA | Regulation Update | !!! HIGH
Published 13 March 2026, jointly issued by NMPA, National Health Commission and National Healthcare Security Administration. Mandates UDI implementation for all remaining medical device categories: all Class II devices and Class I IVDs by 1 June 2027; all Class I devices by 1 June 2029. Manufacturers must complete UDI assignment, data upload and maintenance. Provincial drug regulatory authorities are to coordinate with health and healthcare security departments to promote integration.
Tags: udi, traceability, full_coverage, multi_department
NMPA Announcement No. 15 (2026) -- UDI Exemption for Specific Circumstances
2026-03-13 | NMPA | Regulation Update | !! MEDIUM
Published 13 March 2026, defines 7 circumstances where medical devices are exempt from UDI implementation: clinical trial devices, custom-made devices, device components, post-market study devices, and others. For reusable devices where direct marking may affect safety, UDI must be marked on the smallest sales unit packaging with alternative traceability solutions.
Tags: udi, exemption, clinical_trial, custom_device