NMPA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
NMPA Publishes 46 Medical Device Industry Standards (14 August 2026)
2026-08-14 | NMPA | Standard Revision | !!! HIGH
On 14 August 2026 NMPA published 46 medical device industry standards covering biomaterials, life support, implants, biological evaluation and software measurement methods. Two mandatory standards (YY 0055-2026 dentistry powered polymerization activators; YY 1412-2026 extracorporeal cardiopulmonary support) take effect on 1 August 2029. Two recommended standards take effect on 1 February 2028; the remaining 42 recommended standards take effect on 1 August 2027.
Tags: standards, YY, industry_standard, nmpa
NMPA Announcement No. 56 (2026) -- Withdrawal of 10 Medical Device Industry Standards
2026-06-04 | NMPA | Standard Revision | !!! HIGH
Published 4 June 2026. NMPA withdraws 10 YY/T industry standards (transcatheter heart valves, anaesthetic/respiratory connectors and medical gas systems) and replaces them with corresponding GB/T national standards. Six standards are withdrawn on the announcement date; YY/T 0882-2013 on 1 July 2026; YY/T 0799-2010, YY/T 0801.1-2010 and YY/T 1439.2-2016 on 1 August 2026.
Tags: standards, abolished, YY, GB, nmpa
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