The current mandatory national standard for medical protective masks is GB 19083-2010, and the industry standard for surgical masks is YY 0469-2011 (latest versions GB 19083-2023 and YY 0469-2023); both set core technical requirements such as filtration performance and fit.
Read MoreIn December 2023, the NMPA issued Announcement No. 153. The revised Good Supply Practice for Medical Device Distribution (Medical Device GSP) took effect on July 1, 2024, covering whole-process distribution quality management across 10 chapters and 116 articles.
Read MoreThe Measures for the Monitoring and Re-evaluation of Medical Device Adverse Events (Order No. 1), jointly issued by the SAMR and National Health Commission, took effect on January 1, 2019, establishing a tiered reporting and re-evaluation system for post-market adverse events.
Read MoreThe Regulations on the Supervision and Administration of Medical Devices (Order No. 739), revised by the State Council in 2021, took effect on June 1, 2021, establishing a classified, tiered full-life-cycle framework as the foundation of current medical device oversight.
Read MoreThe 26,000+ m² Phase II workshop at our Henan Linzhou manufacturing base is now in production, adding multiple fully-automated lines and further strengthening supply security.
Read More