During the whole process of medical device lifecycle, the standards will be updated periodically. For example, GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2012, MOD) was published in April, 2020, but will take effect since May 1, 2023. more…
Recently, NMPA have adjusted the classification catalogue of medical devices, adjusted the product description and expected use of 09-07-02 radio frequency (non ablation) treatment equipment, and officially included the radio frequency skin treatment instrument in the classification catalogue of medical devices. In the future, enterprises should obtain the registration certificate of medical devices before producing, importing and selling RF Beauty Instruments. more…
Measures for the Supervision and Administration of Medical Device Production (Order No. 53 of CMSA) (hereinafter referred to as the Production Measures), Measures for the Supervision and Administration of Medical Device Operations (Order No. 54 of the CMSA) (hereinafter referred to as the Operation Measures) have been released and will come into force on May 1, 2022. On March 23, 2022, NMPA issued the Notice of the NMPA on the Implementation of the “Measures for the Supervision and Administration of Medical Device Production and Measures for the Supervision and Administration of Medical Device Operation“, including the following four aspects: more…
On March 24, NMPA issues an announcement on adjusting some of the contents of the Medical Device Classification Catalog, adjusting the contents of the Medical Device Classification Catalog for 10 medical device products including clip devices on 02-15-14. more…
In recent years, with the national policy and the continuous adjustment and optimization of the industrial structure around the country, the medical device industry, as high technology, high growth, high value-added industry, more…
In order to strengthen the supervision of medical device production and ensure the safety and effectiveness of medical devices, according to the relevant provisions of the regulations on the supervision and administration of more…
Recently, the State Administration of Market Supervision issued the revised Measures for the Supervision and Administration of Medical Device Production and the Measures for the Supervision and Administration of Medical Device Operation, which will come into force on May 1, 2022. more…
I．In 2021, the National Medical Device Adverse Event Monitoring Information System received more than 650000 medical device adverse event reports, and the average number of reports per million population was 461. The county-level coverage of adverse event reports of medical devices in 28 provinces (autonomous regions and municipalities directly under the central government) reached 100%. The number of grassroots registered users of medical device adverse event monitoring information system continue to increase, reaching more than 370000, including 29436 medical device registrants. more…
