According to the data of CCCMHPIE, in 2021, the import and export trade volume of China’s medical devices reached US $144.087 billion, a year-on-year decrease of 16.87%, of which the export volume was US $99.409 billion, a year-on-year decrease of 24.73%. The decrease in export value is mainly due to the fact that many countries and regions have gradually normalized their response to the epidemic situation, and there are relatively sufficient epidemic prevention materials. In addition, several countries and regions with serious epidemic situation have adjusted their local epidemic prevention policies, and panic procurement has decreased. more…
Recently, Chongqing Medical Security Bureau of China issues the Notice on the Implementation of the Results of Centralized Procurement of Orthopedic Trauma, Coronary Drug Coated Balloon, Pacemaker and Intraocular Lens (hereinafter referred to as the notice). more…
01
Medical Device Registrant System
China first piloted the medical device registrant system in Shanghai Free Trade Zone in 2017. The pilot scope of the system has been expanded to 21 provinces (regions and cities) such as Shanghai, Guangdong, Tianjin, Beijing and Hunan in 2019. more…
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…