Recently, the Shaanxi Provincial Public Resources Trading Center issued a public notice on revoking the qualification of unfilled national unified medical insurance information coding products. more…
On April 20, the NMPA issued a notice on the results of the national supervision and sampling inspection of medical devices. The NMPA organized the product quality supervision and sampling inspection of five varieties, such as intervertebral fusion cage and semiconductor laser treatment machine. A total of 12 batches (sets) of products did not meet the standards. The details are as follows: more…
On March 22, 2022, NMPA published the updated version of China GMP (Good Manufacturing Practice) and GSP (Good Supply Practice). The new GMP and GSP will take effective since May 1st, 2022. BradyKnows QA team made assessment and summarized key updates in new version of China GMP compared with old version as below: more…
For the medical devices approved for registration or filing for the first time, the regular risk assessment report of the product of the previous year shall be completed within 60 days after each full year. The regular risk assessment report of class I medical devices shall be kept by the filer for future reference.For the medical devices that have obtained the renewal registration, the registrant shall complete the regular risk assessment report of this registration cycle at the next application for renewal registration,and keep it for future reference. If the product is not produced and sold during the monitoring period, or the product has been cancelled but is still in circulation, it is also necessary to write a regular risk report. more…
On April 8, the Beijing Municipal Food and Drug Administration issues a public announcement on Soliciting Opinions on the Beijing Administrative Punishment Discretion Benchmark for Medical Devices (Exposure Draft) (hereinafter referred to as the Benchmark), announcing detailed punishment discretion for illegal acts in the development, production, operation and use of medical devices. more…
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…
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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…
