From May 1, the new version of China’s Measures for the Supervision and Administration of Medical Device Production and Measures for the Supervision and Administration of Medical Device Operation begins to be officially implemented. more…
On April 27, the National Development and Reform Commission issued the work Plan for orderly expansion of the Construction of National Regional Medical Centers, which proposes that the nationwide planning and layout should be basically completed by the end of 2022, and that the construction of national regional medical centers should cover all provinces of the country. more…
On March 31, a Decision on Administrative Punishment issued by Guizhou Provincial Drug Administration showed that more than 10.12 million disposable medical surgical masks of Guizhou Junjiang Industrial Co., Ltd. were fined nearly 5.62 million yuan for failing to organize production and sterilization as required. more…
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…
