Q: The specification stipulates that batch number management regulations should be established to clarify the relationship between the production batch number and the sterilization batch number. Does the production batch and the sterilization batch must be consistent? more…
Recently, the CMDE of the NMPA has issued the Guidelines for the Examination of Medical Device Software Registration (revised in 2022). The new version has revised its content and requirements regarding the concept, survival cycle, validation, testing, validation and functional use of the medical device software. more…
The newly revised Regulations on the Supervision and Administration of Medical Devices stipulates that the product inspection report submitted during medical device registration can be the self-inspection report of the medical device registration applicant or filer, or the inspection issued by a qualified medical device inspection agency. Report. This is the first time that China has allowed medical device registration applicants or filers to submit self-inspection reports for medical device product registration at the level of national regulations. more…
China‘s dongshiju.com and http://datatechnology.com.cn/ jointly released the Seventh China’s Top 100 Most Influential Pharmaceutical Enterprises in 2021 。The list is mainly assessed from the marketing management indicators, financial indicators and innovation indicators, and then weighted and summarized by the experts of the jury. Finally, the top 100 pharmaceutical enterprises such as Mindray medical, Sinopharm, Wantai Biopharma and Yunnan Baiyao are determined. more…
On February 22, NMPA issues a notice on printing and distributing the 2022 national inspection plan for sampling products of medical devices, involving uric acid determination kit ,β 2-microglobulin detection kit (immunoturbidimetry), myoglobin detection kit (immunoturbidimetry), human papillomavirus (HPV) nucleic acid detection reagent and other IVD products. more…
According to JOINCHAIN statistics, from 2017 to 2021, a total of 7749 II and III medical device manufacturers were added, with an average annual growth of 1550. The new value-added was the highest in 2020, 2960, and the lowest in 2019. more…
