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…
Q：How to deal with the coverage of typical models in medical device registration?
A.————
1.There is no inspection coverage in the review. The so-called coverage refers to the coverage report issued by the inspection institution after checking the product difference and considering that the difference has no impact; more…
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…
