The State Food and Drug Administration revised and issued the "Administrative Measures for Quality Sampling Inspection of Medical Devices"

In order to strengthen the post-marketing supervision and management of medical devices, and to further improve the sampling inspection of medical devices, the State Food and Drug Administration organized an amendment to the original "Regulations on the Administration of Quality Supervision and Random Inspection of Medical Devices" (Food and Drug Administration and Apparatus Supervision ﹝2013﹞212). On March 10, 2020, the "Administrative Measures for the Quality Sampling Inspection of Medical Devices" was released.

The "Measures" has 7 chapters and 47 articles, including general rules, planning schemes, inspection sampling, inspection management and report delivery, re-inspection disposal, supervision and management and supplementary provisions. The general idea of the revision is to clarify the responsibilities and requirements of the sampling inspection work of drug regulatory departments at all levels in combination with institutional reforms; emphasize problem orientation and promote the solution of practical problems that plague sampling inspections; strengthen risk control to ensure the investigation, handling, and supervision of unqualified products Enterprise rectification is in place.

In order to further shorten the sampling inspection cycle and improve work efficiency, the "Measures" canceled the sample confirmation link before inspection. For samples drawn during the operation and use links, it is required to indicate that the manufacturer and the agent of imported products think that it is not after receiving the inspection report. The company’s products should be submitted to the provincial drug regulatory authority where it is located, and it will be investigated and verified and disposed of in accordance with the law.

In order to strengthen risk management and control, the "Measures" emphasizes the responsibilities of manufacturers, sampled units, drug regulatory authorities, and inspection agencies. The manufacturer and the sampled unit shall promptly recall, analyze the cause, and adopt risk control measures after being notified that the random inspection product does not meet the requirements; the inspection agency shall immediately notify the drug regulatory department to investigate and handle the case when it finds a serious quality ** risk during the inspection process. , And publish the results of the investigation as required.

The "Measures" also detailed the formulation of the sampling plan, the inspection time limit, the return of samples, the re-inspection process, the disclosure of the sampling results, and the utilization of the sampling data.

Sampling inspection is an important means of post-marketing supervision of medical devices in my country. Drug regulatory authorities at all levels should closely integrate it with supervision and inspection, monitoring and evaluation, and inspection and law enforcement to effectively improve the effectiveness of supervision.

Source: State Drug Administration