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The National Medical Products Administration revised and released the "Management Measures for Quality Spot Checks and Inspections of Medical Devices"
Release time:
2025-03-12 09:41
To strengthen the post-market supervision and management of medical devices and further improve the medical device sampling inspection work, the National Medical Products Administration (NMPA) revised the original "Regulations on the Supervision and Inspection of Medical Device Quality" (Food and Drug Administration Medical Device Supervision [2013] No. 212) and issued the "Measures for the Quality Sampling Inspection of Medical Devices" on March 10, 2020.
The Measures consist of 7 chapters and 47 articles, including general principles, plans and schemes, inspection sampling, inspection management and report delivery, re-inspection and disposal, supervision and management, and supplementary provisions. The overall approach to the revision is to clarify the responsibilities and requirements of drug regulatory departments at all levels for sampling inspection work in conjunction with institutional reforms; to emphasize a problem-oriented approach, promoting the resolution of practical problems hindering sampling inspection work; and to strengthen risk control, ensuring the investigation and handling of unqualified products and urging enterprises to rectify problems.
To further shorten the sampling inspection cycle and improve work efficiency, the Measures Cancel the sample confirmation stage before inspection. For samples collected during the sales or use stages, it is stipulated that if the declared manufacturer or importer's agent believes that the samples are not from their company after receiving the inspection report, they should submit their claim to the provincial drug regulatory department where they are located, which will investigate and verify the matter and deal with it according to the law.
To strengthen risk control, the Measures emphasize the responsibilities of manufacturers, sampled units, drug regulatory departments, and testing institutions. After manufacturers and sampled units are informed that the sampled products do not meet the regulations, they should promptly recall the products, analyze the causes, and take risk control measures. If a testing institution discovers serious quality and safety risks during testing, it should immediately notify the drug regulatory department to investigate and handle the matter, initiate an investigation, and publicize the results of the investigation as required.
The Measures also detail the formulation of sampling plans, inspection time limits, sample return, re-inspection procedures, the publication of sampling results, and the use of sampling data.
Sampling inspection is an important means of post-market supervision of medical devices in China. Drug regulatory departments at all levels should closely integrate it with supervision and inspection, monitoring and evaluation, and investigation and law enforcement work to effectively improve regulatory efficiency.
Spot checks, inspections, testing, pharmaceuticals, regulatory agencies, medical devices, enterprises, risks, measures, work
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