The country issued new regulations on medical device inspections
On September 26, the National Medical Products Administration issued the “Notice on Issuing the Guidelines for On – site Inspection of the Quality Management Specifications for Online Sales of Medical Devices” (referred to as the “Guidelines”).
These Guidelines apply to the supervision and inspection conducted by the departments responsible for drug supervision and administration in accordance with the law on medical device online sellers and medical device e-commerce platform operators. In view of the fact that medical device online sellers and medical device e-commerce platform operators may differ in terms of their business service methods, business scopes, etc., during the inspection process, operators can, according to the characteristics of their business service methods, business scopes, etc., identify reasonable missing items by referring to the guidelines, and provide a written explanation of the reasons, which shall be confirmed by the inspection team dispatched by the drug regulatory department.
During supervision and inspection, if all applicable items for medical device online sellers and medical device e-commerce platform operators meet the requirements or can be rectified on the spot, the inspection result is “Passed the inspection”; if only general items (unmarked items) do not meet the requirements, or the number of non-compliant items among key items (marked with ※) is less than 3, and the total number of non-compliant items among key items and general items is less than 6, the inspection result is “Rectification within a time limit”; if the number of non-compliant items among key items is 3 or more, or there are non-compliant key items and the total number of non-compliant items among key items and general items is 6 or more, the inspection result is “Failed the inspection”.
After receiving the rectification report, the department in charge of drug supervision and administration may organize a re-inspection of the enterprise according to the actual situation. If it confirms that the rectification meets the requirements, it shall determine that the “inspection is passed”; if the rectification report is not submitted within the specified time limit or the re-inspection finds that the rectification items still do not meet the regulations, it shall determine that the “inspection is not passed”.
For those that “fail the inspection”, the drug regulatory department may make the inspection results public, and conduct a responsibility interview with the legal representative or the main person in charge of the medical device online sellers and medical device e-commerce platform operators in accordance with the law. If hidden dangers in the quality and safety of medical devices are found during the inspection, they shall be disposed of in accordance with relevant regulations. If during the inspection, it is found that medical device online sellers or medical device e-commerce platform operators have violated laws, regulations and rules such as the E-Commerce Law of the People’s Republic of China, the Regulations on the Supervision and Administration of Medical Devices, and the Measures for the Supervision and Administration of Medical Device Operation, the drug regulatory department shall investigate and deal with them in accordance with the law.
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By NMPA：
Translated & edited：Bradyknown
