Notice on Issuing the 2023 National Medical Device Sampling and Inspection Product Inspection Plan by the Comprehensive Department of the National Drug Administration (Drug Administration General Administration [2023] No. 28)
Release Time:
2023-03-31
To the Drug Administration of various provinces, autonomous regions, municipalities directly under the central government, and Xinjiang Production and Construction Corps, as well as the China Food and Drug Control Research Institute and relevant inspection institutions:
According to the "Notice of the Comprehensive Department of the National Medical Device Quality Inspection and Inspection Bureau on Carrying out the 2023 National Medical Device Quality Inspection and Inspection Work" (Drug Administration Comprehensive Instrument Management [2023] No. 5), the 2023 National Medical Device Inspection and Inspection Product Inspection Plan is now issued to you for your organization and implementation. The relevant requirements are hereby notified as follows:
1、 Inspection work requirements
Each province, autonomous region, municipality directly under the central government, and the Xinjiang Production and Construction Corps Drug Administration, as well as the China Food and Drug Control Research Institute, shall organize relevant inspection institutions to carry out inspection work in accordance with the 2023 National Medical Device Sampling and Variety Inspection Plan (see Annex 1) in accordance with the mandatory standards for medical devices and the registered or registered product technical requirements
2、 Requirements for re inspection work
The re inspection acceptance department for national supervision and sampling in 2023 is the provincial drug supervision and management department where the registrant of medical devices or the agent of imported products is located. The re inspection application for the same inspection report is only processed once. The provincial-level drug supervision and management department that accepts the application for re inspection shall determine the re inspection institution for re inspection based on the list of national medical device sampling and re inspection institutions in 2023 (see Annex 2), and the re inspection institution shall not refuse. For those explicitly designated as risk monitoring sampling in the inspection plan, no re inspection will be conducted
The inspection institutions included in the list of re inspection institutions shall continue to maintain their inspection capabilities and qualifications for corresponding varieties and projects, and have the obligation to undertake the re inspection work in provincial sampling and local drug supervision and management department law enforcement. The re inspection agency shall proactively disclose the contact information for the re inspection to provide convenience for the re inspection work. The requirements for the national medical device sampling and retesting work in 2023 are detailed in Annex 3
If the parties have objections to the inspection conclusion and cannot pass the re inspection verification, they can submit a written application for objection appeal to the provincial drug supervision and management department where they are located. The specific time limit and process shall be handled in accordance with the relevant objection appeal provisions in the "National Medical Device Quality Spot Check and Inspection Work Procedure" (Drug Administration General Administration [2021] No. 46)
3、 Other requirements
After receiving reports of non-compliance with regulations, the medical device registrant and the sampled unit shall immediately take risk control measures. The drug regulatory department shall promptly organize investigations and disposals, and those that meet the conditions for filing shall be promptly filed for investigation and punishment; Those suspected of committing crimes shall be transferred to judicial organs in accordance with the law
Attachment: 1. 2023 National Medical Device Sampling and Variety Inspection Plan
List of National Medical Device Sampling and Re-inspection Institutions in 2023
3. Requirements for National Medical Device Sampling and Re-inspection Work in 2023
General Department of the State Food and Drug Administration
March 28, 2023Previous:
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