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< \ nI. Requirements for Inspection Work
Inspection institutions should strengthen the collection of situations where all applicable items have not been inspected in accordance with the inspection plan. Where the registrant, filer or agent of imported products fails to provide all the necessary materials and supporting essential items for completing the inspection, or where the technical requirements of the products are incomplete, making it impossible to complete the inspection, a national medical device sampling inspection missing item inspection prompt letter shall be issued to the provincial drug regulatory department where the registrant, filer or agent of imported products is located. This prompt will be transmitted through the National Medical Device Sampling Inspection Information System, and the provincial drug regulatory authorities shall promptly investigate and handle the relevant situations. For those who fail to cooperate with the random inspection and testing of medical device quality without justifiable reasons, the investigation results should be recorded in the enterprise's credit file, and supervision and management of the enterprise and related products should be strengthened through other forms, increasing the intensity and frequency of supervision and inspection. For products with incomplete technical requirements, the enterprise should be supervised to improve the technical requirements as soon as possible and complete the changes in accordance with the law and regulations. The results of the relevant investigation and handling shall be entered into the National Medical Device Sampling Inspection Information System within 30 working days after the issuance of the prompt letter.
II. Requirements for Rechecking Work
The re-inspection acceptance department for the national supervision and sampling inspection in 2024 is the provincial drug regulatory department where the medical device registrant, filer or agent of imported products is located. A re-inspection application for the same inspection report will only be processed once. The provincial drug regulatory department that accepts the application for re-inspection shall determine the re-inspection institution to conduct the re-inspection based on the list of national medical device sampling inspection re-inspection institutions in 2024 (see Annex 2), and the re-inspection institution shall not refuse. For those items clearly designated as risk monitoring spot checks in the inspection plan, no re-inspection will be conducted. The inspection institutions included in the list of re-inspection institutions shall continuously maintain their inspection capabilities and qualifications for the corresponding varieties and items. It is obligated to undertake the re-inspection work in the provincial random inspection and the law enforcement work of local drug regulatory authorities. The re-examination institutions should proactively disclose the contact information for re-examination to facilitate the re-examination work. The requirements for the 2024 national medical device random inspection and re-inspection work are detailed in Attachment 3. If a party has objections to the test conclusion and cannot pass the re-examination verification, they may submit a written application for objection appeal to the provincial drug regulatory department where they are located. The specific time limit and procedures shall be handled in accordance with the relevant provisions on objections and appeals in the "National Medical Device Quality Random Inspection and Testing Work Procedure" (Yaojian Zongmei Guan [2021] No. 46).III. Requirements for Handling Test Results
After the medical device registrant, filer and sampled entity receive the report that the product does not comply with the regulations, they shall immediately take risk control measures. The drug regulatory department shall promptly organize investigations and handling. If the conditions for filing a case are met, a case shall be filed and dealt with in a timely manner. Those suspected of committing crimes shall be transferred to judicial authorities in accordance with the law.