The Shanghai Municipal Food and Drug Administration has issued a notice on the storage of medical devices、Notice of special inspection carried out by distribution service enterprises Certification and Evaluation Center of the Municipal Food and Drug Administration、Law Enforcement Corps of the Municipal Food and Drug Administration、Market Supervision Bureaus of all districts： In order to further strengthen the city's provision of storage for other medical device production and operation enterprises、Supervision of distribution service enterprises (hereinafter referred to as "third-party logistics enterprises").，Implement the main responsibility of enterprises，Supervise and urge the city's medical device tripartite logistics enterprises to carry out medical device storage in accordance with the requirements of the "Implementation Rules for the Quality Management Standards of Medical Device Operation in Shanghai".、Delivery services，In accordance with the "2018 Shanghai Medical Device Supervision Work Plan".，Combined with the actual supervision of the city，The special inspection plan is hereby formulated as follows： One、Inspection object: Obtain the "Medical Device Business License" before the end of 2017，And the business scope of the license includes "providing storage for other medical device production and operation enterprises."、distribution services".，31 in total，So far, 2 have failed to renew their permits on time，Expiration of the original license (Annex 1)。 Two、Inspection content According to the "Medical Device Business Quality Management Standards" and "Medical Device Cold Chain (Transportation、Storage) management guide" and "Shanghai Medical Device Operation Quality Management Standards Implementation Rules" in the relevant requirements，Focus on whether the actual storage and transportation situation of the tripartite logistics enterprise is consistent with the permitted items，Whether it is in accordance with the medical device product label、Labeling requires the product to be stored、transport，Whether the real-time regulatory information platform provided to the regulatory authorities is true and consistent with reality，Enterprises carry out self-inspection and verification of the implementation of GSP such as the implementation of rectification and rectification，For details of the specific inspection of this special project, please refer to the "2018 Special Inspection Form" (Annex 2)。 The criterion for judging the inspection conclusion is that all the inspection items meet the requirements as "passing the inspection"，If more than one inspection item (including one) does not meet the requirements, it is "rectification within a time limit"，The on-site inspection is suspected of violating laws and regulations and requires further investigation，After fixing the evidence at the scene，Promptly file a case for handling。 Three、Inspection arrangements (1) Inspection time: August 1, 2018 - October 31, 2018 (2) Division of work The Drug and Medical Device Circulation Supervision Department of the Municipal Food and Drug Administration is responsible for formulating the overall plan，Determine the list of companies to be inspected，Be clear about inspection requirements，Develop an on-site checklist，Disclosure of information on the results of supervision and inspection, and coordination of related work during the inspection。 The Certification and Evaluation Center of the Municipal Food and Drug Administration is responsible for organizing the inspection，Combined with daily permit check arrangements，Make an inspection plan，According to the number of corporate warehouses、The size of the enterprise is reasonably arranged for the inspection time，Summarize the inspection results and special summaries。 The law enforcement team of the Municipal Food and Drug Administration sent personnel to participate in the inspection，Serve as the inspection team leader according to the inspection arrangement。Conduct audits around the legitimacy of the enterprise，Detection of violations，Promptly file a case for handling。 The District Market Supervision Bureau sends personnel to participate in the inspection of enterprises within its jurisdiction。 (3) Composition of inspectors The inspection team is certified and evaluated by the Municipal Food and Drug Administration、Law Enforcement Corps of the Municipal Food and Drug Administration、The market supervision bureau of the district where the enterprise is located shall be composed of 1 person each，The Pharmaceutical and Medical Device Circulation Supervision Department of the Municipal Food and Drug Administration sent personnel to participate in the work arrangement。 The Certification and Evaluation Center of the Municipal Food and Drug Administration shall arrange according to the inspection，Notify the law enforcement team of the municipal bureau and the market supervision bureau where the enterprise is located one week in advance，And the inspection arrangements will be copied to the Municipal Bureau of Medicine and Equipment Circulation。 Four、Inspection requirements (1) Implement the team leader responsibility system。The team leader should do a good job of checking the division of labor and task arrangement，Conscientiously check one by one in accordance with the content of this special inspection，Record and photograph the non-conformities found at the scene，Make copies of relevant documents，Record the inspection site situation、issues found, etc，And it is signed and confirmed by the inspected enterprise。The inspection results are entered into the post-certificate supervision system of our bureau in a timely manner，The inspection form shall be sent to the Drug and Medical Device Circulation Department of the Municipal Food and Drug Administration within one week after the end of the inspection。 (2) Timely disposal of inspection results。It is necessary to rectify within a time limit，It should be immediately reported to the Drug and Drug Circulation Supervision Department of the Municipal Food and Drug Administration；Suspected of violating laws and regulations，The case will be investigated by the Law Enforcement Corps，Dispose of it in accordance with the law。 (3) Supervise and urge enterprises to rectify in place。Defects found during the inspection，The Municipal Food and Drug Administration's Drug and Medical Device Circulation Supervision Department issued a "Notice of Rectification within a Time Limit" to the enterprise，The enterprise shall submit a rectification report to the inspection team within 7 days，And complete the rectification within a time limit。 (4) Strictly abide by the discipline of clean government。In the supervision and inspection，The inspection team should administer in strict accordance with the law。Check Chinese law enforcement，Corporate catering banquets and vehicle transfers are not accepted，It is forbidden to take the opportunity of the inspection to accept gifts and gifts from the inspected unit。 Notice is hereby given。 annex： 1.List of third-party logistics enterprises for medical devices in Shanghai (as of the end of 2017) 2. Storage of medical devices in Shanghai in 2018、Special Checklist for Distribution Service Enterprises Shanghai Food and Drug Administration July 24, 2018 (Contact：Chen Wei, Department of Drug and Medical Device Circulation Supervision Tel：23118222Visibility (Scope.)：Voluntary disclosure)
