Attachment 1

Chapter I  General Provisions

Article 1  Legislative purpose  In order to ensure the quality and safety of medical devices, protect human health and life safety, and promote the development of the medical device industry, in accordance with the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 739 of the State Council), "Medical Device Registration and Filing Management" Measures" (Order No. 47 of the State Administration for Market Regulation), "Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents" (Order No. 48 of the State Administration for Market Regulation), "Measures for the Supervision and Administration of Medical Device Production" (State Administration for Market Regulation) General Administration Order No. 53), in light of the actual situation of our province, formulate these regulations.

Article 2   Definition The term “extended inspection” as mentioned in these Provisions refers to the comprehensive evaluation of the conformity and effectiveness of the quality management system of the medical device registrant and filer (hereinafter referred to as the "registrant and filer") by the drug regulatory department. Inspection activities carried out by units and individuals that provide products or services in the development and production of medical devices.

Article 3   Scope of application These regulations are applicable to the extended inspection activities in the field of medical devices carried out by drug regulatory authorities at all levels in Guangdong Province.

Article 4   General requirements The personnel who carry out the extended inspection shall be medical device administrative law enforcement personnel, personnel who have obtained the qualification of inspectors according to law, or other personnel who have obtained the authorization of this inspection. The business secrets of the registrant, the filing person, the unit under inspection and the individual shall be kept.

The units and individuals under inspection shall cooperate with the extended inspection, and shall not conceal, refuse, or obstruct, and the relevant documents and materials provided shall be true, complete and accurate.

Article 5   Division of authority The Guangdong Provincial Drug Administration (hereinafter referred to as the "Provincial Bureau") is responsible for the supervision and management of extended inspections. The departments responsible for drug supervision and administration of the local people's governments at or above the county level shall be responsible for the specific implementation of extended inspections.

Article 6  Inspection method Extended inspection can be carried out on-site inspection or online remote inspection.

Chapter II  Start-up

Article 7 Objects of Conduct The drug regulatory department shall carry out extended inspections when necessary for the following conduct objects of registrants and recorders:

 (1) Outsourcing of the R&D process. If the development process of an independent software product is outsourced, the registrant and filing party only conduct verification and confirmation activities;

 (2) Outsourcing of the production process. If the one-time use sterile product is provided by the supplier, the registrant and the filer only carry out the processes such as cleaning, initial packaging and sealing; in vitro diagnostic reagents only carry out the simple sub-packaging process, etc.;

 (3) Outsourcing of warehousing process. Such as entrusting the finished product warehousing process to a third-party service provider;

 (4) Material suppliers. For example, patch manufacturers, material manufacturers or sales companies of active product motherboards;

 (5) Service providers. Such as sterilization services, cold chain transportation service providers;

 (6) Other activities that require extended inspection.

Article 8 Inspection Links Drug regulatory authorities may initiate extended inspections in the following links: 

(1) The verification link of the production quality management system during the first and change registration of medical devices;

 (2) After the first filing of the medical device, change the filing verification link;

 (3) Daily supervision and inspection, unannounced inspection, special inspection, follow-up inspection and other inspection links;

 (4) Complaints and reports, investigation and handling of violations of laws and regulations;

 (5) Investigation and disposal of medical device adverse events;

 (6) Other necessary extended inspection links.

Article 9 Activation Circumstance If the registrant or filing party has any of the following circumstances, the drug regulatory department may carry out extended inspection:

 (1) Complaints and reports or clues from other sources indicate that there may be product quality and safety risks;

 (2) Where the inspection finds that there is a risk of product quality and safety;

 (3) The monitoring of medical device adverse events indicates that there may be product quality and safety risks;

 (4) There is doubt about the authenticity of the relevant information;

 (5) Suspected of serious violation of the requirements of quality management standards;

 (6) Having a record of serious dishonesty;

 (7) Other circumstances that require extended inspection.

Article 10 Graded Approval The extended inspection of Class II and Class III medical device manufacturers shall be carried out after filing with the provincial bureau; the extended inspection of Class I medical device manufacturers shall be conducted to the districted city level. It shall be implemented after filing with the department in charge of drug supervision and administration of the people's government.

Article 11 Situation of Different Place If the object of extended inspection is in another city in the province, if necessary, the provincial bureau will coordinate with the market supervision department of the city where the object of extended inspection is located, and may jointly carry out extended inspection.

If the subject of the extended inspection is in another province and has the qualifications for medical device production and operation, if necessary, the provincial drug supervision and administration department of the place where the subject of the extended inspection is located shall be notified in advance by letter or telephone, and the extended inspection can be jointly carried out.

Article 12 Development of Plan An inspection plan shall be formulated to carry out an extended inspection, specifying the inspection content, time, personnel composition, inspection method and inspection focus, etc.

 When necessary, the drug supervision and administration department may jointly carry out extended inspections with the public security organs and other relevant departments.

Article 13 Requirements for Inspection Team The inspection team for extended inspection shall be composed of two or more qualified personnel, and the inspection team implements the team leader responsibility system. According to the needs of the inspection work, the drug supervision and administration department may invite experts in relevant fields to participate in the inspection work. Personnel participating in the inspection shall sign a declaration of no conflict of interest and a letter of commitment to clean government; if there may be a contradiction or conflict between the inspection activities they are engaged in and their personal interests, they should take the initiative to withdraw.

Article 14 Pre-inspection communication Due to the needs of inspection work, the registrant and filing person shall be responsible for the advance communication and coordination with the inspected units and individuals.

Chapter III Inspection

Article 15 Inspectation Basis The extended inspection shall be carried out according to the content of the quality agreement between the registrant, the recordholder and the unit or individual providing the product or service, in combination with the requirements of the Production Quality Management Specification for Medical Devices and related documents.

Article 16 First Meeting When the on-site inspection begins, the first meeting shall be held. The first meeting shall be attended by members of the inspection team, representatives of the registrant, the record holder and relevant personnel of the unit under inspection. The contents include confirming the scope of the inspection, implementing the inspection schedule, announcing the inspection discipline and precautions, and identifying the company liaison personnel.

Article 17 Recoding Requirement The inspection team shall record the inspection time, place and site conditions in detail; The discovered problems shall be recorded in writing, and when necessary, relevant documents and materials shall be collected or photocopied, and relevant facilities, equipment and materials shall be photographed as well as on-site conditions, collected as well as relevant personnel shall be questioned. The interrogation record shall include the name, position and content of the interview of the subject, and shall be signed page by page or fingerprinted by the subject.

The records shall be timely, accurate, complete and objectively reflect the on-site inspection situation.

Article 18 Key Point of Inspection According to the quality agreement between the registrant, the filer and the units and individuals providing products or services, the extended inspection site focuses on the inspection of the content of the products and services provided, and focuses on the design and development process, The production environment, technological process, production process, quality management, storage and transportation conditions, and the management process connected with the registrant and filer, such as document management, procurement management, etc., shall be checked for factors that may affect the quality and safety of the final product of the registrant and filer.

Article 19 International Discussion During the on-site inspection, the inspection team shall hold an internal meeting to exchange inspection information, study difficult problems and put forward solutions, and obtain evidence when necessary. During the internal meeting of the inspection group, relevant personnel of the enterprise shall withdraw. If necessary, the results of the internal discussion can be reported back to the inspected unit at the last meeting.

Article 20 Collection of Evidence If it is necessary to extract finished products or other materials for inspection during the on-site inspection process, or to take administrative compulsory measures to retain relevant evidence, it shall be carried out in accordance with the relevant requirements of the "Measures for Unannounced Inspection of Drugs and Medical Devices".

The records formed duringthe extended inspection and the relevant materials and objects collected in accordance with the law can be used as the basis for the determination of facts in the administrative punishment.

Article 21 End Requirements The time of on-site inspection shall be determined by the inspection team according to the inspection needs and on the principle of being able to find out the facts. The inspection shall be completed with the approval of the drug regulatory department that organizes the follow-up inspection.

Article 22 Final Meeting When the extended on-site inspection is over, a final meeting shall be held. It is attended by members of the inspection team, registrants, filers and relevant personnel of the inspected unit. The content includes that the inspection team informs the registrant, the filer and the relevant personnel of the inspected unit of the on-site inspection situation, and the registrant, the filer and the relevant personnel of the inspected unit confirm the on-site inspection situation. If the registrant, filing person and the unit under inspection have any objection, they may state and defend, and the inspection team shall record the facts truthfully. If the inspection team refuses to confirm the inspection result, the inspection team shall indicate the reasons.

Article 23 Inspection Report After the inspection, the inspection team shall write an inspection report. The inspection report includes the inspection process, problem discovery, relevant evidence, inspection conclusion, and handling suggestions. The problems found on the site of the extended inspection shall be attributed to the registrant and the filing person.

Article 24 Submission of Report The inspection team shall, within 5 working days after the inspection, submit the inspection report, inspection record and relevant evidentiary materials to the drug regulatory department that organizes the extended inspection.

Chapter IV Handling

Article 25 Measures to be taken According to the results of the extended inspection, the drug supervision and administration department may take rectification within a time limit, issue a warning letter, interview, supervise the recall of products, and suspend the development, production, sales, and use of the registrant and filer according to law. , procurement and other risk control measures. After the risk factors are eliminated, relevant risk control measures shall be lifted in a timely manner.

Article 26 Investigation and Punishment of Violations According to the results of the extended inspection, if an illegal act is found to be filed for investigation and punishment, it shall directly organize the investigation and punishment according to its functions or transfer it to the corresponding department for investigation and punishment;

Article 27 Circumstances of evading inspection If the unit or individual under inspection has any of the following circumstances, it shall be deemed that the registrant or filing person refuses or evades inspection:

(1) Delaying, restricting or refusing inspectors to enter the site or area being inspected, or restricting the inspection time; 

(2) Failure to provide or delay in providing inspection-related documents, records, bills, vouchers, electronic data and other materials without justifiable reasons; 

(3) Deceiving, misleading, or evading inspections by claiming that staff members are absent, intentionally stopping production and operation, etc.; 

(4) Refusing or restricting photographic, photocopying, sampling and other forensic work; 

(5) Other circumstances that do not cooperate with the inspection. 

The inspection team shall make a written record of the behavior of the inspected unit’s refusal or evasion of inspection, and order it to make corrections and report it to the drug supervision and administration department that organized and implemented the extended inspection in a timely manner; For non-compliance with relevant quality management regulations or other relevant requirements. 

Article 28 Implementation time These regulations will come into force on xx, xx, 2022.

Attachment 2

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