Guangdong Pharmaceutical Regulatory Office [2022] No. 133

Relevant departments:

In order to do a good job in the verification of medical device registration quality management system, according to the "Regulations on The Supervision and Administration of Medical Devices", "Administrative Measures for Registration and Filing of Medical Devices", "Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents" and "Procedures for verification of The Quality Management System for Registration of Category III Medical Devices in China". In light of the actual conditions of Guangdong Province, Guangdong Provincial Drug Administration (hereinafter referred to as the Provincial Bureau) has organized and revised the Working Procedures for The Verification of The Quality Management System for Registration of Class II Medical Devices in Guangdong Province, which is hereby promulgated and shall come into force as of today. The job requirements are as follows:

1. The provincial Bureau of examination and Certification Center (with the brand of Drug Inspection Center) (hereinafter referred it as the Examination Center) shall be specifically responsible for and undertake the verification of the quality management system of the registration of category II medical devices, and the technical review, on-site inspection and data audit of the verification of the quality management system of the registration of category III medical devices. After receiving the verification materials of category III medical device system transferred by provincial bureau, the evaluation center shall complete the verification within 25 working days and put forward the verification conclusion. If it is necessary to review after rectification, the review shall be completed within 25 working days after the registration applicant submits the rectification report. After receiving the verification conclusion of the evaluation center, the provincial bureau shall issue the system verification result and submit it to the Medical device Technical Evaluation Center of the National Medical Products Administration.

2. In case of special circumstances such as epidemic prevention and control, the evaluation center may adopt flexible methods such as online or offline combination to carry out systematic verification.

Appendix: Verification procedures of the Quality management System for registration of Class II medical devices in Guangdong Province

Office of Guangdong Provincial Drug Administration

2022.4.27

Appendix: 

Procedures for the verification of quality management system for registration of category II medical devices in Guangdong Province

Article 1 in order to do a good job in the second category of medical device registration quality management system verification, according to the regulations on the supervision and administration of medical devices "medical device registration and filing management method" the measures for the administration of the registration and archival filing in vitro diagnostic reagent of the quality management system in class iii medical device registration verification procedures ", combining the reality of Guangdong province, formulated procedures.

Article 2  This procedure is applicable to the verification of class II medical device registration quality management system within the jurisdiction of Guangdong Province.

Article 3 The Drug Administration of Guangdong Province (hereinafter referred to as the provincial bureau) shall be in charge of the verification of the quality management system for the registration of class II medical devices in the province and carry out effectiveness evaluation. Provincial bureau of evaluation and certification center (plus hanging inspection center brand) (hereinafter referred to as the evaluation center) is specifically responsible for and undertake the second type of medical device registration quality management system verification process of technical review, on-site inspection, data audit, conclusion review and results informed work.

Article 4 For system verification involving interprovincial entrusted production, the evaluation center may request the provincial bureau to negotiate with the provincial drug regulatory department where the entrusted manufacturer is located to jointly carry out or entrust on-site inspection.

Article 5 The evaluation center shall start system verification within 10 working days from the date of receiving the application materials for registration of medical devices, and complete all verification work within 30 working days after the start. If it is necessary to review after rectification, the review shall be completed within 20 working days after the registration applicant submits the rectification report.

Article 6 The evaluation center shall carry out the quality management system verification related to product development and production in accordance with the requirements of the production quality management standards for medical devices, the relevant appendices and the verification guide for registered quality management system.

In the process of verification, the authenticity of the products for testing and the products for clinical testing used by the registered applicant shall be verified simultaneously. Mainly refer to the relevant records of the implementation planning and control of the design and development process, as well as the purchase records, production records, inspection records and retention sample observation records for product production.

Where the self-inspection report is submitted, emphasis shall be placed on the inspection ability and results of the registered applicant or the entrusted institution in the process of development.

Article 7 The evaluation center shall arrange on-site inspection according to the specific situation of the applicant, the supervision and inspection, and the comparison of the production conditions and technology of the products applied for registration with the products that have been verified in the past, so as to avoid repeated inspection.

If the products have the same working principle, expected use, and basically the same structure composition, production conditions and production process, the authenticity of the products for inspection and clinical trial can only be verified during the on-site inspection, with emphasis on checking the relevant records of the implementation planning and control of the design and development process. Used for purchasing records, production records, inspection records and retention sample observation records of product production.

Article 8 If any of the following circumstances are met, only data examination shall be carried out in principle, and on-site inspection shall be carried out when necessary:

   (1) Application for registration of category II medical devices by annual quality credit class A manufacturing enterprise (hereinafter referred to as Class A enterprise);

   (2) a year in the original production address verification through system (including the third type of system verification), apply for the same production quality management standard appendix (refer appendix, customised denture in the appendix, the same below), or belong to the category level product category and product of the same type system verification (product type refers to the active, passive, sterile, customised denture, independent software, etc., The same below);

   (3) Registration of changes in medical devices (excluding situations that may affect the safety and effectiveness of medical devices, such as the need to carry out on-site verification of self-testing ability and major production process changes);

   (4) Other circumstances in which data review is required.

Article 9 If the self-inspection report submitted by the registration applicant meets one of the following circumstances, only data examination shall be carried out in principle, and on-site verification shall be carried out when necessary:

(1) The scope of self-inspection laboratory has been approved by China National Accreditation Service for Conformity Assessment (CNAS);

(2) Within one year, the products belonging to the same category of grade I products in the classification catalogue and of the same product type have passed the on-site verification of self-inspection ability;
(3) it has passed the self-examination ability verification organized by the provincial bureau;
(4) Entrusting a qualified medical device inspection institution for the inspection of all items in the self-inspection report;
(5) the evaluation center considers that the self-inspection items of the enterprise are relatively simple and have low requirements for inspection instruments and test methods;
(6) Other circumstances requiring only data review.

Article 10 After passing the system inspection (including the third type of system inspection) and applying for the system inspection of the same appendix to the Production quality management Code within two years, the on-site inspection may only carry out the authenticity inspection of products.

Article 11 If the applicant meets the circumstances prescribed in Article 8, 9 and 10, the evaluation center shall verify the explanations and relevant certificates submitted by the registration applicant in the verification materials of the registration application system.

Article 12 On-site inspections shall be carried out under the following circumstances:

(1) the first application for initial registration of a newly established enterprise;

(2) Applications for the first registration of production at A new address (excluding category A enterprises);
(3) Carrying out system verification in accordance with the appendix of production quality management specifications that has not been applied before (excluding Class A enterprises);
(4) Review after rectification of key items that do not meet the requirements;
(5) Other circumstances in which it is considered necessary to carry out on-site inspection in the course of technical evaluation.

Article 13 The evaluation center shall formulate on-site inspection plan before carrying out on-site inspection. The contents of the on-site inspection plan include: basic information of the enterprise, inspection variety, inspection purpose, inspection basis, on-site inspection time, schedule, inspection items, inspection team members and division of labor, etc. The on-site inspection usually takes 1 to 2 days. If the inspection cannot be completed within 2 days, the time can be extended appropriately.

The inspection team shall be composed of at least two inspectors (including two), and the pharmaceutical supervisory and administrative department of the city divided into districts where the enterprise is located may send one observer to participate in the on-site inspection. When necessary, the evaluation center may invite relevant experts to participate in the on-site inspection. For those who submit the self-inspection report, personnel familiar with the inspection shall be selected to participate in the inspection.

Article 14 The system of group leaders responsible for on-site inspections shall be implemented. The inspection team leader is responsible for organizing the first meeting, the last meeting and the internal meeting of the inspection team, summarizing the data of the on-site inspection and reviewing the conclusions of the on-site inspection.

Article 15 The first meeting shall be held when the on-site inspection begins. The first meeting shall be attended by members of the inspection team, observers, representatives of the responsible person and/or management of the enterprise, and relevant personnel. The contents include confirmation of inspection scope, implementation of inspection schedule, announcement of inspection discipline and matters needing attention, and confirmation of contact personnel.

Article 16 Inspectors shall carry out inspections according to the inspection plan and truthfully record the problems discovered during the inspections.

Article 17 During the on-site inspection, the inspection team shall hold an internal meeting to communicate the inspection situation, study difficult problems and put forward handling suggestions, and obtain evidence when necessary. Before the inspection is completed, the inspection team shall hold an internal meeting to make summary and assessment and keep truthful records. Personnel of the enterprise shall withdraw from the internal meeting of the inspection team.

Article 18 The last meeting shall be held at the end of the on-site inspection. The last meeting shall be attended by members of the inspection team, observers, representatives of the responsible person and/or management of the enterprise, and relevant personnel. The contents include the inspection team informing the enterprise of the on-site inspection, and the enterprise confirming the on-site inspection. If there is any objection to the problems found in the inspection, the enterprise shall provide written explanations, relevant evidence and certification materials on the spot, and the inspection leader shall hand them back to the evaluation center.

Article 19 The inspection team shall issue a recommendation conclusion for the on-site inspection, which shall be divided into three cases: "passing the inspection", "reexamination after rectification" and "failing the inspection".

Article 20 The evaluation center shall, within 5 working days after the completion of the on-site inspection, examine the on-site inspection materials submitted by the inspection team and put forward verification conclusions, which shall be divided into three cases: "passed verification", "rechecked after rectification" and "failed verification". For those who need to be corrected after review, the evaluation center shall inform the registered applicant of the contents that need to be corrected.

Article 21 For post-rectification review, if the evaluation center can verify it through materials and the enterprise does not have defects of key items, on-site review shall not be conducted in principle. The time when the registered applicant completes the rectification and submits the rectification report within 6 months shall not be included in the time limit of the evaluation work.

If the rectification report is not submitted within the prescribed time limit, or the rectification review still fails to meet the requirements of "passing the verification", the verification conclusion shall be "failed to pass the verification after rectification". If the rectification has passed the verification, the verification conclusion shall be "passed the verification after rectification".

Article 22 If the registration applicant fails to accept the on-site inspection due to force majeure, the evaluation center may extend the inspection once within the time limit upon the written application of the registration applicant. Where the registered applicant refuses to accept the on-site inspection of the quality management system without reason, the verification conclusion shall be "failed verification".

Article 23 After the evaluation center makes a conclusion of "passing verification" or "passing verification after rectification" or "failing verification" or "failing verification after rectification", it shall inform the applicant of the result by sending prompt message or providing web page inquiry.

Article 24 If the medical devices of category II fail to pass the verification, the evaluation center shall put forward the evaluation opinion of not registering the medical devices, and the provincial bureau shall make the decision of not registering the medical devices.

Article 25 If the registration applicant needs to change the production address due to special reasons such as planning adjustment or house demolition after the completion of product inspection, the evaluation center may, upon the written application of the registration applicant, carry out product authenticity and corresponding system verification before the change.

Article 26 The inspection of the quality management system shall be carried out in strict compliance with laws and regulations, inspection disciplines, state secrets and the secrets of the inspected units, and the relevant requirements for clean government shall be observed.

Article 27 The provincial bureau shall strengthen the supervision and guidance of the system verification, timely discover the deficiencies existing in the work, further improve the working mechanism, and constantly improve the quality and efficiency of the system verification. Those who dereliction of duty, perfunctory responsibility, shirking responsibility and delay in work, thus causing adverse consequences, shall be investigated for their responsibilities in accordance with the law.

Article 28 This procedure shall go into effect as of the date of promulgation. In case of any inconsistency between the previous provisions and this procedure, this procedure shall prevail. The Notice on Printing and Distributing the Inspection Procedures of The Quality Management System for The Registration of Class II Medical Devices in Guangdong Province (Interim) issued by the former Office of Guangdong Food and Drug Administration (CFDA Ban Fang 'an (2015) No. 552) shall be abolished at the same time.