State Food and Drug Administration | Public solicitation Guidelines for verification of medical device registration quality management system opinion,ZOOP

State Food and Drug Administration | Public solicitation Guidelines for verification of medical device registration quality management system opinion

time： 2022/06/02

To strengthen the supervision and guidance of registration under the medical device registrant system,Further improve the verification quality of medical device registration quality management system,according to 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 Measures for the supervision and administration of medical device production Relevant requirements of laws and regulations,The National Bureau organized and revised Guidelines for verification of medical device registration quality management system See attachment ,We are now seeking public opinions.Please2022year6month27A few days ago,Feedback comments or suggestions by email tomdgmp@cfdi.org.cn,Please specify the subject of the email Feedback on the revised guideline for verification of medical device registration system .

General Department of the State Food and Drug Administration

2022year5month23day

The following are enclosure text

Guidelines for verification of medical device registration quality management system

Revised exposure draft

1.Purpose and basis

To strengthen the verification management of medical device registration quality management system,Ensure the quality of inspection work,according to 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 Measures for the supervision and administration of medical device production Medical device production quality management specification Code for quality management of clinical trials of medical devices Regulations on self inspection management of medical device registration etc.,Develop this guide.

2.Scope of application

This guideline is applicable to the second category of medical device On site verification of registration quality management system for class III medical devices.

3.Basic Requirements

3.1 quality management system The applicant for registration shall Medical device production quality management specification And appendix requirements,Based on scientific knowledge Experience and quality risk management principles,Establish a quality management system suitable for the product realization process,Including entrusted production if there be clinical evaluation Including clinical trials Etc,To ensure its effective operation in the whole life cycle management process of medical devices,Guarantee design and development Production and other process data are true complete Traceability,And consistent with the registration and declaration materials.

3.2 Registration verification requirements It shall organize the verification of the registration quality management system in combination with the registration application materials,Focus on product development Design and development related to production purchase Production management Quality control, etc.The verification of product authenticity shall be comprehensive objective.

3.3 Self inspection and verification requirements To submit self inspection report,Should be in accordance with Regulations on self inspection management of medical device registration ,Combined with the submitted product technical requirements,Confirm the quality control system and capability of the registration applicant item by item.

3.4 Extended inspection requirements Development of existing design Registration applicant who entrusts other enterprises with product production and other activities,The scope of verification shall cover the entrusted R & D or entrusted production enterprises.If necessary,Extended inspection shall be conducted for other units that provide products or services for the development of medical devices.

4.Key verification contents

4.1Quality management system principles

4.1.1 quality management system The applicant shall combine the characteristics of the product,Establishment covers design development production Quality management system suitable for product realization process such as quality control and release audit,And shall include entrusted production if there be clinical evaluation Including clinical trials etc..

4.1.2 risk management The applicant shall establish a quality risk management system,Evaluate the quality risk of product realization process according to scientific knowledge and experience,To ensure product quality.

4.1.3 Self test Applicant's self inspection,The self inspection shall be incorporated into the product quality management system and meet the requirements.

4.2Organization and personnel

4.2.1 Organization The applicant shall establish a relationship with the design and development of medical devices Management organization suitable for production,Define the responsibilities of each department,Ensure that design and development knowledge and technology transformation are reasonable and traceable.

4.2.2 personnel The applicant shall provide an appropriate number of R & D personnel with corresponding qualifications Production and quality control personnel,The personnel shall have the professional knowledge and work skills appropriate to the products applied for registration.

4.2.3 Key personnel Management representative Production leader Quality Director Key personnel such as product release audit shall be familiar with the key quality control of the product Key production operation requirements.

4.2.4 Self inspection personnel Applicant submits self inspection report,The quality inspection department shall be equipped with a sufficient number of full-time inspectors.Educational background of inspectors The technical capability shall match the product inspection work.Inspector Reviewer The approval personnel shall be authorized by the applicant in accordance with the provisions.

4.3workshop Facilities and equipment

4.3.1 Plant facilities The applicant shall be equipped with plants and facilities suitable for the production of the declared registered products.Product design and development shall be carried out in appropriate plants and facilities.Plant and facilities for development and production of inspection and clinical trial products,It shall meet the quality control requirements for R & D and developed products.

4.3.2 Production equipment The applicant shall be equipped with production equipment and technological equipment suitable for the production of the declared registered products.Equipment and equipment for the development of registered inspection and clinical trial products,It shall meet the requirements of product quality and development scale.

4.3.3 Inspection equipment The applicant shall be equipped with instruments, equipment and environmental facilities that meet the requirements of inspection methods.Laboratory for special professional inspection,Its environmental facilities shall meet its specific professional requirements.

4.3.4 Production of registered inspection and clinical trial products The plant facilities and equipment used for registration inspection and clinical trial product development and relevant use records shall be kept.In case of force majeure,Product development Sample production and verification records shall be complete Authenticity and traceability.

4.4file management

4.4.1 System documents The applicant shall establish the quality management system documents corresponding to the products applied for registration,Including quality manual Procedure documents Technical documents and data records, etc.Technical documents shall include product technical requirements and relevant standards Production process specification Operation instruction Inspection and test procedures and other relevant documents.data Records shall ensure product design and development Material purchase production Quality Control Traceability of product release and other activities.

4.4.2 Original R & D records The original data of design and development shall be included in document management.Except for test data directly output,Auxiliary records during design and development shall also be kept,For example, major material collection records Instrument and equipment use record Weighing record Preparation records, etc,Ensure traceability of design and development process.To conduct clinical trials,The test instruments related to the clinical trial process shall be retained reagent Delivery record Storage and transportation records Recycling and disposal records, etc.

4.4.3 Validation data The applicant shall retain the research materials and data verified after product design and development or technology transfer,Including but not limited to relevant reviews of non clinical studies and clinical studies Scheme and report, etc,And shall ensure the authenticity of the data accuracy Complete and traceable.

4.4.4 Clinical trial document management The applicant shall establish a basic document management system for clinical trials,Press medical apparatus and instruments/Contents of basic documents to be kept for clinical trials of in vitro diagnostic reagents It is required to keep relevant clinical trial documents and ensure their authenticity accuracy Complete and traceable.

4.5Design development

4.5.1 Design and development documents The design and development documents of medical devices shall be derived from the design and development planning input output Design conversion activities verification Relevant documents confirmed,Including records established during design and development,The traceability of the final output process of previous design and development and its related activities shall be ensured.

4.5.2 Design and development input Design and development input shall generally include laws and regulations national standard Industry standard Domestic and foreign guide documents Standard or reference material information Application of in vitro diagnostic reagents Technical indicators of previous generation or similar products Product risks, etc,At the same time, the input should include a clear scope of application.

4.5.3 Design and development output The design and development output shall meet the input requirements,And meet the needs of users and product design,Attention should be paid to the scope of application of the product Functionality Security Effectiveness Quality controllability.

4.5.3.1 Passive medical devices The components of raw materials of passive medical devices shall meet the requirements of relevant standards,And complete the biocompatibility study.Reusable sterile products during repeated sterilization,The raw material performance shall be evaluated and the study on tolerable repeated sterilization shall be completed.

4.5.3.2 Active medical devices Active medical devices shall be identified Implement mandatory national standards for medical electrical equipment Industry standards and other requirements,And complete the protection against electric shock hazard Mechanical hazard protection Radiation hazard protection Overtemperature hazard protection electromagnetic compatibility Biocompatibility, etc.

4.5.3.3 Animal origin Allogeneic medical devices Medical devices of animal origin shall complete the species of animals If the risk is related to the strain, the strain shall be defined Geographical origin For species whose geographical origin cannot be determined,Provide identification and traceability requirements during the survival of source animals Age Applicable when related to risk,For example, animals' susceptibility to naturally occurring transmissible spongiform encephalopathy Sampling site and type of tissue Health status of animals and tissues Risk assessment and related research on the applicability of virus inactivation methods.

4.5.3.4 In vitro diagnostic reagent Main raw materials involved in the study of in vitro diagnostic reagents intermediate The source of important auxiliary materials shall be clear and meet the requirements,Equipment used during the study Instruments and reagents shall meet the research requirements,Ensure reliable and traceable data.

4.5.4 Validation The applicant shall determine the confirmation or verification work to be carried out,To prove that the key elements of relevant operations can be effectively controlled.The scope and extent of confirmation or verification shall be determined through risk assessment.

4.5.5 Design transformation verification The applicant shall keep all records of product design conversion activities,To show that the design and development output has been fully verified and suitable for routine production before becoming the final product specification,And ensure that the production process uses the determined raw materials and equipment,Continuously and stably produce products that meet the expected use and product technical requirements.as Validation and validation of sterilization process and related equipment and facilities for sterile products Realization confirmation evaluation of basic safety and basic performance of active medical devices In vitro diagnostic reagent production process Process parameters and batch amplification verification.

4.5.6 packing term of validity Reuse The applicant shall inspect the product packaging Carry out research and keep relevant records on validity period or repeated use times, etc,as Product packaging design and packaging integrity verification Stability study data Design records of product specifications and minimum sales unit labels, etc.

4.5.7 Verification record Detailed original data records of design and development verification activities shall be maintained,Include validation protocol Validation report Verification record Such as test data Sample handling records, etc Auxiliary records, etc.

4.5.8 Clinical confirmation During design and development validation,If the registered product needs to be confirmed by clinical trial,The applicant shall perform corresponding duties in accordance with the clinical trial plan and the contract,And keep relevant documents and records.

4.5.9 Requirements for clinical trial products Products for clinical trials,Before clinical trial start,The applicant shall ensure that the product design is finalized and the product inspection has been completed,Its security Functional for clinical trials,Keep records of relevant assessment and validation processes.

4.5.10 Clinical trial product management The applicant shall track and manage the prototype for the test in the whole process/Distribution of products storage and transportation recovery/Return, etc,And keep relevant records.

4.5.11 Design and development changes Design and development changes including product changes Reference file update Changes to design transformations Such as equipment Raw material supplier workmanship Environment, etc Change request from outside test Animal experiment Clinical trials Technical review change comments Changes caused by changes in mandatory medical device standards, etc,Should be subject to risk assessment Verification or confirmation,Ensure changes are controlled.

4.5.12 Entrusted R & D management On the existence of entrusted R & D Development case,The applicant shall have quality management measures for relevant activities.

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