Introduction: No rules can not make Fiona Fang, so how to write the quality management standard of medical device technical review? Next, I bring you the collected articles, welcome to read!
Model Quality Management Standard for Technical Review of Medical Devices Chapter I General Provisions
Article 1 In order to further improve the quality of technical review of medical devices and ensure that the technical review of medical devices is legal, scientific, efficient and fair, according to the State Council's Opinions on Reforming the Examination and Approval System of Medical Device Review (Guo Fa [201*] No.44), Regulations on the Supervision and Administration of Medical Devices (the State Council Order No.650) and Measures for the Administration of Medical Device Registration (China Food and Drug Administration),
Article 2 The Medical Device Technology Evaluation Center of China Food and Drug Administration (hereinafter referred to as the evaluation center) shall, in accordance with the requirements of this specification and in combination with the actual situation of the evaluation work, formulate corresponding quality policies and quality objectives, establish and improve a quality management system suitable for the evaluation work, and ensure its effective operation.
Article 3 The center shall, in combination with its own work practice, constantly evaluate the internal system and mechanism, gradually innovate the technical review mode of medical devices, adjust and optimize the review process, enhance the ability of the review team, rationally allocate the review resources, improve various management systems, and continuously improve the quality of the review work.
Article 4 Risk management shall run through the whole process of technical review of medical devices, analyze, identify and evaluate risk points in the process of work, and formulate risk control measures in a targeted manner.
Article 5 All staff of the Center shall enhance their awareness of quality management, earnestly perform their duties, give full play to their subjective initiative, and ensure the effective operation of the quality management system for technical review of medical devices.
Chapter II Examining Departments and Duties
Article 6 A management department suitable for the technical review of medical devices shall be established, and the responsibilities and authorities of leaders at all levels and departments shall be defined, with clear responsibilities and rights.
Article 7 The main person in charge of the center is the main person in charge of the technical evaluation quality of medical devices, and performs the following duties:
(a) to organize the formulation of the quality policy and quality objectives of the center to ensure the effectiveness of the operation of the quality management system;
(2) Funds, human resources, infrastructure and working environment needed to ensure the effective operation of the quality management system;
(three) to organize the implementation of management review, regularly evaluate the operation of the quality management system of medical device technical review, and promote continuous improvement;
(4) Emphasis on process method and risk awareness in quality management of medical device technical review.
(five) in strict accordance with the requirements of relevant laws, regulations and rules to organize the implementation of medical device technology review, to ensure the effective integration of quality management system and business work, and achieve the expected results.
(six) to ensure that the procedures and technical requirements related to the technical review of medical devices are clear and consistent, and the review information is open and transparent.
(seven) support and promote the leadership of the relevant departments in the center to play a leading role within the scope of their duties; Pay attention to the ability training of technical examiners and improve the quality and efficiency of technical examination.
Article 8 The main person in charge of the center shall designate the person in charge of quality management to be responsible for establishing, implementing and maintaining the effective operation of the quality management system. Be responsible for reporting the operation and improvement requirements of the quality management system, and improving employees' understanding of the quality management requirements of technical review.
Article 9 Establish a qualified quality management department for technical review of medical devices, organize the formulation of a quality management system, guide and supervise the implementation of the system, be responsible for the supervision and management of review quality and efficiency, and check, correct and continuously improve the implementation of the quality management system.
Tenth set up qualified medical device technology review departments and posts, responsible for medical device technology review, revision of guiding principles, external consultation and education and training of reviewers. Technical review posts should at least include review, review and distribution posts. Determine the responsibilities and authority of posts at all levels, with clear responsibilities and rights.
Eleventh the establishment of qualified medical device technical review support departments and posts, responsible for the organization of various meetings, fixed assets management, information construction, logistics and other work. Central; Responsible for the acceptance, operation and storage of registration application materials, organizing the review of special approval and priority approval applications for innovative medical devices, the daily management of expert consultation and the preparation of meetings. It provides the necessary guarantee for the orderly development of medical device technical review.
Chapter III Quality Management System Review
Article 12 Formulate the quality policy for technical review of medical devices, and take effective measures to ensure the effective implementation of this policy. The quality policy shall conform to the following principles:
(a) to ensure the safety and effectiveness of public machinery.
(2) Conforming to the provisions of relevant laws and regulations on medical devices.
(3) performing duties according to law.
(4) Providing good services to registered applicants.
Thirteenth according to the functions of the department or post, according to the relevant process of technical review, the quality objectives of technical review of medical devices are formulated, which fully reflects the functional requirements of technical review of medical devices. Quality objectives should:
(a) in line with the deployment of the technical review of medical devices of the General Administration.
(2) Conforming to the quality policy.
(3) Being able to evaluate, evaluate and update in time.
(four) put forward requirements for the quality and efficiency of technical review.
Article 14 All departments of the Center shall formulate quality management sub-objectives according to the quality objectives of the Center and combined with specific functions to ensure the realization of the quality objectives of the Center.
Fifteenth centers and departments should formulate annual objectives and tasks, decompose and refine the annual tasks, and complete them within the required time limit.
Article 16 A corresponding quality management system shall be established according to the specific conditions of technical review of medical devices, and the quality management system shall be planned as a whole according to the quality policy, quality objectives and requirements of this specification. The center should constantly sum up and improve the experience of quality management to meet the needs of technical review of medical devices and promote the continuous improvement of quality management system. The quality management system should be able to continuously and effectively control all the work related to the technical review of medical devices in the center.
Seventeenth medical device technical review quality management system should include the following requirements:
(a) Establish a science and technology review mechanism.
(2) Establish an efficient review workflow.
(three) to provide a sound working system or specification for the technical review of medical devices.
(four) clear responsibilities and authority of personnel in each position.
(five) to determine the monitoring, reporting and handling procedures of nonconformities.
(six) to clarify the evaluation and improvement procedures of technical review of medical devices.
(seven) to determine the internal audit and management review procedures.
Article 18 The quality management system documents for technical review of medical devices shall include: quality manuals, management procedures, and various management methods, regulations, operation specifications, implementation rules and records required to ensure the effective operation of related processes.
The quality manual shall at least include:
(a) the quality policy and quality objectives of the technical review of medical devices.
(2) the scope of application of the quality management system.
(3) Procedures, specifications or document references of the quality management system.
(D) the relationship between the processes of the quality management system.
Chapter IV Examiner Management
Nineteenth according to the needs of the review work, equipped with medical device technical review personnel. Establish management systems such as qualification, training, assessment, qualification identification, post employment and adjustment of assessors to meet post requirements.
Twentieth medical device technical review personnel shall meet the following basic requirements:
(a) abide by professional ethics, fairness and justice, honesty and trustworthiness, integrity.
(two) have a sense of responsibility, complete the tasks on time, and bear the corresponding responsibilities.
(three) to make an objective evaluation of the medical device registration and declaration items, and not to be affected by any illegal interests.
(4) Have good team spirit and communication skills, and be able to express personal views accurately and clearly.
(5) Strictly keep technical and commercial secrets.
Twenty-first assessors should have the corresponding academic qualifications or work background and the ability to complete the assessment independently.
(1) Education or work background
Medical device technical reviewers should have professional education background in clinical medicine, biomedical engineering, biomaterials, toxicology and other medical devices, or have relevant work experience in research and development, production and inspection of medical devices.
(2) Work ability requirements
1. Be familiar with the laws, regulations and rules related to the technical review of medical devices and be able to apply them to the technical review of medical devices.
2. Proficient in the basic knowledge of medical devices related to the position, including medical knowledge related to the use of medical devices, production technology and technical points, quality control, non-clinical evaluation, clinical research, risk assessment and other related knowledge.
3. Use the relevant laws and regulations, science and technology, medical (clinical) knowledge and evaluation experience of medical device registration to comprehensively evaluate the scientificity and completeness of the registration application materials.
4. Make a correct judgment on the intended use, performance, patient benefits and potential risks of registered items, ensure that the remaining risks are acceptable, and ensure that the benefits of listed medical devices outweigh the risks under normal use conditions.
5. Synthesize the opinions of the team, external experts, manufacturers and other medical device regulatory agencies, and make a review conclusion.
6. Have basic information office skills and be familiar with the operation of network, basic office software and evaluation system.
Twenty-second medical device technical reviewers implement classified management, and define the classification requirements, classification standards and job responsibilities of reviewers at all levels.
Article 23 Establish a system of pre-job training and continuing education for reviewers, establish a team of training lecturers around the responsibilities and tasks of medical device technical review, compile course materials at different levels, establish and improve assessment methods, establish a medical device training base, and carry out systematic, professional and multi-level training. New recruits can take part in or review independently only after passing the examination.
Article 24 Establish and properly keep personal files of on-the-job assessors' training, and record personal training hours and assessment results. As an important basis for job recruitment, promotion and performance pay.
Chapter V Management of Technical Review Process
Twenty-fifth according to the requirements of the time and time limit for the transfer to the technical review link, the technical review of the corresponding registered projects shall be carried out in turn. If it is necessary to adjust the review order of registered projects, the starting conditions and required processes should be clearly defined.
Article 26 A unified format shall be formulated for the technical review report of medical devices. The items listed in the review report shall meet the requirements of existing laws and regulations, and the reviewers shall clearly state the contents related to the safety and effectiveness evaluation of the declared products in the review report.
Twenty-seventh make quality requirements for the technical review report of medical devices, and put forward responsibility requirements for posts at all levels involved in the technical review report of medical devices to improve the quality of the review report.
Twenty-eighth registered and declared projects shall be classified according to the complexity, and the classification standard of complexity shall be formulated according to the registration form, management category, product risk and adequacy of evaluation basis.
Twenty-ninth according to the classification of registered applications, determine the allocation principle of evaluation resources, formulate a scientific and reasonable allocation mechanism of evaluation resources, determine a variety of evaluation paths, and clarify the responsibilities of reviewers in each evaluation path.
Thirtieth medical device technical evaluation should consider the collective decision-making mechanism. For new, high-risk, multi-technology complex products, we should set up project evaluation teams according to professional disciplines, fully embody the collective responsibility system, constantly standardize and optimize the evaluation process, and carry out technical evaluation work in a scientific evaluation mode.
Thirty-first to formulate operational specifications for various registered items related to the technical evaluation of medical devices, including registration, registration renewal, registration change, clinical trial approval, instruction manual change notice, medical device registration certificate correction, etc. Each operation specification shall specify the scope of application, workflow, job responsibilities and time limit.
Article 32 The operating specifications of key procedures in the technical review of medical devices shall be formulated, including the operating specifications of quality system verification and start-up, joint review, data correction, suspension of review, rejection of registration and voluntary withdrawal of registered items.
Article 33 An expert advisory committee for technical review of medical devices (review expert committee) shall be established to formulate measures for the management of medical device experts, relevant operational specifications for expert consultation meetings and public demonstration meetings, and define the requirements for the initiation conditions of expert consultation meetings and public demonstration meetings, the post responsibilities and authority of relevant examiners, time limit requirements, and the procedural management of expert consultation meetings and public demonstration meetings.
Article 34 Establish the technical committee system of the medical device technical evaluation center, standardize the composition and functions, topic scope, meeting procedures and meeting requirements of the technical committee, and collectively study and solve the * * * difficult problems encountered in the process of medical device technical evaluation.
Article 35 Operational specifications for technical review of innovative medical devices shall be formulated to regulate the determination of reviewers, early intervention, communication with applicants or registrants, operation in the process of technical review, review time limit requirements, etc.
Article 36. Formulate the operating rules for the technical review of emergency medical devices, and standardize the determination of reviewers, early intervention, communication with applicants or registrants, operation and time limit requirements for the technical review of registration applications entering the emergency examination and approval procedures.
Thirty-seventh formulate the operational specifications for the technical review of priority approval of medical devices, and standardize the operation and review time limit requirements in the process of technical review of registration applications entering the priority approval procedures.
Chapter VI Technical Review Support Process Management
Thirty-eighth formulate the requirements for the acceptance of registration application materials, and clarify the responsibilities and powers, acceptance procedures, working hours, work discipline and acceptance standards of registration application materials.
Thirty-ninth put forward clear requirements for the management of registration application materials, including data reception, registration, preservation, transfer, statistics, borrowing and identification. Clarify the job responsibilities and time limit requirements of each link in the circulation of registration application materials, and form records in each link in the circulation of application materials.
Fortieth, establish standardized and unobstructed consultation channels to ensure effective communication between registered applicants or registrants and medical device technical reviewers.
Article 41 Establish a communication and coordination mechanism between departments to ensure efficient and smooth communication between departments within the center and between the center and relevant external units.
Article 42 The technical review guidelines for medical devices shall be formulated, and the work responsibilities, formulation procedures, opinions collection and publication during the formulation and revision of the technical review guidelines for medical devices shall be standardized.
Forty-third training for registered applicants, improve the quality of registration application materials, standardize the center's external training work, and clarify the training plan, departmental responsibilities, lecture answering, teacher selection and other requirements.
Article 44 The entrusted work in the technical review of medical devices shall be defined, and the entrusted work flow shall be stipulated. Clarify the selection, evaluation and re-evaluation criteria of the trustee, and keep records of the above processes and results. Sign the relevant entrustment agreement with the trustee or specify the work content and requirements it undertakes.
Chapter VII Facilities and Equipment
Forty-fifth with the evaluation task and the number of personnel to adapt to the office conditions. The assessor should have a relatively independent office area, and the consultation reception area of the registered applicant or registrant should be separated from the office area of the assessor.
Forty-sixth equipped with basic office facilities, equipment and personnel commensurate with the evaluation work. Equipped with corresponding meeting rooms, storage rooms for registration application materials and relatively independent special places for consultation and reception. The area, equipment and facilities of each area should meet the use requirements.
Article 47 A review information management system suitable for the technical review of medical devices shall be established. Acceptance, review and approval information system can be effectively connected, and equipped with professional information management personnel for regular maintenance.
Article 48 An information database conducive to the technical review of medical devices shall be established, including databases of laws, regulations, standards, documents and guiding principles. Inquiring methods and obtaining methods of medical device related information in technical review.
Chapter VIII Document Management
Article 49 A document management procedure shall be established and the following requirements shall be specified:
(1) Requirements for drafting, modifying, reviewing, approving, copying, saving and destroying documents.
(two) when the document is updated or revised, it should be reviewed and approved according to the regulations, and the status of the document change and revision can be identified.
(three) the distribution and use of documents should be appropriate texts, and the documents that have been revoked or invalidated should be marked to prevent misuse.
Article 50 The requirements for the management of foreign documents shall be clarified, including the requirements for the identification, signing, control, distribution, storage and destruction of documents.
Article 51 Establish records management procedures, including requirements for record identification, storage, retrieval, retention period and disposal, including:
(1) Records shall ensure the traceability of activities such as technical review and quality control of medical devices.
(two) records should be clear and complete, easy to identify and retrieve, to prevent damage and loss.
Chapter IX Quality Control and Improvement
Article 52 The technical review of medical devices shall establish a supervision and inspection mechanism, collect and analyze relevant data of processes and results, promote continuous improvement and improve the quality of review.
Article 53 The technical review of medical devices shall be evaluated and verified, and the evaluation and verification standards shall be formulated, specifying the specific methods, contents, frequency and corresponding post responsibilities.
Article 54 Establish corresponding management procedures for situations that do not meet the job requirements, manage the processes and results that do not meet the job requirements, and clarify the classification requirements, handling methods (including accountability), records generated during handling, and responsibilities and authorities of relevant departments or personnel.
Article 55 Measures for supervision and management shall be formulated, and the responsibilities and powers, work scope, work procedures, processing time limit and relevant record requirements of each department in supervision work shall be defined.
Article 56 An internal audit procedure shall be established to specify the audit criteria, scope, frequency, participants, methods, records, corrective and preventive measures, etc., so as to ensure that the quality management system meets the requirements of this specification.
Fifty-seventh regular management review and evaluation of the quality management system, to ensure its continued suitability, adequacy and effectiveness.
Article 58 Establish a management procedure for corrective measures, take effective measures to eliminate the reasons that do not meet the work requirements, and prevent similar phenomena from happening again, so as to realize the continuous improvement of the quality management system.
Article 59 Establish information feedback management procedures, specify the sources, collection methods, summary, statistics, analysis and processing methods of feedback information, and clarify the functions of relevant posts and personnel.
The feedback information includes the guidance of the superior unit to the work of the center, the opinions and suggestions of the applicant or registrant on the technical review of medical devices, and whether the quality of technical review meets the requirements of quality management system, laws and regulations and clean government work.
Sixtieth open the feedback, complaints and reporting channels of the applicant or registrant. When receiving information feedback, complaints or reports related to the technical review of medical devices, it shall record, analyze and deal with relevant matters in a timely manner.
Article 61 According to the provisions of the central government and the relevant decision-making centers of the State Food and Drug Administration, identify and evaluate the credit risk factors that the center can control and influence. Equipped with anti-corruption management related organizations, clear the responsibilities of anti-corruption management related personnel.
Sixty-second regular training activities related to clean government education, improve the awareness of clean government and risk prevention and control ability of technical reviewers. Establish a clean government responsibility system and improve the ability to prevent clean government risks. Clean government responsibility should include requirements for central leaders, department heads and ordinary technical examiners.
Sixty-third formulate measures to investigate the responsibility of clean government, and standardize the responsibilities, document requirements, disposal procedures and other contents of leaders at all levels of the center when there is a problem of clean government in the technical review.
Chapter X Supplementary Provisions
Article 64 The meanings of the following terms in this Law are:
Technical review of medical devices: refers to the process of systematically evaluating the safety and effectiveness research and its results of medical devices to be listed according to the application made by the applicant or registrant of medical devices and legal procedures, putting forward conclusive opinions and issuing corresponding technical review reports.
Reviewer: refers to the person who conducts technical review on the safety and effectiveness of the medical device products applied for registration.
Documents: the systems, information, data and their carrying media formed in the technical review of medical devices to standardize or guide the technical review, including management procedures, administrative regulations, technical documents, reports, charts and records, etc.
Article 65 The Medical Device Technology Evaluation Center of China Food and Drug Administration shall be responsible for the interpretation of this specification.
Article 66 These Standards shall come into force as of the date of promulgation.
;