Medical device technical review of quality management specification model
Introduction: no rules are not round, so how to write about the medical device technical review of quality management specification? The next is the article I brought you to collect and organize, welcome to read! 201*] No. 44), "Regulations for the Supervision and Administration of Medical Devices" (State Council Decree No. 650), "Measures for the Administration of Registration of Medical Devices" (State Food and Drug Administration Decree No. 4), "Measures for the Administration of Registration of In Vitro Diagnostic Reagents" (State Food and Drug Administration Decree No. 5), with reference to the general principles of the GB/T 19001 "Quality Management System Requirements" to formulate the specifications.
Article 2 The State Food and Drug Administration Medical Device Technical Review Center (hereinafter referred to as the Center) shall, in accordance with the requirements of this specification, combined with the actual situation of the review work, the development of the appropriate quality policy, quality objectives, the establishment of a sound quality management system compatible with the review work, and to ensure its effective operation.
Article 3 The center should combine its own work, constantly evaluate the internal system and mechanism, gradually innovate the medical device technical review model, adjust and optimize the review process, enhance the ability of the review team, rational allocation of review resources, improve the management system, and continuously improve the quality of the review work.
Article IV will be risk management throughout the entire process of technical review of medical devices, the risk of the work process to analyze the identification and evaluation, targeted development of risk control measures.
Article 5 All staff of the center should enhance the awareness of quality management, conscientiously fulfill their responsibilities, give full play to the subjective initiative to ensure the effective operation of the quality management system for the technical review of medical devices.
Chapter II review department and responsibilities
Article 6 The establishment of the management department with the medical device technical review work, clear leadership at all levels and the duties and responsibilities of the various departments, clear responsibilities and powers.
Article 7 The center is the main person responsible for the quality of the technical review of medical devices, should perform the following duties:
(a) organization to develop the center's quality policy and quality objectives, to ensure the effectiveness of the operation of the quality management system;
(b) to ensure that the quality management system for the effective operation of the funds required, human resources, infrastructure and working environment;
(C) organization and implementation of management review, regular assessment of the operation of the quality management system for the technical review of medical devices, and promote continuous improvement;
(D) in the technical review of medical devices in the quality management process emphasizes the process approach and risk awareness.
(e) Strictly in accordance with relevant laws, rules and regulations to organize and implement the technical review of medical devices, to ensure that the quality management system and the effective integration of business work, and to achieve the desired results.
(F) to ensure that the technical review of medical devices related procedures and technical requirements are clear and consistent, review information open and transparent.
(vii) Support and promote the leadership of all relevant department heads within the Center within their scope of responsibilities; focus on the competence training of technical reviewers to improve the quality and efficiency of the technical review process.
Article VIII of the center shall be appointed by the person in charge of quality management, responsible for the establishment, implementation and maintenance of the effective operation of the quality management system. Responsible for reporting on the operation of the quality management system and the need for improvement, to improve the awareness of the staff of the quality management requirements of the technical review.
Article IX established to meet the requirements of the medical device technical review quality management department, the organization to develop quality management system, guidance, supervision and implementation of the system, responsible for the review of the quality and efficiency of supervision and management, and the implementation of the quality management system for inspection, correction and continuous improvement.
Article 10 to establish the requirements of the medical device technical review departments and jobs, responsible for the technical review of medical devices, guidelines for the preparation and revision of external consulting and reviewer education and training. Technical review positions should at least include review, review, issue positions. Determine the duties and responsibilities of the positions at all levels of authority, responsibility and authority clear.
Article 11 The establishment of the requirements of the technical review of medical devices to support the department and position, responsible for the center of the organization of various meetings, fixed asset management, information technology, logistics and other work; responsible for the acceptance of the registration declaration information, operation and custody, the organization of innovative medical devices, special approval, priority approval of the application for the review of the review of the work of expert advice, review of the day-to-day management and preparation for the meeting. To provide the necessary protection for the orderly development of the technical review of medical devices.
Chapter III Review of quality management system
Article 12 of the development of medical device technical review of the quality policy, and take effective measures to ensure that the policy is effectively implemented. The quality policy shall be consistent with the following principles:
(a) To ensure that the public use of devices is safe and effective.
(B) in line with medical device-related laws and regulations.
(C) fulfillment of work responsibilities in accordance with the law.
(D) to provide good service to the applicant for registration.
Article 13 According to the department or post functions, for the technical review of the relevant process to develop quality objectives for the technical review of medical devices, fully reflecting the functional requirements of the technical review of medical devices. Quality objectives should be:
(a) consistent with the General Administration of medical device technical review work deployment.
(B) consistent with the quality policy.
(C) can be assessed, evaluated and updated in due course.
(d) Requirements for the quality and efficiency of the technical review process.
Article 14 The center's departments shall formulate quality management sub-targets according to the center's quality objectives and in conjunction with specific functions to ensure the realization of the center's quality objectives.
Article 15 The center and the departments shall formulate annual objectives and tasks, decompose and refine the annual tasks, and complete them within the time limit as required.
Article 16 According to the technical review of medical devices to establish a corresponding quality management system, according to the quality policy, quality objectives and the requirements of the specification of the quality management system for the overall planning. The center should continue to summarize and improve the quality management experience, to adapt to the needs of medical device technical review work, and promote the continuous improvement of the quality management system. Quality management system should be able to center for the technical review of medical devices related to the implementation of continuous and effective control of the work.
Article 17 of the quality management system for the technical review of medical devices should include the following requirements:
(a) the establishment of a scientific technical review mechanism.
(B) the establishment of efficient review workflow.
(C) for the technical review of medical devices to provide a perfect working system or standardization.
(D) Clearly define the duties and responsibilities of each position.
(E) Determine the monitoring, reporting and handling procedures for non-compliance.
(F) Define the evaluation and improvement procedures for the technical review of medical devices.
(VII) to determine the internal audit, management review process.
Article 18 of the quality management system for the technical review of medical devices documents should include: quality manual, management procedures, and to ensure the effective operation of the relevant processes required for the management of the methods, regulations, operating practices, implementation details and records.
The quality manual shall include at least:
(a) the quality policy and quality objectives of the technical review of medical devices.
(B) the scope of application of the quality management system.
(C) for the quality management system to document the procedures, specifications or references.
(d) A statement of the interrelationships between the processes of the quality management system.
Chapter IV review personnel management
Article 19 According to the review of the need to be equipped with the appropriate technical review of medical devices. The establishment of review personnel conditions of service, training, assessment, accreditation, post employment and adjustment of the management system to meet the job requirements.
Article 20 The technical review of medical devices shall comply with the following basic requirements:
(a) abide by professional ethics, fairness and impartiality, honesty and integrity.
(B) have a sense of responsibility, complete the tasks on time, and bear the corresponding responsibility.
(3) To make an objective assessment of the medical device registration program, without the influence of any illegal interests.
(4) Good team spirit, communication skills, and the ability to accurately and clearly articulate personal views.
(e) Strictly abide by technical and commercial secrets.
Article 21 The reviewers shall have the educational or working background appropriate to the job, and the ability to independently complete the review.
(A) education or work background
Medical device technical reviewers should have clinical medicine, biomedical engineering, biomaterials, toxicology and other medical device-related professional education background, or with medical device research and development, production, testing and other related work experience.
(B) the ability to work requirements
1. Proficiency in the technical review of medical devices related laws, rules and regulations, and be able to apply them to the technical review of medical devices.
2. Proficiency in the basic knowledge of medical devices related to responsibilities, including: medical knowledge related to the use of medical devices, production processes and technology, quality control, non-clinical evaluation, clinical research, risk assessment and other related knowledge.
3. Utilizing medical device registration related laws and regulations, science and technology, medical (clinical) knowledge and review work experience on the scientific and comprehensive evaluation of registration data.
4. To declare the expected use of the project registration, performance, patient benefits and potential risks to make a correct judgment, to ensure that the residual risk is acceptable, to ensure that the listed medical devices in the normal use of the conditions of the patient's benefit is greater than the risk.
5. Synthesize the opinions of the team, external experts, manufacturers and other medical device regulatory agencies to make the review conclusion.
6. Have the basic ability of information technology office, proficiency in network, basic office software and the operation of the review system.
Article 22 of the medical device technical review staff for grading management, clear grading requirements, grading standards and review staff at all levels of responsibility.
Article 23 The establishment of pre-training and continuing education system for reviewers, the responsibilities and tasks around the technical review of medical devices, the establishment of training instructors, the preparation of course materials at different levels, the establishment of a comprehensive assessment and evaluation methods, the establishment of medical device training bases, to carry out systematic, specialized, multi-level training. The new recruits can only participate in or independently review after passing the assessment.
Article 24 The establishment and proper preservation of on-the-job review of personnel training personal files, records of personal training hours, assessment results, etc., as an important basis for job employment, promotion, performance pay.
Chapter V Technical Review Process Management
Article 25 According to the transfer to the technical review of the session time and time limit requirements of the categories, according to the order of the corresponding registration of the project to carry out the technical review. If there is a need to adjust the order of the review of the registration of the project, should be initiated conditions, the process required to be clear.
Article 26 The development of a unified format for the technical review of medical devices report, the review of the items listed in the report should be consistent with the current regulatory requirements, the reviewers should be involved in the review of the report on the declaration of the product safety, efficacy evaluation of the contents of the report to be clearly expressed.
Article 27 of the technical review of medical devices to make quality requirements for the report on the technical review of medical devices involved in the report at all levels of responsibility requirements, to improve the quality of the review report.
Article 28 of the registration of the reporting project in accordance with the complexity of grading management, according to the form of registration, management category, product risk, review of the adequacy of the basis for the development of complex grading standards.
Article 29 According to the grading of the registration application program to determine the allocation of review resources, the development of scientific and reasonable mechanism for the allocation of review resources, to determine a variety of review paths, a clear review path in the responsibilities of the reviewers.
Article 30 The technical review of medical devices should consider the collective decision-making mechanism, for new, high-risk, multi-technology composite products, such as key products, should be set up in accordance with the professional disciplines of the project review team, the full embodiment of the collective responsibility system, and constantly standardize and optimize the review process, to carry out the technical review work in a scientific review mode.
Article 31 of the technical review of medical devices related to the various types of registration reporting matters to develop operational standards, including registration, renewal of registration, registration changes, clinical trial approval, instructions to change the notification and correction of errors in the certificate of registration of medical devices. The operation specification should be applied to the scope of work, workflow, job responsibilities and time limits to be clear.
Article 32 of the technical review of medical devices in the process of developing key procedures, including the application for registration of the project quality system verification of the start, joint review, corrective information, suspension of the review, non-registration and self-withdrawal of the work of the operational norms.
Article 33 The establishment of medical device technical review of the Expert Advisory Committee (review of the Expert Committee), the development of medical device expert management and expert consultation, public hearings related to the operation of the norms of the expert consultation, public hearings on the conditions for the launch of the review of the relevant review of the position of personnel and authority, time requirements, expert consultation, public hearings, such as the management of the program requirements to be clear. Clearly.
Article 34 The establishment of the Medical Device Technical Review Center Technical Committee system, the composition and functions of the Technical Committee, the scope of issues, meeting procedures and meeting requirements, etc., to standardize the technical review of medical devices encountered in the process of the *** difficult collective research to solve the problem.
Article 35 The development of innovative medical devices technical review of the operating norms, innovative medical devices into the special approval process of the product in the review of the determination of personnel, pre-intervention, communication with the applicant or registrant, the operation of the technical review process and the review of the time limit for the standardization of content.
Article 36 The development of emergency medical device technical review specifications for emergency approval procedures for the registration application program in the review of personnel to determine the pre-existing intervention, communication with the applicant or registrant, the technical review of the process of `operation and review of the time limit requirements and other content to standardize.
Article 37 The development of medical device priority approval of the technical review of the operational specifications for priority approval procedures for registration applications into the process of technical review of the project operation and review of time requirements and other content to standardize.
Chapter VI Technical Review Support Process Management
Article 38 The development of registration requirements for the acceptance of information, clear acceptance of the responsibilities and authority of the personnel, acceptance of the procedures, time limits, work discipline and the receipt of registration information standards.
Article 39 Clearly on the registration of information management requirements, including information reception, registration, preservation, transfer, statistics, borrowing, labeling and so on. Clearly registered to declare the flow of information in all aspects of job responsibilities, time requirements, and in the flow of information to form a record in the various aspects of the declaration.
Article 40 targeted to establish a standardized, smooth channels of consultation to ensure that the applicant for registration or the registrant and the effective communication of medical device technical reviewers.
Article 41 The establishment of inter-departmental communication, coordination mechanism to ensure that the center of the internal departments, the center and external communication between the relevant units of efficient and smooth.
Article 42 The development of medical device technical review guidelines for the formulation and revision of norms on the formulation and revision of guidelines for the technical review of medical devices in the process of job responsibilities, the development process, the collection of views and publication of the release of norms and other work.
Article 43 of the registration of personnel training, to improve the quality of registration information, standardize the center of external training, clear training programs, departmental responsibilities, teaching and Q&A and teacher selection requirements.
Article 44 of the technical review of medical devices commissioned to clarify the work and make provisions for the commissioning process. Define the selection, evaluation and re-evaluation guidelines of the entrusted party, and keep records of the above process and results. Sign the relevant commissioning agreement with the delegated party or clarify the content and requirements of the work undertaken by the delegated party.
Chapter VII Facilities and Equipment
Article 45 has office conditions appropriate to the task of the review and the number of personnel. Reviewers should have a relatively independent office area, registered applicants or registrants consulting reception area should be separated from the reviewers office area.
Article 46 is equipped with basic office facilities and equipment appropriate to the review tasks and the number of personnel. Equipped with the appropriate conference room, registration and declaration data storage room and relatively independent of the consultation and reception of special places, the area of the region, equipment and facilities and other conditions should be able to meet the needs of use.
Article 47 The establishment of the review of medical devices to adapt to the technical review of the review of information management systems, acceptance, review and approval of the information system can be realized between the effective docking, equipped with professional information management personnel to carry out regular maintenance.
Article 48 The establishment of a database of information conducive to the technical review of medical devices, including: laws and regulations, standards, literature, guidelines and other databases. For the technical review of medical devices to provide information on the query channel and access.
Chapter VIII Document Management
Article 49 The establishment of document management procedures, the following requirements:
(a) the drafting of documents, revisions, review, approval, copying, storage, destruction and other requirements.
(2) When documents are updated or revised, they should be reviewed and approved in accordance with the provisions, and be able to identify the status of changes and revisions to the documents.
(C) the distribution and use of documents should be appropriate text, has been withdrawn or canceled documents should be labeled to prevent misuse.
Article 50 clearly define the requirements for the management of external documents, including the identification of documents, signature transfer, control, distribution, storage and destruction requirements.
Article 51 establishes record management procedures, including record labeling, storage, retrieval, retention period and disposal requirements, including:
(a) Records should be to ensure that the technical review of medical devices, quality control and other activities of traceability.
(b) Records should be clear, complete, easy to identify and retrieve, to prevent damage and loss.
Chapter IX Quality Control and Improvement
Article 52 for the technical review of medical devices to establish a mechanism for supervision and inspection of the process and results of the collection and analysis of relevant data for continuous improvement to improve the quality of the review process.
Article 53 shall be the medical device technical review of the work of assessment, verification, assessment, verification standards and specify the specific manner, content, frequency and the corresponding job responsibilities.
Article 54 The establishment of the relevant management procedures to deal with non-compliance with work requirements, non-compliance with the work requirements of the program and the results of management, clear classification of non-compliance with the work requirements, processing (including accountability), processing of records generated in the process, the relevant departments or personnel responsibilities and authority requirements.
Article 55 The development of supervision management methods, clear supervision of the work of each department's responsibilities and powers, scope of work, work procedures, processing time and related record requirements.
Article 56 The establishment of internal audit procedures, audit guidelines, scope, frequency, participants, methods, records, corrective and preventive measures required to ensure that the quality management system meets the requirements of this specification.
Article 57 Regular management review, evaluation of the quality management system to ensure its continued suitability, adequacy and effectiveness.
Article 58 The establishment of corrective action management procedures, to take effective measures to eliminate the causes of non-compliance with the work requirements, to prevent the recurrence of similar phenomena, in order to achieve continuous improvement of the quality management system.
Article 59 The establishment of information feedback management procedures, clear sources of feedback information, collection methods, summarization, statistics, analysis and processing methods and other requirements, related positions and personnel functions are defined.
Feedback information includes the higher unit of guidance on the work of the center, the applicant or registrant of the medical device technical review of the work of the comments and suggestions, technical review of the quality of work to meet the requirements of the quality management system, laws and regulations, and integrity of the work of the information requirements.
Article 60 public applicants or registrants feedback, complaints and reporting channels, when receiving medical device technical review of information related to feedback, complaints or reports, should be recorded, analyzed and processed in a timely manner.
Article 61 According to the central and the State Food and Drug Administration relevant policies to develop the center of integrity management regulations, identify and evaluate the center can control and can influence the integrity of the risk factors. Equipped with organizations related to integrity management, and clarify the duties of personnel related to integrity management.
Article 62 Regularly organize training activities related to integrity education to improve the integrity of technical review staff and risk prevention and control awareness. The establishment of the integrity responsibility system to improve the ability to prevent integrity risks, integrity responsibility should include the center's leadership, department heads and ordinary technical review staff requirements.
Article 63 The development of integrity accountability measures, the technical review of personnel related to integrity issues, the center's leadership at all levels of responsibility, documentation requirements, disposal procedures and other content to regulate.
Chapter X Appendices
Article 64 The meaning of the following terms of this specification:
Medical device technical review: refers to the applicant for registration of medical devices or registrant application, in accordance with the statutory procedures, the proposed listing of medical devices on the safety, efficacy of the study and the results of the systematic evaluation process. The process, put forward the concluding observations, and issue the corresponding technical review report.
Reviewers: refers to the application for registration of medical devices for the safety and effectiveness of the technical review of personnel.
Documentation: the technical review of medical devices formed in the work of technical review, used to regulate or guide the technical review of the system, information, data and its carrier media, including management procedures, administrative regulations, technical documents, reports, charts, records and so on.
Article 65 This specification by the State Food and Drug Administration Medical Device Technical Review Center is responsible for the interpretation.
Article 66 This specification shall come into force on the date of publication.
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