Recently, the Medical Device Technical Evaluation Center of the General Administration of the People's Republic of China issued a notice on the "Quality Management Standards for Medical Device Evaluation (Trial)". The formulation of the "Code" aims to implement the "Opinions of the State Council on Reforming the Examination and Approval System for Drug Medical Devices" (Guo Fa [2015] No. 44), further improve the quality and efficiency of medical device technology review work, and promote the review work. Standardized and institutionalized.
Attached to the quality management standard for medical device technical review (trial)
Chapter I General Provisions
Article 1 In order to further improve the quality of medical device technology review work, and ensure that medical device technology review work is legal, scientific, efficient and fair, according to the "Opinions of the State Council on Reforming the Approval System for Drug Medical Device Evaluation" (Guo Fa [2015] No. 44), Regulations on the Supervision and Administration of Medical Devices (Order No. 650 of the State Council), Measures for the Administration of Registration of Medical Devices (Order No. 4 of the State Food and Drug Administration), and Measures for the Administration of Registration of In Vitro Diagnostic Reagents (National Foods) The General Administration of Drug Administration, Order No. 5), this specification is formulated with reference to the general principles of GB/T 19001 “Quality Management System Requirementsâ€.
Article 2 The Medical Device Technical Evaluation Center (hereinafter referred to as the Center) of the State Food and Drug Administration shall, in accordance with the requirements of this Code, combine the actual conditions of the review work, formulate corresponding quality policies and quality objectives, and establish and improve the work in accordance with the review work. Quality management system and ensure its effective operation.
Article 3 should continuously evaluate the internal system and mechanism in light of its own work, gradually innovate the medical device technology review model, adjust and optimize the review process, enhance the review team's ability, rationally allocate review resources, and improve various management systems. , continuously improve the quality of the review work.
Article 4: Risk management shall be carried out throughout the whole process of medical device technical review work, and the risk points in the work process shall be analyzed, identified and evaluated, and risk control measures shall be formulated 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 medical device technology review.
Chapter II Review Department and Responsibilities
Article 6 Establish a management department that is compatible with the medical device technical review work, and clarify the responsibilities and authorities of leaders and departments at all levels, with clear responsibilities.
Article 7 The principal person in charge of the center is the main responsible person for the quality of medical device technology review and shall perform the following duties:
(1) Organizing the quality policy and quality objectives of the center to ensure the effectiveness of the operation of the quality management system;
(2) Funding, human resources, infrastructure and working environment required to ensure the effective operation of the quality management system;
(3) Organizing the implementation of management review, regularly evaluating the operation of the medical device technical review quality management system, and promoting continuous improvement;
(4) Emphasis on process methods and risk awareness in the quality management of medical device technology review work.
(5) Organizing and implementing the medical device technical review work in strict accordance with the requirements of relevant laws, regulations and rules to ensure the effective integration of the quality management system and business work, and achieve the expected results.
(6) Ensure that the procedures and technical requirements related to the medical device technical review are clear and consistent, and the review information is open and transparent.
(7) Support and promote the responsible persons of relevant departments within the center to play a leading role within the scope of their duties; focus on the training of technical reviewers' ability to improve the quality and efficiency of technical review work.
Article 8 The principal responsible person of the center shall appoint the person in charge of quality management to be responsible for establishing, implementing and maintaining the effective operation of the quality management system. Responsible for reporting the operation of the quality management system and improving the requirements, and raising the awareness of the quality management requirements of the staff technical review.
Article 9 Establish a medical device quality evaluation quality management department that meets the requirements, organize the formulation of a quality management system, guide and supervise the implementation of the system, be responsible for reviewing the quality and efficiency of the supervision and management, and check the implementation of the quality management system. , corrective and continuous improvement.
Article 10 Establish Medical Equipment technical review departments and jobs that meet the requirements, and be responsible for medical device technical review, guiding principles revision, external consultation and evaluation of educators. The technical review position shall include at least the review, review and issuance of posts. Determine the responsibilities and authorities of positions at all levels, and the responsibility is clear.
Article 11 Establish medical equipment technical review support departments and positions that meet the requirements, be responsible for all kinds of conference organization, fixed asset management, information construction, logistics support, etc.; be responsible for the acceptance, operation and custody of registration application materials, and organize Conduct special examination and approval of innovative medical devices, review of priority approval applications, daily management of review expert consultations, and preparations for meetings. Provide necessary safeguards for the orderly development of medical device technology review work.
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