2018 Tasks for Device Registration Management Tasks

In March 22nd, 2018, the medical network was an in-depth study of the spirit of the party's Nineteenth Congress. The year of comprehensive deepening reforms was to deepen the reform of the examination, approval and approval system for medical devices, and fully implement the '13th Five-Year' National Drug Safety Plan. The key year of the report. The reporter learned from the National Medical Device Supervision and Management Conference held in Shanghai on March 19 that in 2018, a series of medical device registrations will be established around the goal of ensuring that the masses use high-quality, high-performance medical devices. Management tasks will be substantially promoted.

According to reports, the overall train of thought for the medical device registration management in 2018 is: In-depth study and implementation of the spirit of the Nineteenth National Congress of the Communist Party of China; drug Supervision and Management and the Work Arrangement for the Construction of the Party's Work Style and the Construction of Clean Government, Conscientiously Implementedmedical instruments Supervision and Management Regulations (hereinafter referred to as the "Regulations"), "The 13th Five-Year National Drug Safety Plan", "Opinions on Reforming the Examination and Evaluation System for Pharmaceutical Devices," and "The Deepening of the Review and Approval System, Encouraging the Innovation of Drugs and Medical Devices" Opinions (hereinafter referred to as “Innovative Opinions”) require strengthening the building of laws and regulations and capacity building for registration management, deepening the reform of the review, review and approval system, encouraging innovative R&D of medical devices, and continuously improving the level of medical device registration management.

The meeting made it clear that in 2018, the medical device registration management will thoroughly implement the “Innovative Opinions” and do a good job of amending the “Regulations”, focusing on the implementation of the licensing system for holders of medical device marketing. enterprise It is the consciousness of the responsible body responsible for quality and safety, and clearly defines the legal responsibility of the holder for product design and development, clinical trials, and the whole life cycle. In-depth research is gradually carried out on national unified review, clinical evaluation of medical devices, etc. After the case was formally released, it was necessary to urgently revise the "Measures for the Registration of Medical Devices" and other supporting regulations. Any inconsistency with the "Regulations" and inconsistent with the Regulations shall be amended or repealed. Regulations governing the revision of the guidelines for the technical review of medical devices shall be formulated, Organize and revise 40 guidelines for technical review of medical device registration. Continue to organize medical device registration Regulation Training.

The meeting requested that all localities should actively support and participate in the work on the revision of laws and regulations, strengthen the dissemination of regulations and rules and regulations for medical device registration management, and supervise and inspect the implementation of laws and regulations.

The reporter was informed at the meeting that this year, the reform of the examination, approval and approval system for medical devices will establish a more scientific review and approval system, encourage research and innovation, meet clinical needs, improve clinical evaluation requirements, and strengthen more on-site inspections.

Strengthen the review of quality management system and optimize the approval process. The meeting was clear. In 2018, the full implementation of medical device review quality management standards, the medical device review quality management system will be established and extended to various provincial review institutions, thus exploring the establishment of a national Medical Device Review Quality Management System. Achieve review of Type II medical device products standard And the harmonization of regulations, and the use of file review, internal audit, user feedback, and management review mechanisms to regularly perform performance assessments of review quality and efficiency.

Encourage R&D and innovation to meet urgent clinical needs This year, the “Special Approval Procedure for Medical Device Innovations” will be revised and revised, and the revised "Approval Procedure for Review of Special Medical Device Approval Applications" and "Approval Code for Audit Application for Priority Approval of Medical Devices (Trial)" will be revised. Reduce and reduce the number of procedures, implement special review and approval for innovative medical devices; prioritize and approve projects for priority in the process of technical evaluation and administrative approval. Improve the system for review, approval, and approval of clinical medical equipment in urgent need. The clinical urgently needed medical device conditionally approves the review of the listing operation specification and the guiding principles for registered technical review, refines the requirements for filing information, and establishes a priority channel for review and approval.

Improve clinical evaluation requirements, strengthen on-site inspections This year will amend the "Guiding Principles for Clinical Evaluation of Medical Devices", study and draft "Regulations for the Administration of Medical Device Expandable Clinical Trials", and promote the promotion of the "Administrative Conditions and Record Management of Medical Device Clinical Trial Organizations" Implement and train medical institutions and relevant organizations to use the medical device clinical trial institution's filing management information system as soon as possible to record. Organize and carry out the "medical device clinical trial quality management standard" (hereinafter referred to as 'medical device GCP') training, establish medical device GCP Inspector team. Intensify the supervision and inspection of clinical trial institutions and clinical trial projects. Study and formulate guidelines for verification of registration systems, organize supervision and inspection of registered applications, supervise and inspect the authenticity of testing samples and clinical trial samples, and registration information and actuals. R & D and production consistency.

The meeting requested that all localities actively promote the reform of the review, approval and approval system for medical devices, continue to strengthen the review, review and approval of capacity building, strictly complete the on-site verification of the registration system according to time limits, and strengthen the supervision of clinical trial institutions and pilot projects. Man, severely punishes criminal offenses.

The reporter learned that this year will continue to promote the basic work of registration management of medical device standards, classification, naming, and coding. The first is to strengthen the management of standard projects and the work of system revision. Related to major basic standards, high-risk product standards, and strategic emerging industries Field standards are given priority, and the number of general basic standards, method standards, and management standards are revised. Organizations have to carry out about 100 standard system revision tasks, carry out industry standards evaluation work, and improve the optimization criteria system. Second, continue to promote the reform of classified management. Organize and guide the training of the Catalogue of Medical Devices (herein referred to as the “Catalogue”), do a good job of the implementation of the Catalogue, and strengthen supervision and inspection. In response to past non-standardized approval of products, organize and formulate corresponding treatment measures according to categories, and correct and standardize them. The third is to substantially promote the coding of medical devices. Organize the establishment of unique identification system rules and related standards, and gradually establish a medical device identification database. Fourth is to strengthen naming management. Organize the development of implanted devices and other guidelines for the naming of medical device naming guidelines. Formulate guidelines for implementing terminology Policy.

The implementation of medical device standards supervision is the most important task. The meeting emphasized that all localities should strengthen the promotion and supervision of medical device standards, classification, coding and naming work in their administrative areas. The implementation of the standard is scientific and reasonable, and it is prudent to grasp the applicability of handling recommended standards and the guiding principles of registered technical review, and strictly implement the classification rules and naming rules for medical devices, and do a good job of the implementation of the Catalogue.

The topic of 'smart supervision' was widely discussed at the meeting. The reporter learned that the supervision department will study the establishment of a unified online reporting platform for the review, approval and approval of medical devices to achieve the electronic submission of registration applications and the review and approval of approvals; , Based on the implementation of e-filing, building product registration application information files and product registration approval information files; Actively innovate, review product review conclusions first and open on the basis of all information; Strengthen registered product database management, standardize data formats, Registration data is submitted to the data sharing platform in a unified manner to realize data interconnection and improve data utilization.

The meeting demanded that all localities should strengthen the information construction at this level and open and review the review and approval records in a timely manner. Carefully sort out, standardize the registration and filing data of medical devices in this administrative area, and submit relevant data in a timely manner. Failure to report or submit data in a timely manner Poor will be notified and included in the annual assessment.

This year, medical device registration management will continue to strengthen cooperation with associations and associations such as the Chinese Society of Biomedical Engineering, focusing on and researching new technologies and new product areas such as artificial intelligence, precision medicine, and tissue engineering. Organize seminars on medical device innovation. Promoting decision-making and review and approval system reform to provide decision support. Advance custom medical device management research and draft relevant regulations.

Actively promote the work of the chairman of the International Medical Device Regulatory Agency Forum (IMDRF) to promote the coordination, transformation and application of international medical device regulations.

The reporter was informed that in 2018, in the construction of medical device registration management team, it will promote the implementation of government procurement services, further strengthen the construction of the registration management team, improve the treatment of technical reviewers, and enhance scientific supervision capabilities.

The meeting called for medical device registration authorities at all levels to do a good job in improving the Party's work style and clean government, study and implement the spirit of the Nineteenth Party Congress, practice the 'four consciousnesses', implement the 'four most stringent' requirements, and continuously strengthen the registration management team. The construction of ideological style will further strengthen the ideological foundation; strengthen the construction of the medical device registration management system, strictly implement the review and approval and batch operation practices, solidly carry out the prevention of integrity risks, and ensure the safety of the medical device registration management team.