CFDA Medical Device Conference reveals six major directions for supervision

In April 2018, the medical network was deeply involved in the Party's Nineteenth Congress and a year of comprehensive deepening reforms. It was an in-depth reform of the examination, approval and approval system for medical devices, and the full implementation of the “13th Five-Year” National Drug Safety Plan. The key year of the year.

The reporter learned from the National Medical Device Supervision and Management Conference held in Shanghai on March 19 that in 2018, with the goal of ensuring that the masses use high-quality, high-performance medical devices, a series of medical device registration management tasks will be given Sexual advancement.

It is reported that the overall thinking of the medical device registration management work in 2018 is: In-depth study and implementation of the spirit of the Nineteenth National Congress of the Communist Party of China. Guided by the socialist ideology with Chinese characteristics in a new era, the food industry will implement the food all over the country. 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 "Thirteenth Five-Year National Drug Safety Plan", "Opinions on Reforming the Evaluation System for Drugs and Medical Devices," and "Innovation on the Deepening of the Review, Evaluation, and Approval System to Encourage the Innovation of Pharmaceutical 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 the innovation and research and development 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 implement the "Innovation Opinion" in-depth, do a good job in the revision of the "Regulations", and focus on the implementation of the holders of medical device marketing license.

To adhere enterprise It is the consciousness of the responsible subject of quality and safety, and it clearly defines the legal responsibility of the holder for the whole process of product design and development and clinical trials and the whole life cycle.

In-depth study to gradually implement the national unified review, clinical evaluation of medical devices and other content.

After the official amendment of the “Regulations” is published, it must pay close attention to the revision of the “Measures for the Registration of Medical Device Registration” and other supporting regulations. If it is inconsistent with the amendments to the “Regulations,” it shall be amended or repealed.

Formulate management regulations for the revision and implementation of guidelines for the technical review of medical devices, and organize the development of 40 guidelines for technical review of medical device registration. Continue to organize the registration of medical devices. 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 review and approval system for medical device review will establish a more scientific review, 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 Devices Review Quality Management System.

Achieve review of second-type 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 Examination and Approval Procedure for Medical Device Innovation” will be revised and revised, and the “Certificate for the Examination of Innovative Medical Device Special Approval Application” “Approval Code for the Examination and Approval of Medical Device Priority Approval (Trial)” will be revised and improved.

Under the premise of no reduction in standards and no reduction in procedures, special review and approval of innovative medical devices will be implemented; priority inspection projects will be given priority in the process of technical review and administrative approval.

We will improve the system for review, approval, and approval of clinical medical equipment urgently needed for special medical devices, study and formulate guidelines for the review and operation of clinically urgently needed medical devices conditionally approved for listing, and guidelines for registered technical review. We will refine the requirements for filing information and establish 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 on the Administration of Medical Device Expandable Clinical Trials", and promote the promotion of the "Measures for the Management and Registration of Medical Device Clinical Trial Institutions" Implementation and training, guiding medical institutions and related units to use the medical device clinical trial institution filing management information system for filing as soon as possible.

Organize and carry out the "Medical Device Clinical Trial Quality Management Specification" (hereinafter referred to as "Medical Device GCP") training, and establish a medical device GCP inspector team. Strengthen the supervision and inspection of clinical trial institutions and clinical trial projects. Study and formulate guidelines for registration system verification. Organize the supervision and inspection of registered applications, supervise and inspect the authenticity of the test samples and clinical test samples, and the consistency of the registered filing data with the actual R&D production.

The meeting demanded that all localities actively promote the reform of the examination, approval and approval system for medical devices, continuously strengthen the review and approval of the 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.

This reporter learned that this year will continue to promote basic standards of registration, management, classification, naming, and coding of medical devices.

The first is to strengthen the management of standard projects and the work of system revision. The priority standards for major basic standards, high-risk product standards, and strategic emerging industries are to be established, and the ratio of revisions to general basic standards, method standards, and management standards should be improved. About the standard system revision task, carry out the industry standard evaluation work, perfect the optimization standard system.

The second is to 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. According to the previous non-standard examination and approval of products, organize and formulate corresponding Measures to correct and regulate.

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 the naming management. Organize the development of implanted devices and other parts of medical device naming guidelines, and study Formulate guidelines for the implementation of naming guidelines.

The implementation of medical device standards supervision is the most important task. The conference emphasized that all localities should strengthen publicity training and supervision and inspection 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, strictly implement the classification rules and naming rules for medical devices, and do a good job of implementing 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 review conclusions of products and disclose all information based on priority; Strengthen management of registered product database, standardize data format, The 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. Conscientiously sort out, standardize the registration of medical devices in this administrative area and record data, and timely submit relevant data. 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.