The picture shows the 2018 National Medical Device Supervision and Management Work Conference.
In 2018, it was a year of in-depth study of the spirit of the 19th Party Congress and comprehensive deepening of reforms. It was a crucial year for deepening the reform of the medical device review and approval system and fully implementing the "13th Five-Year National Drug Safety Plan." The reporter learned from the National Medical Device Supervision and Management Work Conference held in Shanghai on March 19 that in 2018, a series of medical device registration management tasks will be substantively focused on the goal of ensuring the use of high-quality and high-performance medical devices by the people. Sexual advancement.
It is reported that the general idea of ​​the registration management of medical devices in 2018 is: to thoroughly study and implement the spirit of the 19th National Congress of the Communist Party of China, and to guide the implementation of the national food and drug supervision and management and the work of party style and clean government with the guidance of Xi Jinping's new era of socialism with Chinese characteristics. The work deployment, conscientiously implement the "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as "the Regulations"), the "13th Five-Year National Drug Safety Plan", "Opinions on Reforming the Examination and Approval System for Drug Medical Devices," and "Deepening the Review" Comment on the reform of the examination and approval system to encourage the innovation of pharmaceutical medical devices (hereinafter referred to as "innovation opinions"), strengthen the construction of laws and regulations and the capacity of registration management, deepen the reform of the examination and approval system, encourage the innovation and research and development of medical devices, and continuously improve medical devices. Registration management level of work.
The regulatory system will be further strengthened
The meeting clarified that in 2018, the medical device registration management work will thoroughly implement the "Innovation Opinions", do a good job in the revision of the "Regulations", and focus on implementing the system of medical device listing permit holders. It is necessary to insist that the enterprise is the subject of quality and safety responsibility, and clarify the legal responsibility of the holder for the whole process and the whole life cycle of product design and development and clinical trial. In-depth study and gradually implement the national unified review, clinical evaluation of medical devices and other content. After the official amendment of the "Regulations", the relevant regulations such as the "Administrative Measures for the Registration of Medical Devices" shall be promptly revised. Any amendments and inconsistencies with the amendments to the Regulations shall be revised or abolished. Formulate guidelines for the revision and management of medical device technical review guidelines, and organize and revise 40 guidelines for technical review of medical device registration. Continue to organize training on medical device registration regulations.
The meeting requested that all localities should actively support and participate in the relevant laws and regulations, strengthen the publicity of medical device registration management regulations and rules, and supervise and inspect the implementation of laws and regulations.
The reform of the review and approval system will be further promoted
The reporter was informed at the meeting that this year, the reform of the medical device review and approval system is to establish a more scientific review and approval system, encourage research and development innovation, meet the urgent needs of the clinic, improve the clinical evaluation requirements, and strengthen the on-site inspection will introduce more powerful measures.
Strengthening the evaluation of quality management system and optimizing the approval process meeting. In 2018, the quality management system for medical device evaluation will be fully implemented. The quality management system for medical device evaluation will be established and extended to all provincial evaluation agencies to explore the establishment of the country. Medical device review quality management system. To achieve the unification of the second-class medical device product evaluation standards and norms, and use the file review, internal review, user feedback and management review mechanisms to conduct regular performance evaluation of the quality and efficiency of the review.
Encourage R&D and innovation to meet clinical urgent needs This year, we will revise and issue the “Special Approval Process for Medical Device Innovationâ€, and revise and improve the “Regulations for the Examination of Approved Applications for Special Approvals for Innovative Medical Devices†and “Guidelines for the Examination and Approval of Approved Medical Device Approvals (Trial)â€. Under the premise that the standard is not reduced and the procedures are not reduced, special review and approval of innovative medical devices shall be implemented; priority approval projects shall be given priority in the process of technical review and administrative examination and approval. Improve the review and approval system for clinically needed special medical devices, study and formulate the review operation specifications and registration technical review guidelines for the conditional approval of clinically needed medical devices, refine and improve the application requirements, and establish priority channels for review and approval.
Improve clinical evaluation requirements, strengthen on-site inspections This year will revise the "Guidelines for Clinical Evaluation of Medical Devices", study and draft the "Regulations on the Development of Medical Device Explosive Clinical Trials", and promote the promotion of "Measures for the Management of Clinical Device Clinical Laboratory Conditions and Filing Management" Implementation and training, guiding medical institutions and relevant units to use the medical device clinical trial institution record management information system for filing as soon as possible. Organize the training of "Quality Management Standards for Clinical Instruments Clinical Trials" (hereinafter referred to as "Medical Device GCP") and establish a team of GCP inspectors for medical devices. Increase the supervision and inspection of clinical trial institutions and clinical trial projects. To study and establish a registration system verification guide, organize supervision and inspection of registration application items, supervise and check the authenticity of test samples and clinical test samples, and the consistency of registration application materials with actual R&D production.
The meeting requested that all localities should actively promote the reform of the medical device review and approval system, continuously strengthen the capacity of review and examination and approval, complete on-site verification of the registration system in strict accordance with the time limit, and strengthen the supervision of clinical trial institutions and pilot projects. For the act of falsifying and falsifying, insist on punishing people and severely punishing illegal and criminal acts.
Standard supervision and implementation is the most important
The reporter learned that this year will continue to promote the basic management of registration, management, such as medical device standards, classification, naming, and coding. The first is to strengthen the management of standard projects and revisions. Improve the proportion of major basic standards, high-risk product standards, and strategic emerging industry standards, and improve the proportion of common basic standards, method standards, and management standards. Organize and carry out 100 standard revision and revision tasks, carry out industry standard evaluation work, and improve the optimization standard system. The second is to continue to promote the classification management reform. Organize and guide the training of the "Medical Devices Classification Catalogue" (hereinafter referred to as "Catalogue"), do a good job in the implementation of the "Catalogue", and strengthen supervision and inspection. For the past non-standardized approval products, the corresponding treatment measures shall be formulated according to the categories to be corrected and standardized. The third is to substantially advance the coding of medical devices. The organization develops a unique identification system rule and related standards, and gradually establishes a medical device identification database. The fourth is to strengthen the naming management. Organize the development of some medical device naming terminology guides such as implanted devices, and study and develop the naming terminology guide implementation policy.
The implementation of medical device standards supervision is a top priority. The meeting emphasized that all localities should strengthen the publicity training, supervision and inspection of medical device standards, classification, coding and naming work in their respective administrative regions. In the review and approval work, it is necessary to strengthen the implementation of mandatory standards, scientifically and reasonably, prudently grasp the applicability of the handling of recommended standards and registration technical review guidelines, strictly implement medical device classification rules and naming rules, and implement the "Catalogue" jobs.
“Smart Regulation†will continue to innovate
The topic of "smart regulation" was widely discussed at the meeting. The reporter learned that the regulatory authorities will study and establish a unified online application platform for medical device acceptance review and approval, realize the electronic submission and review and approval of registration applications; initiate the construction of the listed variety archives, and build a product registration declaration information file based on the implementation of electronic declaration. And product registration approval information files; actively do innovation, prioritize product review conclusions and disclose all information; strengthen registered product database management, standardize data formats, and uniformly report registration data to data sharing platform to achieve data interconnection To improve data utilization.
The meeting requested that all localities should strengthen the informatization construction of this level and promptly publicize the review and approval and filing information. Carefully sort out and standardize the registration and filing data of medical devices in the administrative area, and submit relevant data in a timely manner. If the report is not submitted in time or the data is submitted poorly, it will be notified and included in the annual assessment.
Strengthen research and international exchanges
This year, the registration of medical devices will continue to strengthen cooperation with associations and societies such as the China Biomedical Engineering Society, focusing on and researching new technologies and new products such as artificial intelligence, precision medicine , and tissue engineering. Organize medical device innovation seminars to provide decision support for promoting the reform of the review and approval system. Advance research on customized medical device management and draft relevant management regulations.
Actively do the work of the rotating chairman of the International Medical Device Regulatory Agency Forum (IMDRF) to promote the coordination, transformation and application of international medical device regulations.
Strengthen the construction of the registration management team
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 the ability of scientific supervision.
The meeting called for the registration and management departments of medical devices at all levels to earnestly do a good job in building a clean and honest government, thoroughly study and implement the spirit of the 19th Party Congress, practice the "four awarenesses", implement the "four most stringent" requirements, and continuously strengthen the registration management team. The construction of ideological style will further build the foundation of the mind; effectively strengthen the construction of the medical device registration management system, strictly implement the operational standards for review and approval, and conduct solid security risk prevention work to ensure the safety of the medical device registration management team. (China Medical News)
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