Clinical Urgent Need Equipment | 'Conditional Approval' | Gradual Approach

On April 26th and April 23rd, the medical network quickly sent positive feedback on the mobile phones of medical device companies, health care institutions, and scientific research institutes to the “Medical Urgent Need Medical Device Information Collection Form.” This was the day. A new initiative launched by the Center for Medical Device Evaluation (hereinafter referred to as the Censorship Center) is a clinically urgently needed medical device for the treatment of severely life-threatening and ineffective treatment options (hereinafter referred to as 'clinically urgently needed medical devices'). ) The relevant information. This release has a positive signal - the examination center intends to develop clinical review of the urgently needed medical devices conditional listing of relevant regulatory practices and guidelines.

In recent years, China’s medical device industry has developed rapidly and the innovation support system needs to be “strengthened”. In October 2017, the China Affairs Office and the State Council issued the “Encouragement on Deepening the System of Review, Approval and Approval. drug medical instruments The "Innovative Opinions" (hereinafter referred to as "Opinions") proposes 36 specific measures for the deepening of the review, approval and approval system, and encourages the innovation of pharmaceutical machinery. The purpose is to promote the adjustment of China's pharmaceutical machinery industry structure and technological innovation, enhance industrial competitiveness, and meet the public's clinical needs. Among them, the “accelerated clinical trials for accelerating the urgent need for medical devices for medical devices” was clearly proposed. 'For urgently needed pharmaceutical medical devices, early clinical trials, mid-term indicators showing efficacy and predictable clinical value, can be approved conditions listed enterprise A risk management plan should be developed and research carried out as required'.

Since the publication of the Opinions, the national food and drug regulatory authorities have fully implemented the pilots of the licensing system for medical device holders, changed the management methods of clinical trial institutions, and improved the mechanism for reviewing innovative medical device examinations. The State Food and Drug Regulatory Authority in 2017 Approval of branched aortic stent graft and delivery system, intervention in artificial organisms heart 12 domestic initiatives, including the world's leading innovative products, are listed on the market. In addition, the Center also signed strategic cooperation agreements with the Food and Drug Administration of Zhejiang, Guangdong, Jiangsu, and Shanghai to establish innovative service stations and strengthen innovation. The guidance for medical device declarations encourages the innovation of medical devices. These measures have effectively promoted the process of registration and listing of clinically urgently needed medical devices and further fulfilled the needs of the public.

According to the deployment of the National Conference on Medical Device Supervision in March this year, the national drug regulatory authorities will further improve the system for the review, approval and appraisal of clinically urgently needed medical devices. This involves the study and formulation of conditional approvals for the listing of clinically urgently needed medical devices. Registration of technical review guidelines, detailed refinement of filing requirements, establishment of a priority channel for review, and accelerating the advancement of urgently needed medical devices for clinical approval.

It is worth noting that the relevant person in charge of the equipment examination center told the reporter that according to the spirit of the "Opinions", the examination and examination center of the device is working out the criteria and guidelines for the review of conditional listing of clinically urgently needed medical devices. They will solicit opinions from the public in the near future. 'Currently, the work related to the establishment of the "Approval Procedures for the Examination and Assessment of Clinical Urgent Needs for Medical Devices" has also been started. To better accomplish this work, we seek information on clinically urgently needed medical devices for the entire society. We hope that scientific research related to such products will be conducted. Units, manufacturing companies, clinical staff, and related professionals are actively involved in providing information related to such products or clinical use. 'The responsible person said.