日期 : 2021-04-28
The State Food and Drug Administration attaches great importance to the innovation and development of medical devices, and while resolutely maintaining the bottom line of the safety of the public's use of equipment, it promotes the innovative development of the industry.
The first is to formulate and implement special review procedures for innovative medical devices. At present, more than 100 products with strong innovation, high technical content and significant clinical value have been put on the market. The main products are implant intervention equipment, high-end imaging equipment, in vitro diagnostic equipment and reagents, and high-end medical equipment such as artificial intelligence medical equipment, representing the highest level of medical equipment innovation in my country.
The second is to optimize the review and approval process, and scientifically set review requirements. Change the clinical trial institution from an approval system to a filing system, and clarify the "implicit" licensing system for clinical trial approval. Scientifically adjust the "Catalogue of Class III Medical Devices Subject to Clinical Trial Approval". Publish multiple batches of catalogs of medical devices exempted from clinical trials. The "Guidelines for the Design of Clinical Trials of Medical Devices" and other documents were issued, and the requirements for clinical evaluation of medical devices were continuously improved. Issued the "Regulations on the Management of Expanded Clinical Trials of Medical Devices (Trial)", "Guiding Principles for Conditional Approval of Medical Devices on the Market", etc. to further meet the urgent needs of clinical patients. The electronic application of medical device registration was launched, and the whole process of acceptance, review, and certification was realized electronically.
The third is to promote the pilot program of the medical device registrant system to stimulate the endogenous driving force of industrial innovation and development. As of November 2020, a total of 552 products have been approved for listing in accordance with the pilot medical device registrant system. Issue the "Announcement on Matters Concerning the Production of Imported Medical Device Products in China's Domestic Enterprises" to simplify the requirements for the domestic production of imported medical devices.
The fourth is to do a good job in building the basic system of registration management. The "Notice on Further Strengthening the Management of Mandatory Industry Standards" was issued to standardize the management of mandatory industry standards. Establish a database for a unique identification system for medical devices, and promote the pilot and implementation of unique identification for medical devices. Accelerate the research on scientific research projects of medical device supervision and obtain preliminary results. Continue to improve the level of international cooperation, actively undertake international projects, and actively transform the outcome documents of international organizations.