Accurate innovation of Jianwei medical devices

With one belt, one road has been built for more than 10 years, and the support of the state has been successfully developed. On June 5, Tsinghua pacemaker was implanted in Pakistan Recently, at a seminar on medical device innovation and Development held by the State Food and Drug Administration and the China Society of Biomedical Engineering in Beijing, Professor Li Luming of Tsinghua University said excitedly.

From cutting-edge technologies such as neural control technology and clinical rapid detection, to commodity research and development, review and approval, technology transformation, clinical use and other aspects, a number of professionals, scholars and business representatives who have made achievements in the field of medical devices, medical device registration and management department, medical device regulatory department, medical device specification management center, medical device technology evaluation center, and audit and verification The person in charge of the center and relevant personnel have stopped the general and deepening exchanges.

Provide accurate service for innovation

"The combination of government, industry, education, research and medicine, close to clinical needs, and slow down the development and industrialization of new technologies and new products of medical devices are in an excellent era." Hao Hongwei, deputy director of the National Engineering Laboratory of neural regulation technology at Tsinghua University, said.

According to the professionals attending the meeting, the medical device industry has become a rapidly growing category in China's health industry. According to the blue book of China's Ankang industry (2016 Edition), the average annual growth rate of China's medical device industry scale exceeded 20% during the 12th Five Year Plan period. Many documents, such as "made in China 2025" and "Ankang China 2030" planning outline, have understood the obligation to strengthen the innovation of high-end medical devices. The 13th five year plan of national drug safety proposed that the regulation of drug equipment should be improved from time to time, and the reform of drug equipment evaluation and approval system should be deepened; innovation in research and development should be encouraged, the review and approval mechanism should be improved, the requirements for review and approval should be strictly enforced, and the reform of classified management of medical devices should be promoted.

According to the latest statistics from the State Food and drug administration, since the implementation of the "special approval sequence for innovative medical devices" in March 2014, by the end of May of last year, the food and drug administration has received 588 requests for special approval of innovative medical devices, 565 have been reviewed, and 119 commodities have entered the special approval channel for innovative medical devices 26 products such as brain pacemaker, orthopedic surgery navigation positioning fragmentary, percutaneous artificial heart valve intervention, etc. were approved to be put on the market.

In the past years, a series of policies encouraging innovation have been implemented. Among them, the priority approval sequence of medical devices, which came into effect on January 1, sets priority approval channels for medical devices that treat rare diseases, malignant tumors, geriatric diseases, children's public use, clinical urgent needs, and listed in the national science and technology serious special projects or key research and development programs.

At the same time, the State Council issued the resolution of the State Council on Amending the regulations on the supervision and administration of medical devices on May 4, 2014, stopping the supplementary amendment to the regulations on the administration of medical device surveillance, which was implemented since June 1, 2014. Among them, the qualification identification of clinical experimental institutions of medical devices was changed to record management. It is understood that at present, the General Administration of health and family planning is organizing to formulate the filing management methods for clinical experimental institutions of medical devices, and to regulate the conditions and filing order of clinical experimental institutions, which will be issued jointly with the national health and Family Planning Commission.

Not long ago, the State Food and Drug Administration continued to issue four draft proposals on encouraging drug and medical device innovation, slowing down the review and approval of new drug and medical device on the market, proposing that it is necessary to slow down the review and approval of drug and equipment urgently needed in clinical practice, and encourage domestic medical devices to replace export commodities.

Innovation needs accurate development