Registrant system reform in Shanghai floor | 26 days to get the medical device license

Yesterday, the Shanghai Food and Drug Administration issued to Shanghai Telecentric Medical Technology Co., Ltd. single channel ECG registration certificate issued by the Medical Equipment Co., Ltd. Shanghai Micro Electro-Physiological Medical Technology Co., Ltd. issued a medical device Production license, which also means that Shanghai launched last year, the medical device registration system innovation and reform officially landed.

In the past, the registration and production of medical devices in our country were bundled together and registration and production must be completed by one main body. This kind of 'bundling' mode affected the innovation and development and continued improvement product quality Enthusiasm, but also limits the rational allocation of innovative elements, and the international prevailing rules and our "Medical Device Supervision Regulations," the legislative spirit does not match.

Telecentric Medical is registered in Shanghai Free Trade Zone R & D companies, holding a single ECG recorder technology, mainly for the acquisition of ECG signals transmitted to the mobile terminal via Bluetooth, with a compact, easy to carry, can A long time to monitor the characteristics of ECG trend, but the company does not have the production capacity before the reform, if you want to obtain the medical device registration card, telecentric medical even if technology, must take the land, set up factories and obtain production licenses This is a huge investment. Even if the factory is built, the main energy in the first year or two will be placed on the application for a production permit. The factory will be idling. If there is no solid financial foundation, it will be hard to come by 'Cloud day' that day.

Understand the difficulties of enterprises, Shanghai Food and Drug Administration immediately carried out research and found that Telecentric Medical is a subsidiary of Shanghai Micro-invasive Group, while the micro-invasive group and other affiliated companies have the relevant medical device production capacity, if also in accordance with the rigid ' Old Road 'is not only a' torment 'for R & D enterprises, but also a waste of resources for ready-made production. Why not let R & D enterprises try new channels of innovation and reform?

Under the guidance of the medical device examination and approval department, Telecentric Medical Co., Ltd. specializes in the application for medical device registration certificate. After becoming the registrant, it entrusts the Shanghai Minimally invasive group to produce samples and finished products within the production-type enterprise, and finally the latter passes the strict evaluation to obtain the production The whole process, the Shanghai Food and Drug Administration uphold 'mandatory standard Do not reduce the legal process does not reduce ', through the inclusion of preferential approval process, simultaneous product registration and production permit system verification and other measures to speed up product time to market, product acceptance from the formal entry into the market only 26 working days, the statutory working time limit Shorten 82%.

'The medical device industry has a very high degree of subdivision. The reform in Shanghai has given R & D and producers' specialization in the field of technology, and has achieved strengths and weaknesses, complement each other and win-win situations. It can be said that the government departments are familiar with the characteristics of advanced industries. The policy is Advance with the times. "Shanghai Micro Electro-Physiotherapy Medical Technology Co., Ltd. Sun Yi-yong, president, said Shanghai launched the medical device registrant system innovation and reform so that single-channel ECG recorder time to market a full year in advance, saving More than 100 million yuan of productive investment.More importantly, domestic and foreign enterprises are researching and developing similar products, the sooner the market is more able to seize market opportunities.Yun Yiyong said the structure of the composition contains' data management software 'and' server front-end software 'ECG recorder, the current approval of Shanghai telehealth only licensed, get permission, all employees are excited.

Xu Lai, deputy director of the Shanghai Food and Drug Administration said that after the rapid development of China's medical device industry, overcapacity has gradually become a significant problem. Shanghai's reform is to 'relax' the system and rationally allocate Shanghai's medical device research and development and production resources. It is forecasted that the reform will consolidate the "platform economy" of Shanghai's medical device industry and be coordinated and strengthened by the specialized enterprises in R & D, production and division of labor. This will help to break through the constraints of land resources and environmental resources and promote the alliance of powerful forces. The gathering of medical device researchers, research and development institutions, innovative enterprises, boosting Shanghai Science and Technology Center construction.

According to reports, the State Food and Drug Administration released January 5 this year, "on the Shanghai food drug Supervisory Authority to carry out medical instruments Registrant System Pilot Project Announcement ", Shanghai Free Trade Zone has more than 20 enterprise Interested in participating in the pilot, including a permit application has been accepted, there are two five products have entered the pre-acceptance inspection phase.