At the same time, this will further promote the city's medical device Enterprises differentiated division of labor Cooperation, the formation of the regional agglomeration effect, resource optimizati

Pharmaceutical Network July 6, medical device development and production of medical device registration certificate and production license of the ' proof of separation ', since last December in Shanghai FTA Pilot test, now will expand to the city.

Yesterday, the Shanghai Food and Drug Administration issued "on the city's medical device registration system reform pilot extended to the implementation of the citywide bulletin," to allow medical device registration in the whole city of Shanghai medical device manufacturers commissioned by the company to produce products. This measure will further promote the innovation and development of medical devices, rapid huimin, and attract more medical device innovation enterprises to gather in Shanghai, play a resource allocation advantages.

According to reports, the municipal Food and Drug Administration is actively promoting the pilot product category full coverage, but also will promote the new deal to radiation to Jiangsu and Zhejiang, such as the Yangtze River delta area, breaking the regional boundaries, in a wider range of resources to configure innovation. It is reported that the new deal, has made TCL medical and other rapid growth of innovative medical device enterprises have the intention of its research and Development Center as a registered person set up to Shanghai;

At the same time, Johnson, Nathan Force, General Medical Group, bi-di medical devices, such as multinational corporate headquarters are also closely monitoring the progress of the pilot, hope to participate in the pilot to achieve product development and production optimization path.

As the national Medical Device Supervision system review and approval breakthrough, medical device registrant system directly hit the enterprise development for a long time ' pain point '. China's medical equipment has been the implementation of product registration and production License ' bundle ' mode, Medical equipment Research and development institutions must have production equipment, personnel, venues and so on, in order to turn the research and development results into a clinically available product. This greatly affects a lot of Enterprise Innovation and development of research and development institutions and continuous improvement Product quality

Enthusiasm is not in conformity with international rules. Last December, the city Food and Drug Administration issued the "China (Shanghai) Free Trade test area of the medical device registration system pilot Implementation Plan" ("Implementation Plan"), clear product registration and production licensor can be separated.

Plan A, minimally invasive, Yi Si, Kelite, Fosun, such as a group of local enterprises to start immediately explore. At present, there are three enterprises six products in accordance with the "Implementation of the programme" permitted; Three enterprises nine products into the first registration detection channel, of which seven products through registration testing;

57 companies have the intention to participate in the pilot.

However, after more than half a year of pilot, the city's Food and Drug Administration found that the pilot's regional restrictions lead to the advantages of resource allocation is still not obvious enough, so many companies have pilot intention to only through the Shanghai FTA in the form of another company to participate in the pilot. The scope of the expansion of the pilot, local research and development and commissioned the production of Foundry Enterprises is a gospel, the municipal Food and Drug Administration of the Registrar of equipment registrar Lin Feng said that the expansion of the pilot scope will further solve the problem of enterprise participation in the pilot area restrictions, enhance the enthusiasm of enterprises to participate, enrich the pilot