Medical Device Registrar System | Let Researchers |

Pharmaceutical Network December 8 Shanghai yesterday, the official implementation of the 'medical device registrant system' for medical device product registration and production license 'unbundled', which means that researchers no longer have to create a production line for how to develop the marketing network And so on and worry, you can 'do my mind research'.

The quality of medical devices can be described as 'human life,' City Food and Drug Administration said the pilot of the pilot in Shanghai 'medical device registrant system' will be strict safety and quality of the bottom line, and timely summary of the system and model innovation practices for the national Explore experience.

Shanghai Opp biological medicine Co., Ltd. General Manager Li Fugang in the field of rapid in vitro diagnosis fought for more than 10 years, the company independent research and development, production of products in major hospital Of intensive care unit, testing department and other clinical front-line applications. Years ago, Li Fu-gang set up a Chong Chuang space for other medical instruments Innovative team industrialization to provide 'come-and-go' service.

A number of innovative projects to be hatched soon gathered, of which the returnees were the majority of the team, but slowly Li Fugang found the people left again, mainly due to the process of making a lot of products to make people go.China's existing Medical devices implement product registration and production licensing "bundled" models. "Bundled" management practices can be very strict with the quality and safety of medical devices because of the high threshold, but to a certain extent, enterprise , Individuals, team innovation and development and continuous improvement product quality For example, it is very difficult for start-ups to build a sophisticated product line or rely on researchers to develop products in the later stages. These are the pain points of innovation.

Learning that the system of medical device registrants will come to an end, Li Fugang is actively applying for the registration of medical device registrars and hopes to become a trustee of more than 200 start-up teams in an incubator.

In the opinion of the industry, there is another significance of the New Deal landing: optimizing the allocation of innovative elements.

Yaojing Er, chairman of Shanghai Transient Life Science and Technology Co., Ltd., was particularly impressed. 'Our main in vitro diagnostic equipment involves genes and biology as well as the introduction of electronics, machinery and talents into the industry as an important factor restricting development. The registration of medical devices When the system of people is on the ground, we need to bring in professionals without any intervention. Instead, we can entrust a professional team. '

The problems encountered by Transfiguration are commonplace, enabling more relevant elements of innovation to be more reasonably configured and requiring top-level design and institutional innovation to help otherwise companies will experience innovative 'ceilings'.

Up to now, there are 26 products in Shanghai entering the special approval procedure of the national innovative medical devices, accounting for nearly 20% of the total number of the country. "To ensure the burst of innovation and vitality, innovation and system protection are even needed," said Xu Lai, deputy director of the Municipal Food and Drug Administration. Shanghai Medical Devices is transforming itself from a low-end manufacturing industry to a high-end design and manufacturing industry to develop and produce a series of high-end medical products such as PET-CT, PET-MRI, proton heavy ion tumor therapy and medical robots.