On December 21, the summary and evaluation meeting of the two-year anniversary summary and evaluation meeting of the biomedical industry and the biomedical product registration guidance workstation was held in the conference center of Da Zero Bay Science and Technology Innovation Building. The highlight projects of a number of district-level workstations such as the Minhang District Biomedical Registration and Guidance Service Workstation (hereinafter referred to as the "Minhang Workstation") were displayed on the spot.
Up to now, under the guidance and support of Minhang workstationareaThree products from three companies, Shanghai Aikante, Shanghai Lixiao Medical Technology and Shanghai Tengfu Medical Technology, have been approved to enter the special review channel for innovationTwo products of two companies including Shanghai Sidi Biotechnology have entered the national priority approval channel;Four companies are docking service innovative products and are expected to apply for national innovative medical devices.
Thanks to the enthusiastic guidance of the workstation staff, the registration time that should have been about one and a half years has been shortened to 10 monthsAnd assisted us to obtain the production license in 1 week, which greatly accelerated the production and market process. Yuan Lingzhi, registration director of Shanghai Aikante Medical Technology Co., Ltd., hereinafter referred to as "Shanghai Aikante"), which is located in Caohejing Shuangchuang Park, Pujiang Town, told reporters.
It turned out that during the visit last year, the personnel of Minhang workstation found that the "daily wear rigid scleral contact lens" product of Shanghai Aikante was the first in China, which had the prerequisites for applying for innovative medical devices, and took the initiative to "check the pulse" and send a good prescription to the enterprise.
Bai Le, the director of Minhang workstation, said, "Since October last year, when the company began to register and declare, we have actively recommended the company to the Municipal Bureau, and received a positive response from the Municipal Food and Drug Administration and the Municipal Device Review CenterExperts have been sent to work with the workstation personnel for many times to provide professional guidance on the innovation declaration process and quality systemBy August this year, the product obtained the registration certificate of Class III medical devices, the registration time was greatly shortened, and the product was successfully sent to the 'fast lane' of listing. ”
In addition to the "speed-up" of innovation declaration, Minhang workstation also further extends its service tentacles, so that enterprises can avoid detours.
At the end of October, Shanghai Aikante encountered a bottleneck in the procurement of production equipment, "We were originally cooperating with a foreign equipment manufacturing company, which was facing problems such as high equipment cost and long procurement cycle," Yuan Lingzhi saidAfter knowing the situation, the workstation staff quickly helped to 'match' a local precision instrument company in the region for production equipment research and development in accordance with our demandsIf domestic substitution can be realized, it will greatly reduce production costs, and now the equipment is in the commissioning stage and is expected to be launched next year. ”
There are not a few cases of enterprises like this, and the Minhang workstation has sorted out and classified the demands and problems raised by enterprises in the area through research and visits, and fed back to the District Market Supervision Bureau, the District Science and Technology Commission and other relevant departments for docking, so as to solve the demands of enterprises in a timely manner.
Based on Shanghai Jiao Tong University and East China Normal University, Minhang Workstation is promoting the transformation and implementation of original and leading scientific and technological research achievements in the school," said Baile"From mining our own scientific and technological innovation resources, looking for suitable cooperative enterprises, to counseling innovation declaration, product registration, patent application, etcWe have carried out escort services for start-up enterprises, and have formed a model of 'school-enterprise co-construction + industry guidance + investment incubation + resource sharing', which has played a positive role in the development of biomedicine. ”
In the first half of 2023 alone, Minhang Workstation has contacted nearly 300 enterprises in the district, and conducted on-site visits to nearly 50 enterprises to understand the specific situation of enterprises.
Behind the "two-way rush" between biomedical enterprises and functional departments, it is natural that the "escort" of relevant units such as the District Market Supervision Bureau is indispensable. Zhou Lei, chief of the medical device section of the District Market Supervision Bureau, saidIn accordance with the principle of "early intervention, cross-front service, and joint guidance", the District Market Supervision Bureau has built a comprehensive and full-chain service guidance platform for medical device drug research and development, registration and productionIn the early stage of the research and visit, a database of key cultivated enterprises was established. Next, the District Market Supervision Bureau will take the database enterprises as the key cultivation objects for guidance services to stimulate the innovation vitality of enterprises.
Reporter: Wu Junyan.
Contributed by: District Market Supervision Bureau.
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