The Provincial Drug Administration came to our company to carry out the activity of "precise docking and precise service"
After the symposium on the development of the medical equipment industry in the province, the food and drug regulatory authority of Zhejiang Province launched the "Precision Matching, Precision Service" activity. On the afternoon of September 19th, Zhen Hui, director of the Medical Device Registration Evaluation Center of the Provincial Food and Drug Administration, visited Xingyue Biotech on site and provided some policy consultation and guidance on project research and development as well as registration evaluation. Xuan Tiefeng, general manager of the company, Ke Changqing, quality director, and various project leaders participated in this matchmaking meeting.
Zhen Hui stated that the provincial food and drug regulatory authority will further deepen the reform of the administrative approval system, vigorously provide technical assistance, intervene in advance and assign dedicated personnel to follow up on innovative and promising medical device varieties, in order to assist enterprises in accelerating the product launch process as much as possible. At the same time, strict control will be maintained over the safety and effectiveness of medical devices, safeguarding the quality and good reputation of medical device products in Zhejiang Province. The main purpose of this matchmaking event is to establish a communication and contact channel between Xingyue and the drug regulatory authority. Secondly, based on existing policies and personal work experience, some policy issues encountered during the company's project research and development process will be addressed on-site.
Comrade Xuan Tiefeng, the General Manager of the company, welcomed and thanked Director Zhen for his visit. He then introduced the progress of the company's existing research and development projects. Subsequently, the heads of each research and development project asked questions one by one regarding the issues existing in various aspects of project development. Director Zhen from the Medical Device Registration Evaluation Center of the Provincial Drug Administration gave patient answers and provided some policy guidance and suggestions regarding product standard formulation, animal experiments, clinical trials, product registration, and the approval of innovative medical devices.
Director Zhen stated that the classification standard for Xingyue Biological's medical device products falls under three categories, with approval authority centralized in the national drug regulatory authority. Regarding the difficult questions that could not be answered at this event, assistance will be provided to establish contact and communication between the enterprise and the national drug regulatory authority. The provincial drug regulatory authority will strive to help enterprises solve problems through diverse service methods and efficient service mechanisms in areas such as regulatory training and green channels, promoting the healthy and rapid development of our province's medical equipment industry.
After participating in the "Precision Matching and Precision Service" event organized by the provincial drug regulatory authority, we have genuinely assisted enterprises in resolving some challenging issues. Furthermore, our company's R&D backbone has gained a deeper understanding of the relevant laws and regulations pertaining to medical device research and product registration.
