Deputy Director Wang Shucai of the Medical Device Regulatory Department of the National Medical Products Administration Visits Maxin for Research
Editor’s Note:
On May 22, 2019, Wang Shucai, Deputy Director of the Medical Device Supervision Department of the National Medical Products Administration, along with his delegation, visited Fuzhou Maixin Biotech Co., Ltd. for research and inspection. They were accompanied by Zhang Wenchun, Deputy Director of the Fujian Provincial Food and Drug Administration, and Huang Weijun, Director of the Medical Device Supervision Department of the Fujian Provincial Drug Administration. Chen Min, Party Leadership Group Member and Deputy Director of the Fuzhou Municipal Bureau, leaders from the Municipal Bureau’s Medical Device Supervision Department and the High-tech Zone Bureau, as well as Wang Xiaoya, Chairman and General Manager of Maixin Company, and Zheng Yanhua, Manager of the Registration and Quality Control Department, participated in the event.
Figure 1. General Manager Wang introduces the company’s basic situation and product application value to Deputy Director Wang Shucai (third from left) and his delegation at the Maixin Exhibition Hall.
General Manager Wang briefly outlined the company’s development history, explained the importance of immunohistochemistry in current pathological diagnosis, and showcased the company’s research achievements, business performance, and industry development trends in recent years. Subsequently, the registration specialist introduced the company’s basic situation, with a focus on reporting the product lines, R&D platforms, and product registration work.
During the symposium, Deputy Director Wang Shucai and his delegation engaged in in-depth discussions with attendees regarding the impact of category adjustments for in vitro diagnostic reagents, such as immunohistochemistry, on enterprises. General Manager Wang stated that Maixin has always actively supported and complied with relevant national policies and regulations, being the first domestic enterprise to obtain Class III registration certificates for immunohistochemistry (and the most). After the category downgrade, Maixin responded promptly, advancing related product registration work in a timely manner to meet the needs of user units, assist in patient disease diagnosis and treatment decisions, and became the first domestic enterprise to obtain nearly 200 Class I product filing certificates for immunohistochemistry in one go. After listening to the report, Deputy Director Wang Shucai fully affirmed Maixin’s standardized production management and the timely adjustments and efforts made in compliance with national policies and regulations. He expressed understanding of the suggestions raised during the process and hoped that Maixin, as a representative of domestic pathological national enterprises, would maintain confidence and continue to uphold a sense of standardized production management and high responsibility.
Figures 2-3. The research team conducts on-site inspections at Maixin’s comprehensive pathology laboratory and GMP production workshop.
After the meeting, the research team visited Maixin’s comprehensive pathology laboratory and GMP production workshop for on-site inspections. During the interviews, they briefly learned about the technical processes related to immunohistochemistry and the requirements for reagent production and storage management. They highly recognized Maixin’s standardized production and the company’s social value, and expressed that communication and collaboration with regulatory authorities could be strengthened in the future to promote industry self-discipline and healthy development.
Figure 4. Deputy Director Wang Shucai offers suggestions and places high hopes on Maixin.
This research work made Maixin truly feel the close attention and earnest expectations of national regulatory authorities towards local enterprises. Maixin will continue to benchmark against international advanced technological levels, promote innovation, standardization, and service, and hopes to become a representative of sustainable development enterprises in China’s medical device field in the future.