“Medical Device Registrant Regulations Interpretation” Special Training: Sichuan Innovation Technology Co., Ltd. Invited as Speaker
As China deepens reforms in medical device review and approval systems, the registrant system has been fully implemented to support the separation of R&D and production in medical enterprises. Relevant authorities are taking measures to help stakeholders understand regulations, enhance compliance capabilities, and promote high-quality development in the medical industry.
On April 9, 2025, Sichuan Innovation Technology Co., Ltd., in collaboration with Chengdu Economic and Technological Development Zone Science & Technology Industrial Incubation Park and the Sichuan Province Pharmaceutical R&D Technology Innovation Resource Sharing Service Platform, hosted a special event on interpreting the medical device registrant regulations. The event attracted numerous leaders and personnel from medical enterprises in Longquanyi District.
The event specially invited Yang Ansoon, National Registered Auditor, Special Lecturer of the National Medical Products Administration, and General Manager of Sichuan Innovation Technology Co., Ltd., as the keynote speaker. With extensive theoretical knowledge and practical experience in medical devices, he provided an in-depth interpretation of the medical device registrant regulations, detailing the opportunities and challenges they present to enterprises within the current economic context.
Yang Ansoon emphasized that the implementation of the registrant system clarifies that registrants are legally responsible for the full lifecycle management of medical device development, production, operation, and use. In the current economic environment, the system offers enterprises opportunities to optimize resource allocation and reduce operating costs. Companies can focus limited capital and effort on product R&D and innovation through outsourcing production, enhancing core competitiveness. Furthermore, the registrant regulations provide clearer pathways for domestic production of imported devices and the industrialization of research outcomes.
He further highlighted that as a high-demand industry, medical devices still have broad market potential. Companies should leverage the policy benefits brought by the registrant regulations, strengthen cooperation with professional institutions, and accelerate product market entry. Sichuan Innovation Technology Co., Ltd. is an independent third-party CDMO innovation platform specializing in medical device R&D, production, and services. As the first medical device CDMO platform in western China compliant with both U.S. FDA and China GMP standards, it provides tailored services for enterprises in Longquanyi District from concept to compliant industrialization and market launch.
The lecture received unanimous praise from participating enterprises, with attendees expressing that they benefited greatly. One representative commented: “Mr. Yang’s explanation was clear and insightful, giving us a better understanding of the medical device registrant regulations and new directions for enterprise development.”
This lecture not only provided valuable guidance to medical enterprises in the Economic & Technological Development Zone incubation park but also injected new momentum into the high-quality development of Chengdu’s medical device industry.
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