Meeting Invitation | September 4 — Special Workshop on End-to-End Practical Compliance in Medical Device Clinical Registration (China)

About the workshop: Since 2025, regulatory policy for medical device registration has been upgraded rapidly: the Regulations on the Supervision and Administration of Medical Devices have been revised; the 2025 edition of the Good Manufacturing Practice for Medical Devices adds a standalone chapter on contract manufacturing; and the NMPA has concurrently issued 39 technical guidelines for registration review along with a new edition of the key inspection points for clinical trials. In 2026, the Catalogue of Medical Devices Exempt from Clinical Evaluation (Draft for Comment) and the Guiding Principles for Clinical Evaluation of Artificial Intelligence Medical Devices were released in succession, moving the regulatory framework into a new phase that is more granular, end-to-end, and technology-driven. Against this backdrop, the workshop focuses on hands-on, end-to-end compliance in medical device clinical registration. It is designed to help companies systematically map the compliance requirements of the entire process — from clinical trial design and data management through registration submission to quality system inspection — and to provide an in-depth reading of the latest regulatory changes and review trends. Senior Chinese experts in device registration and clinical affairs have been invited to walk through real projects as case studies, offering ready-to-use compliance toolkits and risk-alert checklists to help companies anticipate review trends accurately and shorten time to market.