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Regulation Track: Sino-foreign Medical Device Policies and Regulations

Co-organizers: Medtec China

Conference Background:

• On March 18, 2021, the State Council issued the newly revised Regulations for the Supervision and Administration of Medical Devices, which created favorable conditions for China’s medical device industry and marked a new stage of legal supervision over medical device in China.
• With the promulgation and implementation of the new version of Regulations for the Supervision and Administration of Medical Devices, supporting rules and documents have been revised and issued, and a new regulatory system for registration management has been built. Regulatory establishment, review and approval of medical device innovation, and premarket and postmarket supervision remain the focus of domestic regulations.
• On European Time July 17, European Union issued the Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices, which specifically describes the relevant matters of MDR/IVDR transitional revision and applies to the references and visits of competent authorities, customs and distributors in non-EU and non-EEA economic zones.
• Devices urgently approved in the COVID-19 period by FDA will gradually transit to routine regulation after May 11, and FDA regulatory policies need to be understood for products exported to the United States.

Who Should Attend?

• Medical Device Manufacturer: Head of Regulatory, Quality, Compliance, Medical, R & D and Project/Enterprise
• Medical Device Regulatory Consulting, Research and Service Companies
• Medical Device Supervision Authorities and Scientific Research Institutions

*Conference agenda updates according to speaker confirming.

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