"Regulations on the Management of Imported Medical Devices Urgently Needed in the Hainan Pioneer Zone" was published by Hainan government on June 2, 2020. This important document mandates the qualification of user facilities (hospitals) and the process of application evaluation, and clarifies the requirements for user facilities, overseas manufacturers, distributors, and bonded warehouses.
The foreign-approved devices for urgent Chinese clinical needs, without predicates approved in China, can be imported to Hainan. And then Real-World Data (RWD) of the imported device can be collected to support the regulatory approval from national NMPA.
Hainan government asks foreign manufacturers pay attention to the new requirements, including:
- Provide training to ensure user facilities' correct use of medical devices
- If the product causes harm to patients, the user facilities can seek compensation from the overseas manufacturers based on regulations or contracts
- If a certain number of uses and effects have been achieved, the Hainan NMPA will inform the overseas manufacturers to apply for national NMPA approval. If the application for registration is not submitted on time, the importation and usage of the device shall be stopped
What's your opinion on this new regulation? We'd like to know your cases or experience about handling RWD in China, US or EU.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------