“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 via the policy dated back to April 2018. And then Real-World Data (RWD) of the imported device can be collected to support the regulatory approval from national NMPA.
Over the two years, 100 medical devices and drugs have been imported to Hainan, including four represented by China Med Device, according to press release from Hainan government on June 9, 2020.
We help overseas manufacturers to access the urgent use pathway. We attended the Hainan Real-World Data (RWD) meeting on October 10-11, 2019, joined by National and Hainan Provincial NMPA officials and eight overseas manufacturers, including one represented by China Med Device.
For more information on urgent clinical use in Hainan or RWD in China, please email info@ChinaMedDevice.com.
Five Requirements for Overseas Manufacturers
Hainan government asks foreign manufacturers pay attention to the following aspects:
- 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
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For complete list of the five requirements, please email info@ChinaMedDevice.com.
Five Qualifications of User Facilities
To import the devices, manufacturers need to find qualified user facilities who is to submit the application form to Hainan NMPA. The user facilities need to meet the following criteria:
- Class III hospital with competent department for the intended device
- Has qualified storage facility and management system
- Has adverse event monitoring system with full-time, well-trained staff
- Has ability to implement emergency plans for serious adverse events
- Has manufacturing certifications and passed required assessments
Responsibilities for User Facilities
User facilities take full responsibilities for clinical usage of the imported device. Among them is the establishment and implementation of a record management system:
- Keep certification documents, purchase records, legal bills and acceptance records 3 years after the expiration date
- The retention period should be at least 5 years if no expiration date
- Keep records permanently for implantable devices