June 12, 2018
During the early week in May, the Hainan Government has issued a further notice for “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. This is applicable to medical devices that are urgently needed for clinical purposes (hereinafter referred to as "emergency devices"). This notice shall take effect on the release date, and will be temporarily implemented for one year.
The key points in the notice are hereby summarized as follows:
1. The partner health institutions shall be Class 3A in China, and the members who use emergency devices must have the appropriate license. Hence, the member shall obtain sufficient training prior to using the device.
2. Lists of submission documents for emergency devices to be used in Hainan Province have been provided. The applicant shall submit relevant documents to the CNDA branch in Hainan.
3. The emergency devices are allowed to be used in partner health institutions only, at the same time, the emergency device shall be used according to its intended use.
4. The medical institutions shall immediately stop using the device which has been recalled overseas, and should take necessary actions to resolve any issues brought about by its use.
5. When the emergency devices are used in a particular medical institution for a considerable period of time and has reached a substantial number of users, the foreign manufacturers shall submit the registration application to CNDA and shall provide them with the relevant reports as well. All manufacturers who fails to submit registration applications for a certain emergency device on a specified deadline shall be given a prior notice to stop its importation and use.