The Hainan provincial government has issued a Notice on the Management Regulations for Clinically Urgently Needed Import Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone. These regulations, set to take effect from May 1, 2023, outline key procedures and responsibilities for the procurement and use of such medical items.
Clarifying Drug and Device Review Time Limits
The provincial Health Commission (HC) is tasked with evaluating the qualifications of medical institutions seeking access to urgently needed drugs and devices. Designated institutions must apply to the HC, which has a 10-working-day window to make a decision. This includes a 5-working-day evaluation period to determine hospital qualifications and a 7-day period for the Medical Product Administration (MPA) to decide on specific drug/device approval.
Special Approved Drugs and Devices Procurement
Designated medical institutions are to entrust licensed drug/device trading enterprises with the procurement, import, and distribution of clinically urgently needed imported drugs and devices. The entrusted enterprise is responsible for the quality and safety of these items and must establish a reporting system for adverse reactions/events. Drugs/devices must be purchased from the marketing authorization holder (MAH)/registrant or an authorized institution, with proof of authenticity required if purchased from other channels.
Medical Institution Requirements
These institutions are required to monitor the overseas status of imported drugs and devices, promptly report any safety risks or significant incidents, and adjust use plans or suspend use/procurement as necessary while informing the Lecheng MPA and adverse drug reaction monitoring department in the pilot area.
Compensation and Commercial Insurance
Designated medical institutions are liable for patient injuries and must compensate first before recovering funds from relevant insurance companies.
Destruction of Licensed Medical Equipment
Expired, damaged, or scrapped clinical urgently needed imported drugs and medical devices must be destroyed under the supervision of the Lecheng medical products bureau, with designated medical institutions required to apply for this process.-Fineline Info & Tech
