Hainan government issued the “Administrative Measures of Clinically Urgent Imported Drugs and Medical Devices Taken Out of the Hospital in Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone” on October 12, 2023. It says that the oral, topical, and subcutaneous injections of drugs and devices can be taken out when patients leave the hospital.
How it Works
Below are the highlights of the document:
- Topical products are suitable for use in the eyes, nose, ears, skin, etc. Subcutaneous injection ones are suitable for situations where medical institutions have fully evaluated and determined that the risk of use is controllable, used for the treatment of chronic diseases, and can be completed by oneself.
- The amount of medicine taken out of the hospital should refer to the prescription regulations of medical institution. According to the patient’s diagnosis and treatment needs, the time of leaving should in principle not exceed 4 weeks; for chronic disease patients with stable conditions and mild adverse drug reactions, the time can be extended, but should be limited to 12 weeks.
- For long-term prescriptions lasting more than 4 weeks, doctors should strictly evaluate them, strengthen patient training, record in medical records, and confirm with the patient’s signature.
- Medical institutions submit filing materials to Lecheng Medical Products Administration through the licensed drug and device traceability management platform. If the information is complete, the medical institution will enter the key information, generate a unique registration number, and complete the registration.
- When patients leave the hospital, the medical institution associates the patient with the drug information on the licensed drug and device traceability management platform and determines that the smallest independent package of the drug or device is affixed with a traceability code, enabling full traceability.
Hainan RWD Pilot Program
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. While commercializing and selling their products, manufacturers can collect RWD through RWS in Hainan as local clinical evidence in China to support their national NMPA registration approval. The special program might fasten their China market access to 4 months.
Hainan government released the “Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port” on March 28, 2023. The document says that It does NOT require local type testing or significant burden of proof as the national approval.
For the “Guideline on Medical Device Real World Study Design Statistical Analysis (Draft)”, please click HERE
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