Hainan NMPA published “Guideline for Importation of Urgently Needed Drugs and Medical Devices in Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone” on October 15, 2021, directing importers and overseas manufacturers on how to get their unapproved but critically needed medical products into Hainan.
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 three years, more than 100 medical devices and drugs have been imported to Hainan, including some represented by China Med Device.
The document has three sections for difference circumstances:
- For drugs that go to Hainan for the first time
- For devices that go to Hainan for the first time
- For drugs and devices that have gone to Hainan before
Application Materials Requirements
- The applicant should be a medical institution that holds a “Medical Institution Practicing License” in Boao zone.
- The medical devices that are urgently needed for clinical import are medical devices that have been approved overseas and have not yet been approved of the same type of products in China.
Application materials include cover letter, qualification documents, ethics review documents and the agreement between institutes and suppliers, clinical usage plan, expert information and Letter of Commitment from medical institutions.
The cover letter shall include the name, specification and model of the device to be imported, country of manufacture, manufacturer (in Chinese and foreign languages), overseas approval status, import quantity, etc.
The qualification documents shall be issued by overseas countries or regions that allow medical devices to be sold on the market and that the medical device manufacturer complies with the medical device quality management system.
Qualification documents shall also contains medical institutions and doctors’ understanding of the medical devices to be imported, including: product working principle, structural composition, passive medical devices need to describe the main raw materials, active medical devices need to describe the main functions and their components (key Functions of components and software); product application scope and applicable population information; overseas approval and listing status and clinical application status; global adverse events overview of planned imported medical devices; clinical research review and ethnic difference use risk assessment; products of the same variety are approved Registration status; the status of domestic substitute products or the quality of medical devices that are significantly better than those of domestic approved medical devices; the qualifications of authorized medical device physicians and instructions for the correct use of medical devices; samples of packaging, labels and instructions and products used in overseas markets Complete real picture.
The ethics review materials include the main scope of application and intended use, instructions for use, review by the medical institution ethics committee, samples of informed consent, etc.
The agreement shall be signed by the medical institution and the supplier shall specify the responsibilities and obligations of both parties.
Approval time limit
7 working days
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