Communications concerning Medical Device Clinical Real-World Data Applications have been clarified through the recent issuing of the Hainan Communication (SOP) Standard Operating Procedure for Medical Device Clinical Real-World Data Applications (Trial) (No.16-2022).
The Hainan Communication SOP lays out the communication procedures for real-world data clinical trial applicants to help them better prepare their application dossier for NMPA (National Medical Products Administration) registration.
The Hainan Communication SOP Working Procedures are as follows:
- The Hainan MPA arranges the first meeting where the applicant should present:
- the scope of application
- structural composition
- working principle
- action mechanism
- preclinical research
- existing clinical evidence
- real-world studies
- registration declaration.
- The Hainan MPA internal team will collect and answer simple questions asked by the applicants whilst the working group under the Center for Medical Device Evaluation (CMDE) will respond to complicated questions, review communication records, etc.
- After the first meeting, the applicant can submit an application for communication and information exchange to the Hainan MPA with questions related to the real-world studies or the registration dossier before the actual product registration application.
- The Hainan MPA will conduct a preliminary examination of the questions submitted by the applicants to ensure the questions are clear, sufficiently supported, and within the scope of application, otherwise, the applicant will be notified.
- The Hainan MPA will compile a list of questions such as product design verification and confirmation, clinical evaluation, etc. and submit them to the CMDE before the 25th of each month.
- The CMDE may still ask the applicants (via the Hainan MPA) to provide supplementary information if their questions are out of scope, unclear, or without sufficient supporting information. Otherwise, the CMDE should provide feedback to the Hainan MPA before the 25th of the following month, and the Hainan MPA should promptly forward the respond to the applicants.
- If required, the Hainan MPA may arrange a final meeting with the applicants to present:
- the basic product information
- preclinical research
- clinical evaluation
- real-world research
- other registration declaration materials and review all of the questions that have been asked by the applicants
The applicant should collect the opinions and suggestions from the CMDE and Hainan MPA in the final meeting to prepare the final registration dossier for submission.
Real-word clinical data collected in Hainan can be used as supplementary evidence for a full NMPA registration that would enable China-wide sales. Medical devices and IVDs that have not yet registered with the NMPA can be imported into the Boao Lecheng International Medical Tourism Pilot Zone in Hainan province with the approval of the Hainan provincial MPA (Medical Products Administration).
Once a product is approved for use within the Boao Lecheng Pilot Zone, the product can, with the consent of the Hainan MPA and the NMPA, collect real-world data on Chinese nationals.
By Julie Zhang and Jacky Li. If you would like to learn more about supervision of medical device business operations in China or our registration and CRO services for medical devices, IVDs, pharmaceuticals, cosmetics or other products, please contact Cisema.