Hainan Boao special zone allows overseas unapproved medical devices, IVDs, drugs in China to be used. In addition to the overseas medical products being sold and commercialized faster through this special program, overseas manufacturers can apply for RWS to collect RWD as China local clinical evidence to support its National registration approval.
Since China does not have a formal pre-sub channel like the US FDA, this guideline established a more formal communication process and roles and responsibilities between local provincial and national NMPA offices with the overseas manufacturers. We have participated in this program since it was first launched in 2019 in Hainan Boao.
CMDE (Center for Medical Device Evaluation) and Hainan provincial NMPA released the “Medical Device Real-world Data Application Communication Procedures” on April 18, 2022, to help manufacturers understand the NMPA-initiated program covering RWD clinical evaluation and registration.
The NMPA granted approvals to Boston Scientific’s Rezūm Water Vapor Therapy equipment, and its disposable prostate treatment accessory in March 2022. It only took four months for the two devices from submitting the registration application to guaranteeing approval.
Allergan’s glaucoma drainage system, and J&J’s femtosecond laser eye treatment system utilized the same pathway to get national approvals in 2021.
Responsibilities of parties
National NMPA CMDE
Establish a working group led by the Department of Clinical and Biostatistics which is responsible for answering more complex questions, providing comments in the first and last meetings and reviewing the communication records,
Provincial Hainan NMPA
Responsible for collecting and sorting questions raised by registration applicant, organizing communication meetings, answering simple questions, etc.
Registration applicant
Responsible for conducting real-world research, preparing application materials, and sorting out questions that need to be answered by the CMDE or Hainan NMPA.
Workflow
- Hainan NMPA organizes first meeting
Hainan NMPA, CMDE and registrant applicant participate in the meeting. The applicant introduces the scope of application, structural composition, working principle, mechanism of action, preclinical research, existing clinical evidence, and development of real-world research.
- Applicant specifies follow-up questions and submits application for communication
Before submitting an application for product registration, the applicant may submit a communication request to Hainan NMPA and provide supporting materials to the questions.
- Preliminary examination and reply by Hainan NMPA
- Applicant submits complex issues to CMDE
- CMDE replies
- Hainan NMPA organizes final meeting
The document gives detailed explanation for the workflow. For an English copy of the Communication Procedure, please email info@ChinaMedDevice.com.
Takeaways for Manufacturers
- After the clinical urgency status is granted, Hainan NMPA will organize the first meeting within 10 working days.
- The registration applicant shall make sure that the questions are explained clearly, and the supporting materials are sufficient.
- Issues already resolved should not be submitted again.
- Hainan NMPA will submit the communication records to CMDE on 25th of each month.
- The audited communication records may be used as the basis for Hainan NMPA to answer similar questions for other applicants.