January 10, 2020
On December 20, 2019, the NMPA has issued the so-called "Guidelines for Conditional Approval of Medical Devices " (hereafter simply referred to as the “Guideline”). The Guideline was officially implemented on the day of release and will help expedite the conditional approval of medical devices under certain circumstances. Ultimately, this regulation is addressing the need for clinical treatment of severely life-threatening diseases; which require medical devices not yet approved, by speeding up the reviewing process and allowing conditional approval.
The Guideline addresses “the scope”, “the basic principles”, “the requirements of the submission dossiers”, “pre-clinical research requirements”, “pre-market clinical trial requirements”, “conditional requirements”, and the “requirements for post-market surveillance of medical devices with conditional approval for listing”.
In essence, the applicants can collect sufficient pre-market data to verify the efficacy and safety of the medical device. NMPA then reviews and approves the medical device with condition, such as asking for supplementary information. The applicant shall offer the supplementary information by the required date or by the next renewal application of the certificate.
The description of the supplementary information is as stated below:
1. Post-marketing clinical study: The applicant can communicate with CMDE and determine the indicators for the conditional approval of the product. In addition, the requirements of the clinical trial data, standards that can be reasonably evaluated or judged for its clinical benefit, and the design of the clinical trial can be discussed among other aspects.
2. Post-market surveillance: The applicant shall strengthen the surveillance of adverse events of conditional approved medical devices, complying with the relevant provisions of the “Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices”.
The Guidelines for Conditional Approval of Medical Devices for Marketing (2019 No. 93)
China, Conditional Approval, Guidelines