Interpretation of the “Special Review Procedure for Innovative Medical Devices”
Release time:
2025-03-01
One of the review criteria for innovative medical devices is that the applicant must legally hold an invention patent in China for the product’s core technology. Given that there are instances in which applications for core-technology invention patents have been published by the patent administrative department under the State Council but ultimately not granted, a preliminary evaluation of the product’s core technical solution has been added.
I. Requirements Related to Patents in the Special Review Procedure for Innovative Medical Devices
One of the review criteria for innovative medical devices is that the applicant must legally hold an invention patent in China for the product’s core technology. Given that there are instances where applications for core-technology invention patents have been published by the patent administrative department under the State Council but ultimately have not been granted, a preliminary evaluation of the product’s core technical solution has been added.
The Patent Search and Consultation Center of the National Intellectual Property Administration is a directly affiliated institution of the National Intellectual Property Administration, and applicants may submit search requests to the Center.
To further encourage innovation and stimulate the R&D vitality of medical device manufacturers, and taking into account the characteristics of patents and the average R&D cycle for medical devices, the time limit for submitting an application for special review of innovative medical devices is set at no more than five years from the date of publication of the patent grant.
II. On the Methods and Content for Communicating Review Results for Innovative Medical Devices
Applicants may log in to the Review Progress Inquiry Page on the website of the National Medical Products Administration’s Center for Medical Device Evaluation to check the review results. The information provided shall include the review conclusion, the date of case closure, the reasons for disapproval (for disapproved items), and the regulatory classification (for approved items), among others. Following the implementation of the newly revised procedures, paper notification letters will no longer be mailed.
III. Approaches to Communication and Exchange with Innovative Medical Device Enterprises
In accordance with the principles of early engagement, dedicated case management, and scientific review, and in line with the requirements set forth in documents such as the Provisional Measures for the Administration of Communication and Exchange in Medical Device Review, the Center for Medical Device Evaluation of the National Medical Products Administration gives priority handling to innovative medical devices and strengthens communication and exchange with applicants.
With regard to expert review meetings, the Center for Medical Device Evaluation has currently launched pilot programs in several provinces and municipalities, conducting such meetings remotely via video conferencing for applications submitted under the Special Review Procedure for Innovative Medical Devices. Enterprises are welcome to participate and engage in dialogue with the experts.
IV. Regarding Class I Medical Devices
In accordance with the Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 680), Class I medical devices are subject to filing-based management; therefore, this procedure does not apply to Class I medical devices.
V. Timing of the Implementation of the Newly Revised Procedures
The newly revised “Special Review Procedure for Innovative Medical Devices” has been in effect since December 1, 2018. For applications that were accepted but not yet reviewed prior to the implementation of the revised procedure, no supplementary submission of documentation or review under the new procedure is required; all other requirements shall be governed by the provisions of the newly revised procedure.
In view of the need to reassess whether innovative medical devices that have already agreed to undergo review under this procedure but have remained unregistered for an extended period continue to meet the relevant review criteria, the newly revised procedure now includes the requirement that “within five years after notification of the review outcome, any innovative medical device that has not been submitted for registration shall no longer be subject to review under this procedure.”
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Wenzhou Kangrui Bio-Technology Co., Ltd.
Wenzhou KanryBio Biotech Co., Ltd.
Address: No. 1 Jinlian Road, Longwan District, Wenzhou City, Zhejiang Province
Email:BD@kanrybio.com
Phone:0512-66026888
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