I. Requirements Regarding 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, in China, an invention patent right to the core technology of the product. Given that applications for core technology invention patents may have been publicly disclosed by the patent administrative department under the State Council but ultimately not granted patent rights, we have introduced a preliminary evaluation of the product’s core technical solution.

The Patent Search and Consultation Center of the National Intellectual Property Administration is a directly affiliated unit of the National Intellectual Property Administration. Applicants may submit search requests to the Patent Search and Consultation Center.

To further encourage innovation and boost 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, we have determined that the application for special review of innovative medical devices must be submitted no later than five years from the date of the patent authorization announcement.

II. On the Method and Content for Notifying Review Results of Innovative Medical Devices

Applicants can check the review results by logging onto the National Medical Device Administration’s Center for Device Evaluation website and accessing the review progress inquiry page. The notification will include the review conclusion, the date of completion, reasons for disapproval (for disapproved items), and the regulatory classification (for approved items). After the newly revised procedures take effect, paper notifications will no longer be mailed.

III. On the Methods of Communication and Exchange for Innovative Medical Device Enterprises

In accordance with the principles of early engagement, dedicated responsibility, and scientific review, and guided by the requirements of documents such as the “Administrative Measures for Communication and Exchange in Medical Device Review (Trial),” the National Medical Device Administration’s Center for Device Evaluation gives priority processing to innovative medical devices and strengthens communication and exchange with applicants.

Regarding the expert review meetings, the Device Review Center is currently conducting pilot programs in selected provinces and cities. These meetings for specially reviewed innovative medical device applications are held via remote video conferencing, allowing companies to participate and engage in discussions with the experts.

IV. Regarding Class I Medical Devices

According to the “Regulations on the Supervision and Administration of Medical Devices” (Decree No. 680 of the State Council), Class I medical devices are subject to filing management; therefore, this procedure does not apply to Class I medical devices.

V. Regarding the timing of implementing 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 already accepted but not yet approved before the implementation of the revised procedure, there is no need to supplement the application materials or undergo review according to the newly revised procedure; all other requirements shall continue to be governed by the provisions of the newly revised procedure.

Considering that innovative medical devices that have already agreed to undergo review under this procedure but have remained unregistered for an extended period need to be reassessed to determine whether they still meet the relevant review criteria, the newly revised procedure now includes a requirement stating: “Within five years after being notified of the review results, innovative medical devices that have not been registered will no longer be subject to review under this procedure.”