Rotec – The Customization Expert for Production Sample Library Consumables

Release date:

2025-03-01

One of the review criteria for innovative medical devices is that the applicant must legally hold the invention patent rights to the product's core technology in China. Considering that applications involving core technology invention patents may have already been publicly disclosed by the Patent Administration Department of the State Council, yet ultimately failed to receive patent authorization, we are introducing an additional pre-evaluation process for the product’s core technical solutions.

I. Requirements Regarding Patents in the Special Review Procedure for Innovative Medical Devices

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

To further encourage innovation and stimulate R&D vitality among medical device manufacturers, and considering the unique characteristics of patents as well as the average development cycle for medical devices, we have determined that the application for a special review of innovative medical devices must be submitted no later than 5 years from the date of the patent authorization announcement.

II. Regarding the Notification Method and Content for Review Results of Innovative Medical Devices

Applicants can check the review results by logging into the National Medical Device Evaluation Center’s website and accessing the review progress inquiry page. The information provided will include the review conclusion, completion date, reasons for disapproval (for items not approved), and management category (for items approved). After the newly revised procedures are implemented, paper notifications will no longer be mailed out.

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

The National Medical Device Review Center, guided by the principles of early engagement, dedicated personnel responsibility, and scientific review, prioritizes the evaluation of innovative medical devices in accordance with relevant requirements such as the "Provisional Measures for Communication and Exchange in Medical Device Review and Approval," while also enhancing communication and collaboration with applicants.

Regarding the expert review meetings, the Device Review Center has currently launched pilot programs in select provinces and cities, conducting special review meetings for submitted innovative medical device applications via remote video conferencing. Companies can participate and engage in discussions with the experts.

IV. Regarding Class I Medical Devices

According to the "Medical Device Supervision and Administration Regulations" (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 already accepted but not yet approved before the implementation of the new procedure, there is no need to resubmit supplementary documentation or undergo review under the revised process; all other requirements, however, must comply with 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 must be reassessed to determine whether they still meet the relevant review criteria, the newly revised procedure now includes a requirement stating: "Innovative medical devices that remain unregistered within 5 years after being notified of the review outcome will no longer be subject to review under this procedure."

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