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China’s Green Pathway Registration for Innovative Medical Devices
Published on: March 16th, 2021
Innovative Green Pathway Definition
China’s NMPA created a registration route specifically for innovative medical devices called the Innovative Green Pathway in 2014 and is based on the CFDA Order No. 13 2014. Since this registration route tends to cause some confusion, specific clarifying details are provided below.
To begin with, it is important to note that the Green Pathway encompasses the same steps and requires the same documentation as a normal registration. It is also available to both foreign and domestic companies alike. However, the two advantages are the front-of-the line priority for reviewing, leading to an average 6-month shorter registration time, as well as a reviewer from the NMPA to provide guidance throughout the process. The reviewer acts as a valuable resource for back-and-forth discourse to ensure that no mistakes are made. Furthermore, there is no additional cost to apply, and the application can be submitted before the start of registration or can be done simultaneously. In 2020, a total of 197 applications were accepted by the NMPA and 54 received approval.
Criteria for Green Pathway Application
It begins with pre-assessment to determine whether the product is considered innovative, with a review time of 60 working days. After that, if the product is potentially innovative, it will then be posted on the NMPA website for 10 working days to see if any objections are expressed. After that time, the product will enter the Green Pathway registration route.
Medical devices must meet the following criteria to enter the Pathway:
- A class II or III medical device with notable clinical value; it can be the first of its kind, and/or a product that advances the global market
- A patent with China Patent & Trade Office coverage (cannot be older than 5 years), or a patent application under review at time of innovation Green Pathway application
- A preliminary study on prototype with complete and traceable data
- An authorized local legal entity
If the medical device fits within this criteria, certain documentation must be provided to apply including, but not limited to, the following:
- Product overview – development process and results
- Product Intellectual property rights
- Product technical documents (at least intended use)
- Novelty search report
- Academic papers summary
- Supporting documents illustrating clinical value
- Comparison to the clinical use of similar products
- Risk management report
- Instructions for Use (IFU)
- Mandatory Clinical Trial Information
Finally, a company must have a Chinese patent and work with a local China Legal Agent to submit this application. Asia Actual can help by preparing these required documents and submitting them to the NMPA for review. The period for this is typically 2-3 months. The product may also need to be shown to an expert panel for review. It should be noted that having an Innovation Device Designation does NOT mean approval, but the device will gain priority for registration.
The Innovative Green Pathway Advantages
Though the process of applying may be arduous with a success rate of 10%, the benefits of this registration route are considerable.
In the regulatory context, the NMPA will offer support by providing a reviewer to facilitate throughout the entire registration process, as well as expedite the lab testing and technical review time after the application submission. This is because a Green Pathway device will receive priority in the various steps of the registration process.
In a marketing context, products that go through the Innovative Green Pathway are unique, and this can be advantageous for sales and marketing and give an edge for future market competition. The product will also be officially listed on the NMPA website, granting exposure even before market entry.
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If you are considering applying for the Innovative Green Pathway for your medical device, contact Asia Actual today to help you navigate the application process.