By the end of 2020, 100 innovative medical devices have been approved by NMPA since the “Green Pathway” for innovative medical devices was created in 2014. This “Green Pathway” can highly accelerate the registration process in China.

Historical Review

1,471 products have applied for the innovative pathway, and 292 products have been granted innovative status (not market approval), accounting for about 20 percent of all applied. The number of approved innovative medical devices has been increasing year by year, with one innovative device approved in 2014, nine in 2015, 11 in 2016, 12 in 2017, 21 in 2018, 19 in 2019, and 26 in 2020.For the NMPA official description of the 26 innovative devices approved in 2020, please email ChinaMedDevice.com.

In terms of product category, there were 43 active devices, 37 passive devices, and 20 IVD reagents.

How to Qualify the Innovation Pathway

Three fast-track channels have been established by NMPA to encourage innovation and deal with unmet medical needs: Innovation Approval, Priority Review, and Emergency Approval.

The “Innovation Approval Procedure for Medical Devices” lists four criteria for domestic or imported Class II / Class III medical devices manufacturers to apply:

1. Provide significant clinical application value,
2. Own valid invention patent and have China Patent & Trade Office coverage,
3. Complete the preliminary study on a prototype with traceable data, and
4. Have an authorized in-country legal entity.

Key Takeaways for Overseas Manufacturers

Since domestic and overseas manufacturers have equal opportunity for this program, U.S. and European companies may not be taking full advantage. Among the 26 innovative devices approved in 2020, only three (just about 12%) were imported devices. Please email info@ChinaMedDevice.com to see if you are qualified to apply.

Overseas manufacturers have to bear in mind that:

1. NMPA gives overseas manufacturers equal opportunity for the “Green Pathway”. No difference as to the qualifications for domestic manufacturers vs. overseas ones.
2. “Conditional Approval” applies for urgently-needed medical devices. NMPA issue the “Guideline on Conditional Approval for Medical Devices” on December 20, 2019. It specifies that devices and IVDs indicated for life-threatening illnesses can be granted “Conditional Approval”, if the benefits of the products overweight the risks, and the manufacturers are committed to do further clinical research;
3. They can initiate innovation approval applications at same time when applying China Patent & Trade Office coverage. Application does not have to be made after getting the patent;

China Med Device has translated “Innovation Approval Procedure for Medical Devices” and other official NMPA documents into English as a service for its clients. Email info@ChinaMedDevice.com for details.