China Innovative Device Status: Only 20% Claimed by U.S./ European Manufacturers

2020-02-09

Only one out of five medical devices granted Innovative Device Status by NMPA in 2019 were imported. Since domestic and overseas manufacturers have equal opportunity for this program, U.S. and European companies may not be taking full advantage.

Innovative Device Status is one of three fast-track channels, along with Emergency Approval and Emergency Review, that NMPA has established to encourage innovation and deal with unmet medical needs: Being granted status can significantly shorten the time for market introduction.

Of the 39 medical devices granted innovation device status in 2019, only eight (just 20%) were imported devices. One of those is Cardiovascular Systems, a company represented by Bradynuoen.

Full List of Imported Innovation Devices in 2019

Cardiovascular & Pulmonology

Cardiovascular Systems: Coronary orbital rotary grinding intervention system
Conavi Medical: Intravascular ultrasound optical coherence tomography system
Sensible Medical Innovations: Lung water measuring instrument

Hematology

Ethicon: Regenerative oxidized cellulose absorbance hemostatic powder
Pulsar Vascular: Bifurcation aneurysm vascular reconstruction device
Sequent Medical: Self-expanding aneurysm embolization system

Dental

Institut Straumann: Ceramic dental implant system

Oncology

NovoCure: Tumor electric field therapy instrument

Apart from Cardiovascular Systems’ coronary orbital rotary grinding intervention system, China Med Device conducted clinical trials for United Imaging’s CT-Linac, a combination of CT and accelerator for cancer radiotherapy. NMPA granted Innovation Approval to CT-Linac in December 2018. Email info@inspirativemed.com to see if you are qualified to apply.

What’s Innovation Approval and How to Apply

The final version of “Innovation Approval Procedure for Medical Devices” published on November 5, 2018 lists four criteria for manufacturers to apply:

Provide Class II / Class III medical device with significant clinical application value,
Own valid invention patent and have China Patent & Trade Office coverage,
Complete the preliminary study on prototype with traceable data, and
Have an authorized in-country legal entity.

If the “Innovation Device Status” is granted (which does not mean “approval”), the device will be allocated ‘front-of-queue’ priority throughout the registration process. The granted priority affects the classification determination, pre-clinical testing, QMS auditing, and CFDA reviewing/approving processes. Meanwhile, a specially-assigned NMPA officer would check in and provide guidance throughout the whole expedited process.

Three Fast-Track Channels

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

For Priority Review, applicants have to meet one of the following scenarios:

Treat rare diseases with significant clinical application value,
Diagnose or treat malignant tumors with significant clinical application value,
Diagnose or treat geriatric diseases, which currently have effective diagnosis or treatment
Be intended for pediatric diseases with significant clinical application value,
Be intended for unmet medical needs, which currently have effective diagnosis or treatment, or
Be listed in National Science and Technology Major Projects or National Key R & D Plans

For Emergency Approval, have to meet one of the following scenarios:

Be intended for public health crises, which currently effective product, or
Be intended for unmet medical needs

Tips for Overseas Manufacturers

Overseas manufacturers have to bear in mind that:

NMPA gives overseas manufacturers equal opportunity for the fast-track channels. No difference as to the qualifications for domestic manufacturers vs. overseas ones.
“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 overweigh the risks, and the manufacturers are committed to do further clinical research;
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;
Having been granted “status” does not mean “approval”. With ‘front-of-queue’ priority, they still have to go through the normal review process.

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