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 about 20%) were imported devices. One of those is Cardiovascular Systems, a company represented by China Med Device, LLC.
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
- Ethicon: Regenerative oxidized cellulose absorbance hemostatic powder
- Pulsar Vascular: Bifurcation aneurysm vascular reconstruction device
- Sequent Medical: Self-expanding aneurysm embolization system
- Institut Straumann: Ceramic dental implant system
- 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 (Click HERE), a combination of CT and accelerator for cancer radiotherapy. NMPA granted Innovation Approval to CT-Linac in December 2018. Email info@ChinaMedDevice.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” (click HERE) 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
- Treat rare diseases with significant clinical application value,
- Diagnose or treat malignant tumors with significant clinical application value,
- Diagnose or treat geriatric diseases, which no 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 no 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
- Be intended for public health crises, which currently have no effective product, or
- Be intended for unmet medical needs
Tips for Overseas
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.
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.