NMPA granted priority review designation to CooperVision and Biomerieux on September 30, and gave its reason as below:
- soft hydrophilic contact lens, by CooperVision, on the ground that it is indicated for children, and it has substantial clinical advantages
- Ceftazidime/Avibactam concentration gradient agar diffusion drug sensitivity strip, by Biomerieux, on the ground of its urgent clinical needs, and that there is no predicate product registered in China
China Med Device developed clinical evaluation report (CER), supplemented with seven-site clinical trial data for Magnetic Resonance Imaging (MRI) guided radiotherapy system, a newly approved priority review device. If you have similar device or are interested to know more please email info@ChinaMedDevice.com.
How to Get the Designation
For Priority Review, applicants need 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, with no 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
If the “Priority Review Device Designation” 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 NMPA reviewing/approving processes. Meanwhile, an assigned NMPA officer would check in and provide guidance throughout the whole expedited process.
Key Takeaways for Overseas manufacturers
Overseas manufacturers have to bear in mind that:
- NMPA gives overseas manufacturers an 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 “designation” does not mean “approval”. With ‘front-of-queue’ priority, they still have to go through the normal review process.
For other NMPA fast-track channels, please click HERE.