Three fast-track channels have been established by the NMPA to encourage innovation and deal with unmet medical needs: Innovation Approval, Priority Review, and Emergency Approval.
For Priority Review, applicants for domestic or imported Class II / Class III medical devices must 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, no current effective diagnosis or treatment available in China yet,
- Indicated for pediatric diseases with significant clinical application value,
- Indicated for unmet medical needs, no current effective diagnosis or treatment available in China yet,
- Be listed in National Science and Technology Major Projects or National Key R&D Plans
The “Innovation Approval Procedure for Medical Devices” lists four criteria for domestic or imported Class II / Class III medical devices:
- Provide significant clinical application value,
- Own valid invention patent and have China Patent & Trade Office coverage,
- Complete the preliminary study on a prototype with traceable data, and
- Have an authorized in-country legal entity.
For Emergency Approval, applicants for domestic or imported Class I/ Class II / Class III medical devices must meet one of the following scenarios:
- Indicated for a public health crisis, which currently has no effective product, or
- Indicated for unmet medical needs
Takeaways for Manufacturers
If one of the three fast-track statuses is granted (which does not mean “approval”), the device will be allocated to the “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, a specially assigned NMPA officer would check in and provide guidance throughout the expedited process.
Overseas manufacturers should bear in mind that:
- NMPA gives overseas manufacturers equal opportunity for the fast-track channels. The qualifications are the same for domestic manufacturers as for overseas manufacturers.
- “Conditional Approval” applies for urgently needed medical devices. NMPA issued 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 product overweigh the risks and the manufacturers are committed to doing further clinical research post market approval.
In 2021, six priority review devices and 15 innovation devices received approvals, while 50 devices were granted fast-track channels. Below are the approvals, in which Roche and CooperVision are on the list as imported devices.
|Clinical chemistry||Anti-PD-L1 (SP142) rabbit monoclonal antibody reagent (immunohistochemical method)||Roche|
|Ophthalmic||Soft hydrophilic contact lens||CooperVision|
|Orthopedic||Orthopedic surgery navigation and positioning system||Beijing Tianzhihang|
|Microbiology||Hepatitis B virus nucleic acid determination kit (RNA capture probe method)||Shanghai Rendu|
|Microbiology||Respiratory Pathogenic Bacteria Nucleic Acid Detection Kit|
(Constant temperature amplification chip method)
|Radiology||Auxiliary assessment software for bone age of children’s hand X-ray images||Hangzhou Yitu|
|Cardiovascular||Anchored balloon dilatation catheter||Hunan Aipute Medical|
|Cardiovascular||Iliac artery bifurcation stent system||Shenzhen Xianjian Healthcare|
|Cardiovascular||Transcatheter aortic valve and retrievable delivery system||Shanghai MicroPort|
|Cardiovascular||Implantable left ventricular assist system equipment||Suzhou Tongxin Medical Device|
|Cardiovascular||Branch intraoperative stent system||Shanghai MicroPort|
|Clinical Chemistry||Preimplantation Chromosome Aneuploidy Detection Kit||Zhongyi Kangwei Bioscience|
|Clinical Chemistry||Continuous Glucose Monitoring System||Weitai Medical|
|Clinical Chemistry||Continuous Glucose Monitoring System||Shenzhen Silicon|
|Dental||Dental implant surgery navigation and positioning equipment||Yake Wisdom Technology|
|Gastroenterology & Urology||Disposable electronic ureteropelvic endoscopic catheter||Beijing North Tengda Technology Development|
|Gastroenterology & Urology||Ultrasonic diagnostic equipment for endoscope||Shenzhen Yingmeida Medical|
|Gastroenterology & Urology||Biological Hernia Repair Patch||Zhongruan Medical Equipment|
|Gastroenterology & Urology||Biological Hernia Repair Patch||Suzhou Zhuo Ruan|
|Ophthalmic||Artificial cornea||Beijing Mih Medical|
|Radiology||Single-use intravascular imaging catheter||Suzhou Argus Medical Technology|