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Fast-track Channel Review in 2021: Roche, CooperVision Got Priority Approvals

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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:

  1. Treat rare diseases with significant clinical application value,
  2. Diagnose or treat malignant tumors with significant clinical application value,
  3. Diagnose or treat geriatric diseases, no current effective diagnosis or treatment available in China yet,
  4. Indicated for pediatric diseases with significant clinical application value,
  5. Indicated for unmet medical needs, no current effective diagnosis or treatment available in China yet,
  6. 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:

  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.

For Emergency Approval, applicants for domestic or imported Class I/ Class II / Class III medical devices must meet one of the following scenarios:

  1. Indicated for a public health crisis, which currently has no effective product, or
  2. 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.

Complete list

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.

Priority Approvals

IndicationDeviceCompany
Clinical chemistryAnti-PD-L1 (SP142) rabbit monoclonal antibody reagent (immunohistochemical method)Roche
OphthalmicSoft hydrophilic contact lensCooperVision
OrthopedicOrthopedic surgery navigation and positioning systemBeijing Tianzhihang
MicrobiologyHepatitis B virus nucleic acid determination kit (RNA capture probe method)Shanghai Rendu
MicrobiologyRespiratory Pathogenic Bacteria Nucleic Acid Detection Kit
(Constant temperature amplification chip method)
Tianjin Baikang
RadiologyAuxiliary assessment software for bone age of children’s hand X-ray imagesHangzhou Yitu

Innovation Approvals

IndicationDeviceCompany
CardiovascularAnchored balloon dilatation catheterHunan Aipute Medical
CardiovascularIliac artery bifurcation stent systemShenzhen Xianjian Healthcare
CardiovascularTranscatheter aortic valve and retrievable delivery systemShanghai MicroPort
CardiovascularImplantable left ventricular assist system equipmentSuzhou Tongxin Medical Device
CardiovascularBranch intraoperative stent systemShanghai MicroPort
Clinical ChemistryPreimplantation Chromosome Aneuploidy Detection KitZhongyi Kangwei Bioscience
Clinical ChemistryContinuous Glucose Monitoring SystemWeitai Medical
Clinical ChemistryContinuous Glucose Monitoring SystemShenzhen Silicon
DentalDental implant surgery navigation and positioning equipmentYake Wisdom Technology
Gastroenterology & UrologyDisposable electronic ureteropelvic endoscopic catheterBeijing North Tengda Technology Development
Gastroenterology & UrologyUltrasonic diagnostic equipment for endoscopeShenzhen Yingmeida Medical
Gastroenterology & UrologyBiological Hernia Repair PatchZhongruan Medical Equipment
Gastroenterology & UrologyBiological Hernia Repair PatchSuzhou Zhuo Ruan
OphthalmicArtificial corneaBeijing Mih Medical
RadiologySingle-use intravascular imaging catheterSuzhou Argus Medical Technology

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