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2023 China NMPA Bluebook is here:

2022 Innovation Approvals Review: Cardiovascular, Gastro/Urology, Neurology, and Radiology among the Most


There have been 32 innovation approvals granted by the NMPA in 2022. Overseas manufacturer Medtronic, Ethicon and BioFire Diagnostics are on the list. Cardiovascular, gastro/urology, neurology, and radiology devices are among the most, scoring 8, 7, 6, 6 approvals respectively.

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.

Takeaways for Manufacturers

If the innovation 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:

  1. NMPA gives overseas manufacturers equal opportunity for the innovation channel. The qualifications are the same for domestic manufacturers as for overseas manufacturers.
  2. “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.

China Med Device has summarized NMPA innovation approvals into a table below. Contact us at to get the full information of any device you are interested in.

IndicationDevice Name (English)CompanyDomestic/Imported
CardiovascularThoracic aortic stent systemHangzhou WeiqiangDomestic
CardiovascularTranscatheter Implantable Leadless Pacing SystemMedtronicImported
CardiovascularTranscatheter prosthetic pulmonary valve systemHangzhou QimingDomestic
CardiovascularImplantable Left Ventricular Assist SystemHangtian TaixinDomestic
CardiovascularFlow-directing dense mesh stentAccu MedicalDomestic
CardiovascularLeft atrial appendage occluder systemHangzhou Denuo MedicalDomestic
CardiovascularIntravascular ultrasound diagnostic equipmentShenzhen Kaili BioDomestic
CardiovascularSingle-use intravascular ultrasound diagnosis catheterShanghai Aisheng BioDomestic
Ear, Nose, and ThroatENT dual-source cone beam computed tomography equipmentBeijing Langshi InstrumentDomestic
Gastroenterology and UrologyDigestive tract vibrating capsule systemShanghai Anhan MedcalDomestic
Gastroenterology and UrologyUltrasound diagnostic equipment for gastrointestinal endoscopyBeijing Huake ChuangzhiDomestic
Gastroenterology and UrologyDisposable cryoablation balloon catheterNingbo ShengjiekangDomestic
Gastroenterology and UrologyLaparoscopic surgery systemSuzhou Kangduo RoboticsDomestic
Gastroenterology and UrologyIntestinal polyps are assisted by electronic colonic endoscopic imagesChengdu weishi MedicalDomestic
Gastroenterology and UrologyOxidized Regenerated Cellulose (ORC) powderEthiconImported
Gastroenterology and UrologyAnastomosis reinforcement patchBeijing Bohui  BiotechDomestic
HematologyArtificial blood vesselsJiangsu BaiyoudaDomestic
MicrobiologyEncephalitis/meningitis multiple pathogen nucleic acid combination detection kitBioFire DiagnosticsImported
NeurologyDual-channel implantable deep brain stimulation systemBeijing Pinchi MedicalDomestic
NeurologyNavigation and positioning system for neurosurgeryBeijing Huake PrecisionDomestic
NeurologyImplantable spinal cord stimulation systemBeijing Pinchi MedicalDomestic
NeurologyImplantable rechargeable spinal cord stimulatorBeijing Pinchi MedicalDomestic
NeurologyPatient Programmable ChargerBeijing Pinchi MedicalDomestic
NeurologyIntracranial Aneurysm Surgery Planning SoftwareQianglian ZhichuangDomestic
OphthalmicAspheric diffractive multifocal intraocular lensAibonuode MeditechDomestic
OrthopedicHip replacement surgery navigation and positioning systemHangzhou Jiajian RoboticsDomestic
RadiologyCT image-assisted triage software for intracranial hemorrhageUnited ImagingDomestic
RadiologyMobile head and neck MRI systemFoshan RuijiatuDomestic
RadiologyMagnetic resonance imaging systemXingaoyi Medical EquipmentDomestic
RadiologyDisposable Intravascular Imaging CatheterHangzhou WeiqiangDomestic
RadiologyIntravascular imaging equipmentBeijing Quanjing HengshengDomestic
RadiologyGamma Beam Stereotactic Radiation Therapy SystemXi’an DaxiDomestic

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