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CFDA: Imported Medical Devices Only Account For 15% of Innovation Approvals


CFDA granted innovation approval status for 28 medical devices in the first half of the year, covering the indication of cardiovascular (10), oncology (7), orthopedic (5), immunology (4) and urology (2).

Only 4 imported devices, or 15%, have been granted for the innovation pathway:

  • Edwards Lifesciences: transcatheter heart valve
  • BioFire Diagnostics: encephalitis/meningitis multi-pathogen nucleic acid detection kit
  • Medtronic: percutaneous implanted aortic valve system
  • Biosense Webster (subsidiary of J & J): 3D multichannel radiofrequency balloon catheter


China Med Device, LLC is experienced in handling innovation approvals and priority reviews. For regulatory or commercialization services, please email

Complete list of innovation approvals in 2018 as follow:

  • United Imaging: medical linear accelerator system
  • Edwards Lifesciences: transcatheter heart valve and accessory
  • Bohui: Repair patch with anastomotic stoma
  • RaySoultion: positron emission and X-ray tomography scanning system
  • Shanghai Remedicine: steep pulse irreversible electroporation machine
  • BioFire Diagnostics: encephalitis/meningitis multi-pathogen nucleic acid detection kit
  • Microport: eluting coronary stent
  • Anhan Medtech: capsule endoscopy system
  • Chunli Orthopedic: unicompartmental knee prosthesis
  • Chunli Orthopedic: joint replacement prosthesis
  • Origin Medtech: polymer clamp
  • ZhiGeno: echinococcus spp. serological reagent
  • NovoGene: EGFR t790m mutation reagent
  • Suzhou RainMed: Coronary blood flow reserve system
  • Shanghai Superchip: Helicobacter pylori 23S rRNA gene mutation detection kit
  • Beijing Med-Zenith: Transcatheter pulmonary valve and delivery system
  • Beijing CuraCloud: Coronary physiological function assessment software
  • United Imaging: Digital mammography
  • Hangzhou NewHorizonBio: KRAS gene mutation and BMP3/NDRG4 gene methylation and occult blood combined detection kit
  • Medtronic: percutaneous implanted aortic valve system
  • Biosense Webster (subsidiary of J & J): 3D multichannel radiofrequency balloon catheter
  • Quanjing Hengsheng: intravascular imaging system
  • Aipute: pressure-induced ablation catheter
  • Genomics: BRCA1/2 gene mutation detection kit
  • Xiansida: oligosaccharide detection kit
  • Hangtian Taixin: ventricular assist device
  • Seemine SMA: memory alloy wrist fixator
  • Shenzhen Jingcheng: magnesium-degradable bone repair material


CFDA issued Innovation Approval Draft Guideline on May 7, 2018. All medical device and IVD product must meet all the following criteria to be qualified for the innovation pathway:

  • Class II / Class III Medical Device with significant clinical application value,
  • Own valid invention patents,
  • Have China PTO coverage,
  • Complete the preliminary study on prototype with traceable data, and
  • An authorized in-country legal entity.


For complete version of the draft guideline, please email

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About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are certified as legal agent. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies’ success.

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