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Monthly CFDA News Roundup (Mar 2018)


Monthly CFDA News Roundup covers government reports, regulations, QA/recall/AE, and new approvals in medical device and IVD in China.  It is edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.


  1. CFDA’s name is disappearing as China announces cabinet reshuffle plan.
  2. CFDA forum held to discuss 3D printed device draft guideline. Software issues, raw material powder issues, printer management and access requirements for 3D printed device were discussed.
  3. 9 medical devices granted innovation approval; No foreign manufacturers on the list.

Government Report

Registration: CFDA published Medical Device Registration Report for 2017. In the year of 2017, 2,823 imported class II and 2,800 imported class III medical devices and IVDs registered. The top five imported device categories registered are: implantable materials and artificial organs, optical and endoscopic equipment, dental materials, medical polymer materials, and major electronic equipment. The top five countries exporting medical devices and IVDs to China are: US (1,469), Germany (827), Japan (404), UK (237) and Korea (195).


  1. CFDA held industry forum for additive manufactured (3D printed) medical device. 70 technicians, manufacturers and CFDA reviewers attended the forum. Software issues, raw material powder issues, printer management and access requirements for 3D printed device were discussed for 3D printed device technical review draft guideline. For the English draft guideline, please email
  2. CFDA issued 6 Technical Review Guideline in March 2018:
  • Active: Technical Review Guideline on Rigid Optical Endoscope
  • Active: Technical Review Guideline on Optical Coherence Tomography System
  • Active: Technical Review Guideline on Femtosecond Laser System
  • Active: Technical Review Guideline on Diagnostic Ultrasound System
  • Active: Technical Review Guideline on Continuous Glucose Monitor
  • IVD: Technical Review Guideline on Cell Mediated Immune Response Assay for Mycobacterium Tuberculosis


  1. QA: CFDA issued 3 Adverse Event Notification for reusable uterine sound and hyaluronic acid.
  2. Recall: CFDA announced recall notices from 27 foreign manufacturers for 41 medical devices. GE, Philips, Siemens, Edwards, Hologic, Boston Scientific and Smith & Nephew are on the list. For the complete recall list with reasons for recall, please email

New Approval

  1. CFDA granted innovation approvals to 7 domestic manufacturers for 9 medical devices and IVDs, covering cardiology, orthopedics, oncology and immunology.
  • MicroPort: eluting coronary stent
  • MicroPort: revascularization system
  • Anhan Medtech: capsule endoscopy system
  • Chunli Orthopedic: unicompartmental knee prosthesis
  • Chunli Orthopedic: joint replacement prosthesis
  • Origin Medtech: polymer clamp
  • GeneBio Health: RT-PCR detection assay
  • ZhiGeno: echinococcus spp. serological reagent
  • NovoGene: EGFR t790m mutation reagent
  1. CFDA published directory of registered medical devices for Feb 2018. 20 imported class III and 18 imported class II devices have been approved. Medtronic, Abbott, Philips, Beckman Coulter are on the list.

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, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.

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