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Monthly CFDA News Roundup (Feb 2018)


Monthly CFDA News Roundup covers policies, 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. New 3D printed medical device draft guideline will propel China to leadership in orthopedic and dental application. More
  2. Overseas inspection intensifies. 37 observations have been found and 8 foreign manufactures are on the list. More
  3. Unique Device Identification draft plan has been published to identify medical devices within China.



UDI: CFDA announced Unique Device Identification (UDI) draft plan to adequately identify medical devices through their distribution and use. When fully implemented, the label of all devices in China will include a unique device identifier in human- and machine-readable form. Feedbacks need to be submitted by Apr 30.



CFDA issued 7 Technical Review Guideline in Feb 2018:

  • IVD: Technical Review Guideline on epidermal growth factor receptor (EGFR) gene mutation assay
  • IVD: Technical Review Guideline on helicobacter pylori antigen/antibody assay
  • IVD: Technical Review Guideline on anti-human globulin assay
  • IVD: Technical Review Guideline on nucleic acid assay for enterovirus RNA
  • Active: Technical Review Guideline on computed tomography x-Ray system (CT)
  • Active: Technical Review Guideline on ultrasonic cutting and coagulation system for soft tissue
  • Passive: Technical Review Guideline on 3d printed medical device (draft)
  • Others: Technical Review Guideline on medical devices for rare diseases (draft)



  1. QA: CFDA issued national quality notice #49 and identified 8 types of medical devices with quality issues: RF ablation system, X-ray imaging system, oxygen concentrator, biomedical freezer, surgical blade, etc. More
  2. Inspection: CFDA announced overseas inspection results from 8 foreign medical device manufacturers with 37 observations. Companies from Switzerland, US, Australia and Japan have been impacted.
  3. Recall: CFDA announced recall notices from 36 medical device manufacturers. Philips, Edwards, Hologic, Boston Scientific and Smith & Nephew are on the list.


New Approval

  1. Shanghai CFDA office published approval notice to portable ECG recorder on Feb 27. The device is registered by Yuanxin Medtech and manufactured by MicroPort EP MedTech. It is the first approval granted through marketing-authorization holders program. More
  2. CFDA published directory of registered medical devices for Jan 2018. 20 imported class III and 31 imported class II devices have been approved. Medtronic, Roche, Abbott, Philips, Bayer and Beckman Coulter are on the list.


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