Weekly CFDA Updates(Jan 22-29, 2018)

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CFDA policies, regulation updates, QA/recall/AE, and new approvals in medical device and IVD for the week of Jan 22-29, 2018:

 

1. Policy:

CFDA announced Comprehensive Regulatory Plan for Medical Devices (2018-2020). Development plans for active device, passive device and IVD are addressed.

 

2. Regulation updates:

CFDA issued 9 industry standard documents, including:

  • Anesthesia: industry standard of oxygen humidifier
  • Dental: industry standard of hose assembles for dental pneumatics
  • Dental: industry standard of root canal preparation for dental use
  • Dental: industry standard of rotary polishing device for dental use
  • Diagnostics: industry standard of technical characteristics of c-arm x-ray
  • Hematology: industry standard of continuous hemodialysis machine
  • Orthopedics: industry standard of ultrasonic bone tissue surgery equipment
  • Sterilization: industry standard of products and processes of moist heat
  • Urology: industry standard of camera system for endoscope

 

3. QA/Recall/AE:

CFDA issued recall alerts for 59 devices. There are three imported devices:

  • Hologic: automatic nucleic acid detection system
  • Thermo Fisher: freezing microtome
  • Siemens: carbohydrate antigen assay kit

 

4. New Approvals:

CFDA issued the list of medical devices approved in December 2017, including 22 imported class III and 49 imported class II devices.

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