Weekly CFDA News Roundup (May 13th to May 19th)

Weekly CFDA News Roundup (May 6th to May 12th)
May 15, 2018
Weekly CFDA News Roundup (May 20th to May 26th)
May 29, 2018

Weekly CFDA News Roundup (May 13th to May 19th)

Weekly CFDA News Roundup covers policies, industry standards, guidance, 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.

Standard

CFDA issued “2018 Medical Device Industry Standard Revision Plan” for feedback. The Plan covers 99 industry standards for medical devices, IVDs, such as mass spectrometer, assisted reproduction device and 3D printed dental device.

For English version of the Plan, please email info@ChinaMedDevice.com.

Guideline

CFDA issued 4 guidelines on May 18:

  • Active device: Technical Review Guideline on Surgical Microscope
  • Active device: Technical Review Guideline on Tonometer
  • Active device: Technical Review Guideline on Pulse Wave Velocity and Ankle-Brachial Index Product
  • Passive device: Technical Review Guideline on Cleaning Bench

QA/Recall/AE

CFDA announced a class I recall notice to implantable defibrillator by Abbott. Class I recall is the most urgent type of recall CFDA issues. For the reason of recall and the model number, please email info@ChinaMedDevice.com.

Approval

CFDA published directory of registered medical devices for April 2018. 52 domestic class III, 23 imported class III and 32 imported class II medical devices have been approved. GE, Siemens, Medtronic, Abbott, Johnson & Johnson, BD, Baxter are on the list.

 

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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, 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+ companies’ success.