Medical Device Blog – QA & Regulatory Updates

Posted on January 26, 2012. Filed under: Uncategorized |

Update 12/20/2011: According to Emergo Group sources in Beijing, the waiver policy was instituted by the Beijing FDA (BFDA) rather than the SFDA. Furthermore, the policy applies only to domestic medical devices in China, not imports.
China’s State Food and Drug Administration (SFDA) has waived local clinical trial requirements for 21 types of Class II medical devices equivalent to products currently on the Chinese market.
 To qualify for the waiver, applicants must provide SFDA authorities with “comparative illustrations” of how their devices are equivalent to devices already approved in China. Evidence of equivalence should include data about a device’s functionality, manufacturing materials and composition, and technical performance indicators. Information regarding a device’s sterilization methods, expected uses and household uses should also be included.
The types of devices eligible for the waiver include:
  • Surgical Instruments
  • Orthopedic Surgical Instruments
  • Injection and Puncture Instruments
  • General Examination Instruments
  • Electrical Medical Devices
  • Optical and Endoscopic Devices
  • Ultrasonic Devices
  • Traditional Chinese Medical Devices
  • X-ray Parts and Equipment
  • Clinical Lab Testing Equipment
  • Cardiopulmonary Bypass and Circulation Equipment
  • ER and operational equipment
  • Stomatology Equipment
  • Ward Room Equipment
  • Cold Therapy and Low Temperature Storage Equipment
  • Stomatology Materials
  • Medical Health Dressing
  • Polymer Materials
In place since late November, the SFDA’s new policy should streamline many Class II device manufacturers’ paths to market in China. 

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