Compliance with China SFDA Medical Device and Pharmaceutical/Drug Regulations

China's State Food and Drug Administration (SFDA) is the main regulatory body responsible for regulating medical devices and pharmaceuticals in China.

Some of the main SFDA pharmaceutical/drug regulations include the following:

  • Drug Administration Law of the People's Republic of China
  • Regulations for Implementation of the Drug Administration Law of the People�s Republic of China
  • Regulations on Administrative Protection for Pharmaceuticals

Some of the main SFDA medical device regulations include the following:

  • Regulations for the Supervision and Administration of Medical Devices
  • Provisions of Medical Device Classification
  • Provisions for Clinical Trials of Medical Devices

Pacific Bridge Medical can make sure your medical company is compliant to these local regulations and can provide you with the appropriate regulatory or business strategy. We can also help you register your medical product in China.

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