Medical Devices

The legal framework for medical devices in China has changed so much since 2014. There are a series of new orders, announcements and documents drafted and released by China Food and Drug Administration (CFDA) after the promulgation of State Council Order No. 650 Regulations for the Supervision and Administration. The medical devices exported to China will face to the new classification based on their hazard potential, the new registration flowchart and new doubts in the preparation of registration dossier. Our Knoell Shanghai office will provide up to date regulatory change information, professional toxicology support and registration dossier preparation services.

  • Regulatory support of medical devices registration in China
  • Regulatory toxicology support in China, such as biocompatibility evaluation report, expert statement, scientific testing and registration advices
  • Support in all stages of your medical devices registration in China
  • Literature research and data gap analysis
  • Developing registration and testing strategies
  • Audit, communication and negotiation with test facilities or laboratories in China
  • Study monitor in China
  • Dossier translation