In an effort to ensure quality and safety for both multinational and domestic medical devices, the Chinese Food and Drug Administration (CFDA) and the National Health and Family Planning Commission (NHFPC) have jointly published updated guidelines on medical device clinical trial supervision and management. The documents, officially titled “Good Clinical Practice for Medical Devices,” will go into effect in June 2016. The documents provide guidance on how sponsors should prepare for the medical device clinical trial process and lay out specific responsibilities and expectations. In vitro diagnostic reagents that are classified as medical devices are not covered in the update.
Major points of the text include:
- General protocol and principles of device trials intended for obtaining Chinese regulatory approval.
- Definition of the sponsor as the manufacturer of the device. Previously, the sponsor was defined as the applicant that filed the registration.
- Responsibilities of ethics committees, sponsors, clinical trial institutions, and investigators.
- Protections of rights and benefits of trial subjects.
- How to manage investigational medical devices and essential documents.
- Trial sites must hold data and materials for 10 years after the trial has been completed.