GLOBAL MEDICAL DEVICE REGISTRATION: IMPACT OF CHANGES TO THE EU MDR AND CHINESE GCP ON MANUFACTURERS

Medical device safety and efficacy is a top priority for manufacturers, healthcare providers and regulators around the globe. The European Union recently passed updated regulations for medical device and in-vitro diagnostics, while the China Food and Drug Administration (CFDA) has enacted “The Good Clinical Practices for Medical Device Clinical Trials”. The EU requirements define clear responsibilities for manufacturers to track the quality and capability of devices, while the changes in China represent an ongoing initiative to have greater alignment with EU device regulations. Both developments represent landmark legislation intended to protect the rights of patients while demonstrating devices are supported by accurate data. This will ultimately affect all manufacturers looking to register products in Europe and China, as regulatory teams will need to develop an inclusive global strategy to ensure success.

Speakers:
Gert Bos
Executive Director and Partner
Qserve Group

Xiaoli Gou
Junior Consultant
Qserve Group