Special Approval Procedures for Innovative Medical Devices in China
Recently overhauled CFDA regulations place an emphasis on ‘fast-track’ approval channel for medical devices. In February 2014, the China Food and Drug Administration released Trial
Unique Device Identification: A Global Perspective
The Unique Device Identification (UDI) System is intended to provide a single, globally harmonized system for identification of medical devices. It is expected to improve
CFDA Publishes New List of Medical Devices Exempt from Clinical Trial Requirements
On September 30, 2016, the China Food and Drug Administration (CFDA) has published a new list of medical devices exempt from clinical trial requirements in
Medical Device Single Audit Program (MDSAP) in Japan
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and
A review of the changes in ISO 13485
On February 25, 2016, the International Organization for Standardization (ISO) published its revisions to ISO 13485 replacing the previous version from 2003. This is the
‘’Overview of Authorization Procedures for Medicinal Products in Europe’’
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