Unique Device Identification (UDI) Systems Expansion in Europe

The implementation of Unique Device Identification (UDI) systems in markets beyond the US is increasing, as the European Commission is planning to publish a guidance document on UDI under the MDR and IVDR in March 2018. It became clear that most markets will have a UDI system within five years . Although it will be […]

FDA-First Agency to Release a Guidance on 3D Printed Products

To keep up with evolving 3D printing technology and to encourage and support innovation in this field, the FDA has released it first technical guidance for manufacturers using 3D-printed technology for medical products that include devices, medication and human tissue. The guidance provides a comprehensive policy framework to manufacturers and a more efficacious pathway to […]

CFDA New Clinical Data Requirements for Foreign medical devices

CFDA has proposed changes to Order 650 that would exempt additional types of Class II and III medical devices and IVDs from clinical trial requirements, and allow greater acceptance of clinical data from foreign countries in registration applications. The main changes to CFDA foreign clinical data acceptance criteria are as follows: Foreign clinical trials must […]

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 global standard for medical device quality management systems (QMS). Over the next three years, ISO 13485:2003 and ISO 13485:2016 will coexist, allowing manufacturers, accreditation/certification bodies and regulators time to transition […]