One submission for multiple markets a future reality?
The International Medical Device Regulators Forum (IMDRF) was created in February 2011 as a forum of medical device regulators from different regions around the world with the aim to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization.
The IMDRF members are Australia, Brazil, Canada, China, Europe, Japan, Russia, and USA.The latest development of the IMDRF is the creation of a Table of Contents (ToC) intended to provide a harmonised international electronic submission structure for the evaluation of medical device submissions. The ToC will act as a pilot trial to reduce burden on manufacturers to submit different medical device applications to the regulators of the IMDRF members.
The TGA is currently inviting applicants of Conformity Assessments to submit their applications using the ToC structure for the supporting data. Note, devices incorporating a medicine are out of scope for the IMDRF pilot.
This are very exciting news as it means that a single harmonised regulatory processes for the IMDRF country members could be a possible reality in the near future.
For any regulatory enquiries regarding medical devices and IVDs contact KD&A on +61 4 11 101 392 or email us at email@example.com.
November 2, 2017
September 4, 2017