Medical Devices IMDRF Regulatory Approvals
The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.
It is a voluntary group of medical device regulators from around the world who have come together 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 and convergence.
IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum.
Medical device regulations in the KSA are based on Global Harmonization Task Force (GHTF) recommendations and registration in one of the founding GHTF countries (Australia, Canada, Europe, Japan, and/or the USA) is mandatory in order to register in the KSA.
All classes of medical devices and in-vitro diagnostics require registration with the SFDA.Bio-Standards can assist with gaining the right approvals & certificate for your Medical Devices in the Global Harmonization Task Force (GHTF) founding member’s jurisdiction (Australia, Canada, Europe, Japan, and/or the USA) through our international affiliations and offices .