Both risk classification and sub-classification are similar to the guidelines established by the GHTF
Within ICAO's GHTF
, Airports Council International World is working with IATA to ensure there is a sufficient body of best practice guidance for airport ground-handling procedures in the second edition of PANS - Aerodromes and to produce a new ground handling guidance manual.
(i) The organization GHTF
(was born in 1992) has been permanently replaced by the International Medical Device Regulators Forum (IMDRF) in 2011.
identified harmonization as a priority in recognition of the fact that the variation in these regulations from country to country creates additional work, costs and barriers for medical device manufacturers attempting to operate in the international arena.
Examples include ICH, GHTF
, ISO particularly ISO 13485 as well as European quality requirements.
to broaden the outlook towards the importance of quality following global harmonization Task Force (GHTF
) / International Medical Device Regulators Forum (IMDRF) guidelines.
As a result of these concerns, regulators from Australia, Canada, the European Union, Japan, and the United States of America have formed the "Global Harmonization Task Force" (GHTF
)--an organization tasked with harmonizing medical device regulations.
Food and Drug Administration (FDA), Global Harmonization Task Force (GHTF
), and the International Organization for Standardization (ISO).
Global Harmonization Task Force: Formed in 1992, the GHTF
was a voluntary group of representatives from national medical device regulatory authorities whose goal was to standardize global medical device regulation.