Smartphone apps need scrutiny
THE smartphone market represents a challenge of “enormous complexity” for regulators, the TGA has acknowledged amid belated moves to tackle the explosion in health- and medical-related apps.
The TGA is part of a push to improve the oversight of therapeutic-related apps headed by the Global Harmonization Task Force (GHTF), a body set up to standardise the regulation of medical devices across member countries.
A TGA spokesperson said work was ongoing with the GHTF to introduce a “harmonised approach” to the oversight of apps among members, which include the US, Japan, Canada and European nations.
“The report of that [GHTF] working group identified the enormous complexity involved in attempting to regulate this area,” a TGA spokesperson told MO.
“In the wider context, medical device regulators around the world are considering the appropriate regulation for the expanding development and