AHWP Proposes Regulating Health Software as Medical Devices, With Eye to Harmonization

The Asian Harmonization Working Party (AHWP), a regulatory group focused on the harmonization of regulations across Asia and various other emerging economies, has released for comment a new white paper regarding medical device software regulation in which it proposes the future regulation of software as a medical device (SaMD).

The paper notes the need to identify and assess medical software according to its "risk profile" in order to "determine the degree of regulatory control necessary" for the particular device.

There is a further lack of guidelines to allow AHWP's member economies to assess the appropriateness of their respective software controls relative to other economies, the white paper explains.

The aim of the paper, AHWP writes, is to assess the software regulatory approaches taken by various regulatory bodies and jurisdictions—Australia, China, the EU, Canada, Japan and the US—in the hopes of developing a proposed regulatory framework that can be harmonized between AHWP member economies.

AHWP concludes:

"It is proposed that the next steps for the AHWP would be to adopt a position on the qualification and classification of SaMD, with a view to align as far as possible to global harmonisation or convergence of SaMD guidelines. Following which, development of regional documentation or guidance on software qualification and definition, submission format and software change evaluation, as well as maintain follow-up with developments in medical device regulatory activities, internationally. "

The group also says it will keep a close eye on the work of the International Medical Device Regulators Forum (IMDRF) so as to "ensure a harmonized approach in software regulatory controls, globally."

Comments on the white paper will be accepted until 1 September 2014.

AHWP White Paper