Governance
DHSCA is committed to ensuring its own governance arrangements are robust, and meet the same expectations of the organisations and products it assesses.
The External Advisory Council (the Council) is the principal source of independent advice to DHSCA on the strategic direction of its work.
Expressions of interest to join the Council are now open.
Independence
DHSCA is a fully independent organisation. We are self funded and do not receive funding from any source other than the organisation we work with.
Assessment and accreditation decisions are held separate from any readiness engagement that DHSCA conducts with a health service organisation or vendor.
Participation in a readiness engagement confers no advantage in a later assessment. Clinical and technical assessors who support readiness activities must declare conflicts of interest, and cannot assess an organisation for which they have contributed advice to for a period of 5 years.
What DHSCA is not
An assessment by DHSCA is not a Therapeutic Goods Administration (TGA) approval and does not substitute for one.
We are not a regulatory body and where a product is a regulated medical device, the sponsor's and manufacturer's obligations under the Therapeutic Goods Act 1989 are unchanged.
Our assessments are designed to sit alongside existing regulatory compliance, in the substantial space where no existing regulation applies. Where we reasonably believe a product may require Software as a Medical Device regulation, we will refer you to the TGA