Declaration of Helsinki (ethical principles for medical research involving human subjects)
International ethical principles for medical research with human subjects. The medical device regulations require investigations done outside Australia to follow its principles.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| Australia | Referenced | - | - | Mandatory for clinical investigation data collected outside Australia, as part of the clinical evaluation procedures. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: ISO 14155, E6(R3), E8(R1), E9(R1), NHMRC National Statement. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.