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Declaration of Conformity

Overview​

A Declaration of Conformity (DoC) is a formal document prepared and signed by the manufacturer that declares the medical device meets the applicable Essential Principles and that the appropriate conformity assessment procedures have been applied. A DoC is required for all medical device classes in Australia. For Class I and Class 1 IVD devices, the DoC is the primary conformity assessment document. For higher-class devices, the DoC accompanies the more detailed QMS certificates and product assessment certificates.

What a Declaration of Conformity Must Include​

Under Schedule 3 of the MD Regulations, an Australian Declaration of Conformity must include:

  • The manufacturer's name and address
  • A description of the medical device including its intended purpose
  • A statement that the device conforms with the Essential Principles
  • Identification of which conformity assessment procedures have been applied (reference to specific Schedule 3 parts)
  • Reference to the relevant standards applied (where applicable)
  • The name and title of the person authorised to sign on behalf of the manufacturer
  • Signature and date

The TGA does not publish a mandatory DoC template, but the EU Declaration of Conformity template is widely used and contains comparable information. Check TGA guidance for any Australia-specific requirements.

Who Signs the Declaration of Conformity​

The Declaration of Conformity must be signed by a person authorised by the manufacturer to make legally binding declarations on its behalf. This is typically a senior executive or an authorised quality manager. The signatory must understand the legal implications of the declaration — signing a false Declaration of Conformity can constitute an offence under the Therapeutic Goods Act 1989.

Keeping the Declaration of Conformity Updated​

The DoC must accurately reflect the current state of the device. If changes are made to the device that affect its compliance with the Essential Principles, or if new conformity assessment procedures are applied, the DoC must be updated and re-signed. The date on the DoC must reflect when the manufacturer last assessed and confirmed conformity.

Class I Devices — Self-Certification​

For Class I devices (other than Class Is and Class Im), the Declaration of Conformity is the sole conformity assessment document required. Class I manufacturers self-certify their compliance without third-party QMS certification or TGA review. This reflects the low-risk nature of these devices. The sponsor submits the DoC reference as part of the ARTG inclusion application.

Official Sources​