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As part of the conformity assessment procedures, the manufacturer of a medical device is required to make a declaration of conformity which declares that the device complies with:
- the applicable provisions of the essential principles
- the classification rules
- an appropriate conformity assessment procedure
The declaration also requires the manufacturer to provide details that are relevant to the conformity assessment procedure and the manufacture of the medical device covered by the declaration.
The following table outlines which declaration of conformity requires completion.
| Class of medical device | Conformity assessment procedure required under Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) | Directive 93/42/EEC on Medical Devices - European Union equivalent | Declaration of conformity required under Schedule 3 of the Regulations |
|---|---|---|---|
| Class I (including export only) | Part 6 (Declaration of conformity procedures) | nil | Schedule 3, Part 6, clause 6.6 |
| Class I (measuring) | Part 1 excluding clause 1.6 (Full quality assurance procedures) OR | Annex II.3 OR | Schedule 3, Part 1, clause 1.8 OR |
Part 6 (Declaration of conformity procedures) + Part 3 (Verification procedures) or Part 4 (Production quality assurance procedures) or Part 5 (Product quality assurance procedures) | nil + Annex IV or Annex V or Annex VI | Schedule 3, Part 6, clause 6.6 | |
| Class I (sterile) | Part 1 excluding clause 1.6 (Full quality assurance procedures) OR | Annex II.3 OR | Schedule 3, Part 1, clause 1.8 OR |
| Part 6 (Declaration of conformity procedures) + Part 4 (Production quality assurance procedures) | Nil + Annex V | Schedule 3, Part 6, clause 6.6 | |
| Class IIa | Part 1 excluding clause 1.6 (Full Quality Assurance Procedures) OR | Annex II.3 OR | Schedule 3, Part 1, clause 1.8 OR |
Part 6 (Declaration of conformity procedures) or Part 4 (Production quality assurance procedures) or Part 5 (Product quality assurance procedures) | Nil or Annex V or Annex VI | Schedule 3, Part 6, clause 6.6 | |
| Class IIa (sterile) | Part 1 excluding clause 1.6 (Full quality assurance procedures) OR | Annex II.3 OR | Schedule 3, Part 1, clause 1.8 OR |
| Part 4 (Production quality assurance procedures) (excluding clause 4.7) | Annex V | Schedule 3, Part 6, clause 6.6 | |
| Class IIb | Part 1 excluding clause 1.6 (Full quality assurance procedures) OR | Annex II.3 OR | Schedule 3, Part 1, clause 1.8 OR |
Part 3 (Verification procedures) OR | Annex IV OR | Schedule 3, Part 3, clause 3.5 OR | |
Part 4 (Production quality assurance procedures) OR | Annex V OR | Schedule 3, Part 4, clause 4.7 OR | |
| Part 5 (Product quality assurance procedures) + Part 2 (Type examination procedures) | Annex VI + Annex III | Schedule 3, Part 5, clause 5.7 | |
| Class IIb (sterile) | Part 1 excluding clause 1.6 (Full quality assurance procedures) OR | Annex II.3 OR | Schedule 3, Part 1, clause 1.8 OR |
| Part 4 (Production quality assurance procedures) + Part 2 (Type examination procedures) | Annex V + Annex III | Schedule 3, Part 4, clause 4.7 | |
| Class III | Part 1 (Full quality assurance procedures) OR | Annex II.3 OR | Schedule 3, Part 1, clause 1.8 OR |
Part 3 (Verification procedures) OR | Annex IV OR | Schedule 3, Part 3, clause 3.5 OR | |
| Part 4 (Production quality assurance procedures) + Part 2 (Type examination procedures) | Annex V + Annex III | Schedule 3, Part 4, clause 4.7 | |
| Class III (sterile) | Part 1 (Full quality assurance procedures) OR | Annex II.3 OR | Schedule 3, Part 1, clause 1.8 OR |
| Part 4 (Production quality assurance procedures) + Part 2 (Type examination procedures) | Annex V + Annex III | Schedule 3, Part 4, clause 4.7 | |
| AIMD | Part 1 (Full quality assurance procedures) OR | Annex 2.3 OR | Schedule 3, Part 1, clause 1.8 OR |
Part 3 (Verification procedures) OR | Annex 4 OR | Schedule 3, Part 3, clause 3.5 OR | |
| Part 4 (Production quality assurance procedures) + Part 2 (Type examination procedures) | Annex 5 + Annex 3 | Schedule 3, Part 4, clause 4.7 | |
| System or Procedure Packs | Part 7 (Procedures for medical devices used for a special purpose) | Annex VIII and Article 12 |
Schedule 3, Part 1 clause 1.8
- Template: Manufacturer's declaration of conformity - full quality assurance procedure (rtf,57kb)
Declaration made in accordance with the requirements of Clause 1.8 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
Schedule 3, Part 3, clause 3.5
- Template: Manufacturer's declaration of conformity - verification (rtf,54kb)
Declaration made in accordance with the requirements of Clause 3.5 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
Schedule 3, Part 6, clause 6.6
- Template: Manufacturer's declaration of conformity - Clause 6.6 (rtf,61kb)
Declaration made in accordance with the requirements of Clause 6.6 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002 - For Class I non-sterile non-measuring devices you can use this version of the Clause 6.6 (docx,34kb)
Declaration made in accordance with the requirements of Clause 6.6 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002. Further information for completing this template can be found in the Guidance for declaration of conformity for Class I medical devices.
Schedule 3, Part 4, clause 4.7
- Template: Manufacturer's declaration of conformity - production quality management system (rtf,59kb)
Declaration made in accordance with the requirements of Clause 4.7 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
Schedule 3, Part 5, clause 5.7
- Template: Manufacturer's declaration of conformity - product quality management system (rtf,57kb)
Declaration made in accordance with the requirements of Clause 5.7 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
Schedule 3, Part 7, clause 7.5
- Template: Manufacturer's Declaration of Conformity for Class I medical devices and Class 1 IVD system or procedure packs (docx,40kb)
Declaration made under Clause 7.5 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002 - Template: Manufacturer's Declaration of Conformity for system or procedure packs (other than Class I or Class 1 IVD system or procedure packs) (docx,42kb)
Declaration made under Clause 7.5 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002