Declaration of conformity templates (medical devices)
5 February 2013
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 | 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) |
Nil |
||
| 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 |
||
| 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 |
||
| 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) |
Annex VI |
||
| 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) |
Annex V |
||
| 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) |
Annex V |
||
| 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) |
Annex V |
||
| 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) |
Annex 5 |
||
| System or Procedure Packs |
Part 7 (Procedures for medical devices used for a special purpose) |
Annex VIII & Article 12 | Schedule 3, Part 7, clause 7.5 |
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
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 - procedure pack or system (rtf,55kb)
Declaration made under Clause 7.5 of Schedule 3 of the Australian Therapeutic Goods (Medical Devices) Regulations 2002
Content last updated: Tuesday, 5 February 2013
Content last reviewed: Tuesday, 5 February 2013
Web page last updated: Tuesday, 26 February 2013
URL: http://www.tga.gov.au/industry/devices-forms-declaration-conformity.htm