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Manufacturers of Class 1 medical devices

Fact sheet no. 21

October 2006

1. Key steps for a manufacturer

The key steps to be completed by a manufacture of a Class I medical device are:

  • Classify the medical device,
  • Apply an appropriate conformity assessment procedure,
  • Apply the applicable essential principles and document the technical information showing compliance including risk management activities and clinical evidence,
  • If the medical device is supplied sterile or has a measuring function, a Conformity Assessment Certificate is required;
    • for Australian manufacturers a Certificate of Conformity as referred to in Chapter 4, Part 4.4 of the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002, or
    • for overseas manufacturers a TGA recognised overseas equivalent, and
  • Complete an Australian Declaration of Conformity.

2. Classifying medical devices

The manufacturer classifies the device by applying the classification rules.

For further help please refer to the guidance document Classification of Medical Devices and the Therapeutic Goods (Medical Devices) Regulations 2002, Part 3, Division 3.1 and Schedule 2.

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3. Conformity assessment procedures

The obligations imposed on manufacturers are known as Conformity Assessment Procedures (CAPs). The CAPs for most Class I devices are in Part 6, Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).

Class I devices supplied sterile must also undergo production quality assurance procedures (Part 4, Schedule 3 of the Regulations).

Class 1 devices with a measuring function must also undergo:

  • Verification procedures (Part 3, Schedule 3 of the Regulations) or
  • Production quality assurance procedures (Part 4, Schedule 3 of the Regulations) or
  • Product quality management system procedures (Schedule 3, Part 5 of the Regulations).

For further help please refer to the guidance document Conformity Assessment Procedures <http://www.tga.gov.au/docs/html/devguid3.htm>.

4. Technical documentation

The technical documentation required for a Class I medical device include:

  • A description of the medical device,
  • Diagrams or drawings of its design and any components or sub-assemblies,
  • Descriptions or explanations of the diagrams,
  • The method of sterilisation (if applicable),
  • The standards applied or solutions to ensure compliance with the essential principles,
  • The results of any calculations, risk analyses, investigations, or other tests carried out,
  • Evidence that the device will comply with the essential principles when connected to the other device (if applicable),
  • The information that will accompany the medical device, and
  • Clinical evidence for the device.

Information on the technical documentation is in Part 6, Schedule 3 of the Regulations.

5. Essential principles

The essential principles of safety and performance that apply to all medical devices are in Schedule 1 of the Regulations. A checklist for the essential principles is available <http://www.tga.gov.au/devices/epcheck.htm>.

6. Clinical evidence

Clinical evidence is required for all medical devices. The evidence should be appropriate to the nature of the device, its intended use and the risks associated with its use.

For further help please refer to the guidance document "Clinical evidence requirements for inclusion of medical devices in the Australian Register of Therapeutic Goods" <http://www.tga.gov.au/docs/html/devguid4.htm>.

7. Declaration of conformity

The manufacturer of a medical device is required to make a declaration that the medical device complies with:

  • the applicable essential principles
  • the classification rules and
  • the conformity assessment procedures.

For further help please refer to the guidance document "Declaration of Conformity".

Disclaimer

This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.

Further information

The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the Therapeutic Goods Administration (TGA) can be contacted by:

Telephone: 1800 141 144
Facsimile: 02 6232 8299
Email:
Website: http://www.tga.gov.au/devices/devices.htm
Mail: PO Box 100, Woden ACT 2606

© Commonwealth of Australia 2006

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