Fact Sheet: Operation of the reciprocal arrangement between the TGA and HPFB on manufacturers of medical devices

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Contact: Bureau of Policy, Science and International Programs Enquiries

What does the Memorandum of Understanding (MoU) achieve?

The MoU establishes a reciprocal arrangement between TGA and HPFB whereby manufacturers of medical devices in Australia, New Zealand and Canada may export their products without needing to undergo duplicate assessments of their quality management systems (QMS).

What is the scope of the HPFB-TGA MoU?

The MoU includes all medical devices:

1. that meet the definition of a medical device in both Canada and Australia;
2. that, if destined for Australia, are either licensed for sale in Canada or are the subject of an application made by the manufacturer to obtain a medical device licence for the sale in Canada;
3. that, if destined for Canada, are either included in the Australian Register of Therapeutic Goods (ARTG) or are the subject of an application made by the manufacturer for assessment by the TGA, for inclusion in the ARTG;
4. that have comparable QMS requirements; and
5. for which the manufacturer resides in Canada, Australia or New Zealand.

Are there additional requirements for manufacturers that hold Certificates issued by the TGA under the terms of the MoU?

QMS Certificates issued by the TGA to Australian or New Zealand manufacturers will be recognised by the HPFB, Health Canada, and taken into consideration as part of an application for a device licence that would allow supply in Canada. Certificates are issued for quality systems only.

Australian or New Zealand manufacturers that wish to sell medical devices in Canada must also meet the Canadian product requirements relating to medical devices. These requirements can be found on the Health Canada website.

Can QMS Certificates issued by Registrars under the MoU be used in place of TGA Conformity Assessment Certificates in Australia?

No, TGA Conformity Assessment Certificates involve both quality system and product assessment, the MoU covers only quality systems.

QMS Certificates issued by a participating Registrar will be recognised by the TGA and taken into consideration in connection with an application for a Conformity Assessment Certificate issued by the TGA.

How can Australian and New Zealand manufacturers make use of the MoU for export to Canada?

Under the MoU, Australian and New Zealand manufacturers of medical devices may apply for simultaneous assessment by the TGA of their quality systems to Australian and Canadian requirements.

This removes the previous requirement for duplicate assessments of a manufacturer's quality management system by both the TGA and by a Health Canada recognised Registrar¹.

How can Canadian manufacturers make use of the MoU for export to Australia?

QMS Certificates issued by a participating Registrar will be recognised by the TGA. More information on participating Registrars is below.

Where a Conformity Assessment Certificate, issued by the TGA, is required, the TGA will consider these QMS Certificates in connection with the application.

How can Registrars participate under the terms of the MoU?

Registrars can apply to be recognised by the TGA, which would allow them to issue MoU Certificates to eligible Canadian manufacturers. The TGA will undertake an assessment of the Registrar's ability to audit to Australian requirements. This will involve a desk-top assessment of the Registrar's systems, observed audit(s), and training of the Registrar's designated auditors, which is examinable.

Expressions of interest should be directed to:

Head,
Office of Devices Authorisation
Therapeutic Goods Administration
Post Office Box 100, WODEN, ACT, AUSTRALIA
Email: devices@tga.gov.au

How can Canadian manufacturers exporting to Australia apply for a QMS Certificate issued under the terms of the MoU?

Canadian manufacturers must select a Registrar that has been recognised by the TGA to conduct QMS audits that meet Australian requirements. Information on TGA recognised Registrars may be obtained by contacting devices@tga.gov.au.

How can Australian and New Zealand manufacturers apply for a QMS Certificate issued under the terms of the MoU?

Manufacturers can apply for a QMS Certificate by including 'HC MoU' in the description field of the electronic form when submitting a Conformity Assessment application to the TGA's online e-Business system.

Do suppliers to an Australian or Canadian manufacturer need to reside in Australia or Canada to be eligible under the MoU?

Suppliers to an Australian or Canadian manufacturer do not need to reside in Australia or Canada. The medical device manufacturer must reside in the country of origin.

¹ Canada's Quality System Requirements