Continued supply of registered and listed therapeutic devices after October 2007

4 October 2007 marks the conclusion of the 5 year period for sponsors of registered and listed therapeutic devices to transition their products to inclusions as Class I, IIa, IIb, III medical devices and Active Implantable Medical Devices under the GHTF framework introduced in 2002. Continued legal supply can only occur if the transitions have been effected by this date.

To enable ongoing supply sponsors must submit applications to the TGA to have these products assessed for compliance under Part 4 of the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002; and entered on the Australian Register of Therapeutic Goods (ARTG) as included medical devices.

There are currently approximately 16,000 therapeutic devices on the ARTG that potentially require applications to be submitted for assessment. It is therefore essential that companies submit applications as soon as possible.

There are a number of guidance documents <http://www.tga.gov.au/devices/devices.htm> available to assist you to understand the regulatory requirements, and the TGA is operating a telephone information service on 1800 141 144.

Alternatively you may wish to seek the services of a regulatory affairs consultant <http://www.tga.gov.au/docs/html/regafair.htm> to assist you with the process.

Australia-Canada MOU

MOU negotiations between the Canadian Health Products and Food Branch (HPFB) and the Australian Therapeutic Goods Administration (TGA) on the reciprocal recognition of quality management system (QMS) certifications for medical device manufacturers are now entering the confidence building phase.

A rigorous confidence building framework has been developed that includes, but is not limited to a review of documentation and audits of each others processes, procedures and systems for conducting audits of manufacturers quality management systems. The confidence building exercise will also include observed on-site audits of medical device manufacturers.

Due to operational considerations, the timelines for the MOU have been revised. The confidence building phase of the project (with the exception of the observed audits), is scheduled to be completed by the end of the first quarter of 2007, after which the TGA and HPFB expect to be able to sign the MOU and receive applications from manufacturers to participate in observed audits.

Under the MOU, QMS Certifications issued by the Manufacturers Assessment Branch of the TGA will be recognized by HPFB and taken into consideration as part of an application for a device licence that would allow supply in Canada. Likewise, QMS certifications issued by a participating Canadian Registrar will be recognized by the TGA and taken into consideration as part of an application for a Conformity Assessment Certificate issued by the TGA. Subsequently, an Australian Sponsor may apply for an inclusion in the Australian Register of Therapeutic Goods to allow supply in Australia.

Once operational, this arrangement will eliminate the necessity for the duplication of QMS audits currently required for manufacturers who export their medical devices to the two jurisdictions.

Further progress reports will be made available at appropriate intervals.

Conformity assessment certificates

A Conformity Assessment Certificate is a certificate some manufacturers need to obtain from the TGA before a medical device can be included in the Australian Register of Therapeutic Goods (ARTG). Conformity Assessment Certificates are issued to manufacturers, not to sponsors.

A document is available outlining how to apply for a conformity assessment certificate and/or an EC certificate of conformity under the EU-Australia MRA <http://www.tga.gov.au/docs/html/devguid26.htm>.