HOW TO OBTAIN MEDICAL DEVICE APPROVAL IN AUSTRALIA
Regulations
The current regulations are the Australian Therapeutic Goods (Medical Devices) Regulations 2002. They are supported by several legislative standards orders covering animal tissue, sterilization and risk management. The regulatory authority is the Therapeutic Goods Administration (TGA) and they are also the conformity assessment body for Australian manufacturers and some foreign sites. The Australian regulations were based on EU directive 93/42/EEC and with a few exceptions can be considered equivalent.
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Scope and Classification of Devices
The regulations cover medical devices but not IVDs and classification is based on the European system of Class I, IIa, IIb ,III and Active Implantable Medical Devices (which are considered Class III) Classification rules are not always identical to 93/42/EEC.
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Technical Documentation
Technical documentation showing compliance to the Essential Principles of the regulations is required. Clinical evidence and risk management play a very important role in this documentation. The regulations make certain standards such as ISO 11135 and ISO 11137 effectively mandatory. When assessment of technical documentation is required as part of the pre-market assessment, it is undertaken by the TGA or by an EU Notified Body approved by the TGA.
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Quality Systems
The standard for quality management systems is ISO 13485:2003 and a QMS audit is required for manufacturers of all classes except Class I (not sterile or without a measuring function). The QMS audit will either be by a Notified Body as part of the CE mark certification or by the TGA. Australian manufacturers must use the TGA for Australian registration.
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Local Distributors, Licenses and Registration
Foreign manufacturers must have an Australian sponsor and the sponsor takes certain regulatory responsibilities and applies for registration on the Australian Register of Therapeutic Goods (ARTG). Following registration, devices can be placed on the market. It should be noted that GMDN terms are required for Australian registration.
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Future Developments
The past few years have seen several draft changes in the regulations, including the possibility of a combined Australia/New Zealand regulatory authority. A combined authority is unlikely now, but other significant changes are expected.
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SGS Certification
SGS United Kingdom is approved by the TGA under the EU/Australia Mutual Recognition Agreement and can issue certification under that agreement to manufacturers located in Europe via the SGS European medical device offices. Manufacturers outside Europe can use SGS CE mark and ISO 13485:2003 certification to gain registration for low/medium risk devices but will require an additional TGA assessment for high risk devices.
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SGS Training
SGS offers in house training on the Australian regulations and the changes needed to the quality system and technical documentation to ensure compliance. Gap analysis audits can also be undertaken.
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Contact SGS
Advice on Australian Medical Device Regulations and certification is available from SGS medical devices offices.
This summary should not be taken as a definitive description of the requirements as regulations and interpretations do change and this is intended to be an outline only. Manufacturers must verify the requirements that apply to them before proceeding.
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