Australia Market Access
The Mutual Recognition Agreement (MRA) between Australia and the European Union (EU)
Signed in 1998 and effective since 1999, the Mutual Recognition Agreement (MRA) between Australia and the European Union (EU) recognises the competence of designated conformity assessment bodies (CABs) located in the EU to assess compliance of certain types of medical devices with Australia’s regulatory requirements. Conversely, the MRA also recognises the competence of the Australia’s Therapeutic Goods Administration (TGA) to assess medical devices for compliance with EU requirements.
As of January 1, 2013, the EU/Australian MRA has been amended to exclude some medical devices from the scope of the Agreement. Medical devices now excluded from the MRA are active implantable devices, Class III medical devices, implantable intra-ocular lenses, intra-ocular visco-elastic fluids and contraceptive devices (medical devices that are a barrier indicated for contraception or prevention of the sexual transmission of disease). The exclusion of these medical devices will continue until confidence building activities have been undertaken by Australia and the European Union. Certain additional medical devices incorporating materials of biological origin are also principally excluded, with no confidence building phase.
Other changes include a specific clause that specifies the term “manufacturing” and describes what is not considered to be “manufacturing”. The scope of the MRA has also been extended by including radioactive medical devices of lower risk classes.
Medical devices still covered under the terms of the amended MRA that have undergone a conformity assessment procedure according to Australian Medical Device Regulations are included by TGA on the Australian Register of Therapeutic Goods (ARTG) without delay. To achieve ARTG listing, the manufacturer’s Australian sponsor must submit to the TGA the required device application form, along with copies of the product labelling, an Australian Declaration of Conformity, a copy of the EC and ISO certificates and the MRA certificate. By applying the MRA for medical device registration, there is no audit carried out by the TGA, no additional assessment of the technical file, no consultation with the national health authority and therefore no extra charges.
Nevertheless, for companies that do not apply the MRA between Australia and the EU, a complete registration process must be carried out. Although the TGA’s regulations and approval process are generally similar to those applicable in the EU, the full TGA registration process can take from two to twelve months to complete, depending on the degree of risk associated with the device, and whether the TGA determines that an audit is required.
TÜV SÜD is an authorised CAB under the EU/Australian MRA, and is the world’s largest Notified Body for medical devices in the EU. In addition, TÜV SÜD’s global network provides an effective single source of expertise in the testing and certification of medical devices to EU requirements, as well other major markets.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971 and conduct thousands of in-depth risk management audits each year.
- GLP-compliant biocompatibility testing and biological evaluation - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
- Oher testing and certification services - TÜV SÜD Product Service can conduct compliance testing for medical devices in accordance with other relevant regulations and standards, including IEC 60601-1 and electromagnetic compatibility (EMC).
As of January 1, 2013, the EU/Australian MRA has been amended to exclude some medical devices from the scope of the Agreement. Medical devices now excluded from the MRA are active implantable devices, Class III medical devices, implantable intra-ocular lenses, intra-ocular visco-elastic fluids and contraceptive devices (medical devices that are a barrier indicated for contraception or prevention of the sexual transmission of disease). The exclusion of these medical devices will continue until confidence building activities have been undertaken by Australia and the European Union. Certain additional medical devices incorporating materials of biological origin are also principally excluded, with no confidence building phase.
Other changes include a specific clause that specifies the term “manufacturing” and describes what is not considered to be “manufacturing”. The scope of the MRA has also been extended by including radioactive medical devices of lower risk classes.
Medical devices still covered under the terms of the amended MRA that have undergone a conformity assessment procedure according to Australian Medical Device Regulations are included by TGA on the Australian Register of Therapeutic Goods (ARTG) without delay. To achieve ARTG listing, the manufacturer’s Australian sponsor must submit to the TGA the required device application form, along with copies of the product labelling, an Australian Declaration of Conformity, a copy of the EC and ISO certificates and the MRA certificate. By applying the MRA for medical device registration, there is no audit carried out by the TGA, no additional assessment of the technical file, no consultation with the national health authority and therefore no extra charges.
Nevertheless, for companies that do not apply the MRA between Australia and the EU, a complete registration process must be carried out. Although the TGA’s regulations and approval process are generally similar to those applicable in the EU, the full TGA registration process can take from two to twelve months to complete, depending on the degree of risk associated with the device, and whether the TGA determines that an audit is required.
TÜV SÜD is an authorised CAB under the EU/Australian MRA, and is the world’s largest Notified Body for medical devices in the EU. In addition, TÜV SÜD’s global network provides an effective single source of expertise in the testing and certification of medical devices to EU requirements, as well other major markets.
- Product safety testing and certification - TÜV SÜD Product Service is an EU Notified Body for medical devices, and is recognised by other regulatory agencies throughout the world for its extensive experience with a broad range of medical devices.
- Risk management expertise - TÜV SÜD experts have extensive experience in every aspect of risk management systems for medical device manufacturers in accordance with ISO 14971 and conduct thousands of in-depth risk management audits each year.
- GLP-compliant biocompatibility testing and biological evaluation - TÜV SÜD laboratories conduct biocompatibility tests in compliance with GLP Principles.
- Oher testing and certification services - TÜV SÜD Product Service can conduct compliance testing for medical devices in accordance with other relevant regulations and standards, including IEC 60601-1 and electromagnetic compatibility (EMC).
Your benefits at a glance
- Recognised medical device expertise - TÜV SÜD Product Service is the largest EU Notified Body in the world. With a Regulatory Foreign Affairs and Clinical Affairs Department, TÜV SÜD is recognised by regulatory authorities for its extensive experience with all types of medical devices.
- Quality system certification and auditing expertise - Medical device approvals routinely require the implementation of a quality management system. TÜV SÜD conducts quality management system certifications, audits and factory inspections consistent with most international regulations and standards, allowing TÜV SÜD clients to enjoy the benefits of coordinated inspections and audits, while reducing downtime and costs.
- Active involvement in standards development and implementation - TÜV SÜD Product Service technical professionals are actively involved in standards development activities related to medical devices, and participate in a number of key standards committees worldwide.
- Single source solution - TÜV SÜD Product Service offers testing services for major medical device markets according to international standards and regulations.
- Regional and local proficiency - Our regional medical health experts speak your local language and understand regional and local regulations and knowledge needs.
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Additional resources
Therapeutic Goods Administration (TGA)
Australian regulatory guidelines for medical devices
Therapeutic Goods Regulations 1990
Therapeutic Goods (Medical Devices) Regulations 2002
Medical device amendments to the EU-Australia MRA on conformity assessment to come into effect 1 January 2013
EU-Australia MRA on Conformity Assessment: Ratification of Medical Device Amendments
Australian Treaty Series