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.