TGA conformity assessment certificate procedures
Historically, the Australian TGA and EU notified bodies have performed conformity assessments of manufacturers technical documentation against each other’s regulatory requirements under the Mutual Recognition Agreement (MRA).
However, the MRA was updated on 1 January 2013 to exclude a number of device categories, including Active Implantable Medical Devices (AIMDs) and Class III devices, implantable intra-ocular lenses and intra-ocular visco-elastic fluids, and barrier devices indicated for contraception or the prevention of sexually transmitted disease. Other exclusions include some specific combination products with medicines or biologicals. The Amending Act also details a redefinition of “manufacturing”, and an extension to scope to include lower risk classes of radioactive medical devices. For more information on the changes implemented in the Amending Agreement, see our eNews update.
Both the TGA and EU remain in discussion during this confidence building stage, to ensure that the conformity assessment bodies engaging in reviews are capable and competent.
How does this affect my certificate?
Certificates issued by a European notified body under the MRA before 1st January, 2013,will remain valid until the date of expiry, or January 2018, whichever is earlier.
Australia and the Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit to meet the QMS/GMP requirements of multiple Regulatory Authorities (RAs).
The Australian Therapeutic Goods Administration (TGA) is a participating RA, having completed the three year pilot phase of the Program, which ended in December 2016. The TGA will use an MDSAP audit report as part of the evidence that is assessed for compliance with medical device market authorization requirements unless the medical device is otherwise excluded or exempt from these requirements or if current policies restrict the use of MDSAP audit reports.
MDSAP audits are conducted by recognized Auditing Organizations (AOs); BSI is a recognized AO and participated in the Program's pilot phase.
Find out more about the Program, who is involved and BSI's role now.