Market access in Australia - TGR certification
Therapeutic Goods Regulations (TGR) of Australia
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.
How can BSI help you obtain a conformity assessment certificate?
Our team of experts has extensive conformity assessment experience in the EU and other global markets, and we are committed to acting as your partner during the review process. Any challenges during conformity assessment are faced with one goal in mind: getting your product to market efficiently. An overview of the process consists of:
- BSI conducts a comprehensive review of your documentation, ensuring device(s) demonstrate compliance with TGR Essential Principles (similar to the European Essential Requirements) and TGR Conformity Assessment Procedures (also similar to EU standards)
- Following successful completion of the review, BSI will issue a Conformity Assessment Certificate (under the EU-Australian MRA) for the device’s quality system and design examination
- Conformity Assessment Certificates under this MRA are valid for a period of five years after which time the certification will be reviewed. With a compliant follow-up review, the certificates will be reissued for another five-year period
Depending on the manufacturer, there are a few ways we can assist in the certification process:
- For existing EC clients, our conformity assessments will help you achieve TGR compliance quickly and efficiently
- For clients seeking EC certification plus Australian approval, we can provide conformity assessments that help you achieve market readiness in both the EU and Australia
- For countries outside the EU member states, we cannot offer conformity assessments for TGR compliance, but we can provide evidence (through assessment reports and certificates) that the Australian government can consider in their evaluations
Partnering with us in the conformity assessment process is especially beneficial for manufacturers taking high-risk devices into the Australian market.
Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include: