EMERGO SUMMARY OF KEY POINTS:

• The Australian TGA has published more detailed guidance on clinical evidence requirements for medical devices and IVD products.
• TGA clinical evidence requirements are based on GHTF standards and European MEDDEV documents.
• Australian regulators may demand clinical evidence from medical device and IVD registrants at any time, not just during premarket review.

Medical device regulators at the Australian Therapeutic Goods Administration (TGA) have published new guidelines explaining what constitutes acceptable clinical evidence for medical device and IVD manufacturers.

The guidelines also cover acceptable processes and procedures for gathering, analyzing and recording such evidence; all medical devices and IVDs registered with the TGA must have adequate clinical evidence to demonstrate safety and performance, and manufacturers must be able to provide clinical evidence to Australian regulators at any time.

More detailed TGA requirements for clinical evidence

According to an Emergo analysis, the new guidelines hew closely to standards established by the Global Harmonization Task Force (GHTF) as well as the European Commission’s MEDDEV guidance documents. Through the guidelines, the TGA has provided a more detailed and thorough overview of TGA expectations and requirements regarding clinical evidence. Specific guidance for some device types such as joint prostheses is also included in the new document.

Previously, TGA registrants could only reference a short section of the Australian Regulatory Guidelines for Medical Devices (ARGMD) for information on clinical evidence requirements.

Emergo Resources and services for the Australian market:

• Australian TGA medical device registration support
• TGA IVD registration support
• Clinical research consulting for Australia
• Whitepaper: Medical device registration in Australia and New Zealand