The Therapeutic Goods Administration (TGA) has released guidelines clarifying the regulatory obligations for exempt medical devices. While these devices do not require inclusion in the Australian Register of Therapeutic Goods (ARTG), sponsors and manufacturers must still adhere to stringent standards to ensure patient safety.
Key Points of the New Guidance
- Ongoing Regulatory Oversight: Despite exemption from ARTG inclusion, exempt medical devices remain under TGA jurisdiction.
- Adverse Event Reporting: Sponsors and manufacturers are required to report adverse events or near misses through the TGA's Incident Reporting and Investigation Scheme (IRIS).
- Recall Procedures: The Uniform Recall Procedure for Therapeutic Goods (URPTG) applies to exempt devices, mandating TGA approval for recall actions.
- Advertising Compliance: Advertisements for exempt medical devices must adhere to the Therapeutic Goods Advertising Code, prohibiting unauthorized claims and requiring approval for restricted representations.
- Conformity Assessment: Manufacturers must maintain evidence demonstrating compliance with Essential Principles and relevant conformity assessment procedures.
- Recordkeeping: Detailed records related to device design, production, and performance must be kept for a minimum of five years after the manufacture of the last medical device.
- Penalties: Non-compliance with these regulations can result in criminal and civil penalties.
Implications for Industry
The guidance reinforces the TGA's commitment to patient safety, even for exempt medical devices. Sponsors and manufacturers must implement robust systems to ensure compliance with reporting, recall, advertising, and conformity requirements. Failure to do so could lead to significant consequences.
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References
For more information on the obligations, kindly refer to Regulatory obligation for exempt medical devices.