ARTG Exemptions for Certain Medical Devices

The Australian Therepeutic Good Administration (ARTG) has announced exemptions for certain medical devices from being included in the ARTG before import, export, or supply. However, these exempt devices must still comply with other regulatory requirements. 

What Are the Key Points for ARTG Exemptions? 

 Adverse Reporting: 

• • Sponsors and manufacturers must report adverse events through the IRIS system via the TGA eBusiness Portal or the medical device incident report form. 

Recall Procedures:  

• • The Uniform Recall Procedure for Therapeutic Goods (URPTG) outlines the standardized process for recalls. Sponsors must notify and get approval from the TGA before proceeding with any recall actions. 

Advertising Compliance:  

• • Advertisements for medical devices must follow the Therapeutic Goods Advertising Code, applicable across all media formats. Unauthorized claims and the term ‘TGA approved’ are prohibited unless specifically authorized. 

Conformity Assessment Procedures:  

• • Manufacturers must maintain evidence of conformity with the Essential Principles. This includes holding an Australian Declaration of Conformity for some Class I devices. 

Record Keeping:  

• • Manufacturers must keep technical documentation and other relevant records for at least five years post-manufacture. Changes or issues must be reported to the Australian sponsor and the TGA. 

Failure to comply with these ongoing responsibilities can result in criminal and civil penalties. For a detailed list of exempt medical devices, refer to Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002 here. 

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If you need assistance determining if your medical device is affected by the ARTG exemptions, contact us, so we can help you. 

Learn how MedEnvoy can assist you:

• • Australian TGA Sponsor
  • RA Consulting
  • QA Consulting