Once your disinfectant or sterilant is on the Australian market, you must keep it safe and compliant.
You need to:
manage your product’s inclusion in the Australian Register of Therapeutic Goods (if relevant), including notifying us of changes
pay any fees
monitor product safety
reporting any product issues.
We monitor products to protect public health and ensure ongoing compliance.
Maintaining product quality and safety is vital. Meeting these responsibilities helps you supply your product lawfully and maintains consumer trust.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to other therapeutic goods (OTG). You may also have to meet obligations that apply to all OTG and all products.
Monitoring and reporting
Find sponsor obligations for ongoing monitoring and reporting.
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PageAs the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events.
Compliance
Learn how we ensure compliance, including post-market reviews.
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PageKnow the ways we respond to breaches such as warnings, fines and legal action.
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PageFind out how we approach and manage compliance with therapeutic goods regulation in Australia.