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After your system or procedure pack is on the market, you have ongoing responsibilities.
You must:
maintain your product’s inclusion in the Australian Register of Therapeutic Goods
pay ongoing regulatory charges
get approval for variations to your product
monitor your pack’s safety
report adverse events
cooperate with post-market surveillance activities.
We monitor products to ensure they continue to meet safety, quality, and performance standards.
Meeting these responsibilities helps protect patients, maintain compliance, and support confidence in your product.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.