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Overseas - Not a medical device
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It is an offence to manufacture therapeutic goods for human use without a licence unless the product or manufacturer is exempt from this requirement under the Therapeutic Goods Regulations 1990. For overseas manufacturers, the same exemptions apply unless otherwise specified.
Some therapeutic goods are exempt from licensing requirements. Check Schedule 7 of the Therapeutic Goods Regulations 1990 to find out if your therapeutic good is exempt from the manufacturing principles.
Some persons are exempt from licensing requirements. Check Schedule 8 of the Therapeutic Goods Regulations 1990 to find out if the person manufacturing the goods is exempt from the manufacturing principles.
We recommend you seek independent legal advice to ensure you comply with the legislation.
Question
Is the product or manufacturer exempt under the Therapeutic Goods Regulations 1990?