Australia Therapeutic Goods (Medical Devices) Regulations 2002
Part 4 and Part 4A: conformity assessment certificates and Australian conformity assessment bodies – Australia Therapeutic Goods (Medical Devices) Regulations 2002

Australia Therapeutic Goods (Medical Devices) Regulations 2002 r4.6-4.11: Keep the certificate holder accurate: notify the Secretary within 3 months of the manufacturer's death, bankruptcy, winding up or change of name, apply within 3 months to change the name after a business disposal or amalgamation, give documentary evidence, and return superseded certificates

What does r4.6-4.11 require?

Where a manufacturer holding a conformity assessment certificate dies, goes bankrupt or (as a company) is wound up, the legal personal representative, trustee or liquidator steps into its place and must notify the Secretary in writing within 3 months. Where the business making the device is sold with the certificate, or the company amalgamates under a different name, the buyer or amalgamated company becomes the holder and must apply in writing within 3 months to have the name changed. A manufacturer that changes its name must notify the new name and circumstances within 3 months. Every notification must come with documentary evidence; if the Secretary learns an event was not notified, the certificate may be suspended or revoked. When the Secretary changes the name on, suspends or revokes a certificate, the manufacturer must return the old certificate as soon as practicable (a strict liability offence, 5 penalty units). A certificate covering a device containing a scheduled poison carries the automatic condition that the manufacturer will not supply it in breach of Part 2 of the Poisons Standard (regulation 4.3G).

Maintained by Gerard Blokdyk

Other controls in Part 4 and Part 4A: conformity assessment certificates and Australian conformity assessment bodies – Australia Therapeutic Goods (Medical Devices) Regulations 2002

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