Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019

This Order constitutes an optional conformity assessment standard for specified quality management systems relating to the manufacture of medical devices.

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Meeting 3-D printing (additive manufacturing) rules for medical devices

23 September 2024

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Guidance for manufacturers to assist them with managing 3-D printing risks and meeting the Australian regulatory requirements for medical devices.

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Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019

Official version of legislation

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Meeting 3-D printing (additive manufacturing) rules for medical devices

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Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019

Official version of legislation

Guidance referring to this legislation

Meeting 3-D printing (additive manufacturing) rules for medical devices

Help us improve the Therapeutic Goods Administration site