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Regulatory requirements for in-house IVDs

Version 2.2, September 2018

11 September 2018

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Exemptions for in-house IVDs

Therapeutic goods legislation provides exemptions for IVDs that are used for evaluation or experimental purposes, or to deal with emergencies.

Exemptions for experimental purposes

Schedule 4 Part 2 of the MD Regulations sets out the provisions for exempting medical devices for experimental purposes.

Laboratories that need access to an unapproved commercially supplied IVD, or need to develop a Class 4 in-house IVD for experimental purposes, should contact us to discuss the requirement for an exemption.

Exemptions to deal with emergencies

Part 4-6A of the Act allows for certain therapeutic goods be stockpiled to deal with possible future emergencies, or made available urgently to deal with actual emergencies.

For example, Class 4 in-house IVDs that have been developed by laboratories to detect an emerging infectious disease may be exempted from the need to be included on the ARTG in the national interest, to deal with a possible emergency.

Laboratories that manufacture in-house IVDs for these purposes should contact us to discuss the requirement for an exemption.

This type of exemption can only be initiated by the Government (i.e., not by an individual laboratory) in the event of an actual public health emergency or potential emergency.

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