Call for Comment: Registration of Oil-Free Compressors for Medical Breathing Air

We’re seeking insights and feedback from industry experts regarding an important regulatory question:

Do oil-free compressors purchased by third parties for hospital medical breathing air purposes need to be registered with the Australian Register of Therapeutic Goods (ARTG)?

Some key context:

• The compressors in question are not specifically marketed, designed, labeled, or presented for medical breathing air purposes.

• Despite this, these compressors are occasionally purchased by third parties for hospital or clinical use.

• The ARTG has been contacted and their response has been positive, referring to Section 41BD of the Therapeutic Goods Act 1989.

We are looking to gather perspectives on:

• Whether manufacturers in this scenario have any obligations to register their compressors with the ARTG, even if the products are not intended for therapeutic use.

• How hospitals and other end-users should navigate regulatory compliance when using non-medical compressors for breathing air purposes.

• Any practical guidance or precedent in this area.

If you have experience or expertise in medical device regulation, therapeutic goods compliance, or hospital equipment procurement, your input would be highly valuable.

Please share your comments or contact us directly — your insights will help clarify the regulatory landscape and support safe, compliant practices in healthcare settings.

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