Introduction
A medicinal substance in a medical device must meet Australian manufacturing and quality control requirements.
This stems from Essential Principle 7.4 (Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002) and subsection 25(1)(g) of the Therapeutic Goods Act 1989.
Sponsors of medical devices with medicinal substances can apply to include the device on the register using EU certification. Sponsors with other kinds of overseas approval, or no overseas approval can apply for a TGA conformity assessment certificate.
What has changed?
We used to require sponsors to obtain a Good Manufacturing Practice (GMP) Clearance for overseas manufacturers producing medicinal substances to be incorporated into medical devices. However, this is no longer necessary.
We conducted an internal review of medical devices that incorporate medicinal substances and concluded that we can rely on EU certification and do not need to verify manufacturing and quality control procedures for the medicinal substance. The only exception is the very rare case when the medicinal substance is not regulated as a medicine in the EU (e.g. medicinal cannabis is a medicinal substance in Australia but not in the EU). You are strongly encouraged to email us at devices@tga.gov.au if this situation arises.
What this means
- We will not verify the manufacturing and quality control procedures of the manufacturer of the medicinal substances incorporated into medical devices with appropriate EU medical device certification.
- We will verify the manufacturing and quality control procedures for manufacturers of medicinal substances incorporated into medical devices that are not supported by EU medical device certification. This will be performed as part of an application for a TGA conformity assessment certificate, and we will request the required supporting documentation at that time.
- Medical device sponsors do not need to apply to us for separate GMP clearance and do not need to maintain any existing GMP clearances unless they support a medicinal product on the ARTG.