Medical Device Regulatory Compliance Consulting

The supply of medical devices in Australia is governed by the Therapeutic Goods Act and Regulations. Medical Devices supplied commercially must generally be included on the Australian Register of Therapeutic Goods (ARTG). Other countries have similar requirements.

What is a medical device?

From the Therapeutic Goods Act 1989, section 41BD
A medical device is:

1. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
   
   1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
   2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
   3. investigation, replacement or modification of the anatomy or of a physiological process;
   4. control of conception;
   5. and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means;

   or

   1. any instrument, apparatus, appliance, material or other article specified under subsection (2A);
   or
   2. any instrument, apparatus, appliance, material or other article that is included in a class of instruments, apparatus, appliances, materials or other articles specified under subsection (2B);
   or
2. an accessory to such an instrument,apparatus, appliance, material or other article covered by paragraph (A), (Aa) or (Ab).

When something is deemed to be a medical device, the manufacturer and supplier become responsible for determining the class of medical device as well as ensuring that it complies with all the requirements of the Therapeutic Goods Act and Regulations. From several decades of experience with researching, developing, maintaining and managing biomedical equipment, SA BME has comprehensive working knowledge of the requirements for supplying medical devices, of various classifications, for use in various medical and research applications.

Through FBE, SA BME’s expertise can assist medical device manufacturers with the regulatory compliance process, and the associated documentation.