Road to registering your medical device in Australia

Road to registering your medical device in Australia
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In Australia the Therapeutic Goods Administration (TGA) overseas the medical devices which are placed on the market. The TGA enforces the Therapeutic Goods (Medical Devices) Regulations 2002 as amended. Guidelines to the Regulations can be found at Australian Regulatory Guidelines for Medical Devices (ARGMD).

Pre-market:

  1. Determine if your product is a medical device?

Does your product meet the definition of a medical device, whereby the product is intended to be used on humans for any of the following;

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability
  • Investigation, replacement or modification of the anatomy or of a physical process
  • Control of contraception.

The product is also considered a medical device if used as an accessory to any product described above.

  1. Determine the classification of the device per the ARGMD. If the device is CE marked, the classification is the same (Note, there are a few exceptions to this.).
    1. Class I medical devices that do not have a measuring function and are not intended to be supplied sterile are self-certified. This means they can be ‘auto included’ in the ARTG. The sponsor must provide a copy of declaration of conformity by the manufacturer and submit an electronic application.
  2. Implement a Quality Management System.
  3. For CE marked devices; A CE mark certificate from a notified body is generally accepted by the TGA. In addition, the TGA accepts MDSAP certificates and overseas marketing approval of the countries that are part of the MDSAP program. Have a copy of the technical file or design dossier and an Australian Declaration of confirmatory, available for review by the TGA.
  4. For products that do not have the CE mark or other market authorisation evidence from comparable overseas regulators; manufacturers must obtain a TGA Conformity Assessment Evidence (not applicable to Class I devices) including demonstrating compliance with the essential principles; these outline the fundamental design and manufacturing requirements for medical devices. The appropriate conformity assessment procedure must be applied to ensure the devices compliance. There are 6 general Essential principles which apply to all devices and another 9, which are applied based on the device type.
  5. Applicant must provide a copy of the conformity assessment certificate issued to the manufacturer by an appropriate conformity assessment body or Manufacturer’s declaration of conformity.
  6. If you don’t have an Australian presence, appoint an Australian sponsor, the sponsor must be based in Australia and will be the manufacturer’s representative with the TGA.
  7. TGA reviews the application in the TBS (TGA Business services system), for inclusion in the ARTG.

Post market:

  1. Manufacturers must continue to monitor the performance and safety of their devices and ensure continued compliance with the Essential Principles.
  2. Ensure an appropriate post market surveillance and feedback process is in place.

If you are planning or in the process of registering your medical device to the Australian market and would like more information, contact KD&A kdent@kdas.com.au

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