Medical Devices Registration
Medical Device Registration in Australia
Before a medical device can be lawfully supplied in Australia, it must comply with the requirements of the Therapeutic Goods Administration (TGA). The TGA regulates devices under the Therapeutic Goods Act 1989, with requirements that vary depending on the device type, intended purpose, and risk classification.
“Every medical device in Australia must earn its trust.
Compliance with TGA standards ensures safety, quality, and reliability.”
Definition and Scope
Medical devices are products that:
- Are intended for use in humans
- Provide a therapeutic benefit
- Achieve their primary intended action through physical or mechanical means, or by measuring/monitoring bodily functions
Medical devices range from low-risk items such as dressings and bandages to high-risk, implantable, or life-sustaining products. Examples include:
- Artificial hips and implants
- Blood pressure monitors and diagnostic equipment
- Catheters
- Lubricating eye drops
- MRI scanners and imaging equipment
- Orthodontic devices (e.g., braces, fillings)
- Software classified as a medical device (SaMD)
Software as a Medical Device
Software that meets the definition of a medical device, whether standalone or incorporated within hardware-must be included in the Australian Register of Therapeutic Goods (ARTG) prior to supply, unless it falls under an exemption or exclusion.
- Medical Device Registration
- Sustainable Practices
- Seamless ARTG Approval
- Experienced Team
TGA’s Role and Assessment Process
The TGA ensures medical devices are safe, effective, and of acceptable quality by:
- Assessing devices prior to market approval (pre-market assessment)
- Conducting post-market monitoring throughout their supply lifecycle
- Reviewing compliance with risk classification, performance evidence, labelling, and manufacturing standards
Manufacturers and sponsors are responsible for ensuring conformity assessment certification and evidence of compliance. Products must only be supplied once included in the ARTG.
The ANZ regulatory team can assist with TGA submissions, confirm whether registration is required, and advise on product claims that may influence classification and regulatory obligations.
Medical Device Registration in New Zealand
In New Zealand, medical devices are not subject to mandatory pre-market approval. Instead, market entry requires notification to Medsafe’s Web Assisted Notification of Devices (WAND) database within 30 calendar days of supply or sponsorship.
TGA’s Role and Assessment Process
To supply a device legally, the following key information must be lodged in WAND:
- Risk Classification (as set out in Schedule 2 of the Medicines (Database of Medical Devices) Regulations 2003)
- Sponsor details – legal entity with a physical presence in New Zealand, including address and contact information
- Manufacturer details – registered office and production location(s)
- Product description – based on the Global Medical Device Nomenclature (GMDN) system
Notification is free of charge and has no annual fees but must remain up to date for as long as the device is supplied.
Risk Classification
Devices are classified according to risk, ranging from Class I (low-risk) through to Active Implantable Medical Devices (AIMD – high-risk). Sponsors must accurately determine and apply the correct classification upon submission.
Role of the Sponsor
If a company does not have a physical presence in New Zealand, a local Sponsor must be appointed. The Sponsor is legally responsible for:
- Acting as the sole liaison with Medsafe
- Maintaining current and accurate WAND information
- Ensuring post-market vigilance and compliance with applicable requirements
- Providing evidence of international approvals (EU CE marking, US FDA clearance, Health Canada licensing, etc.), if requested by Medsafe