Before a new medical device can be supplied to the market in Australia it needs to be assessed by the TGA (Therapeutic Goods Administration). The TGA’s regulatory requirements vary, depending on what the device is and how it is to be used.
• are used on humans
• have therapeutic benefits
• generally have a physical or mechanical effect on the body or are used to measure or monitor functions of the body.
Medical devices range from a bandage that you would put on a scratch to high risk products such as pacemakers that are implanted in your body. Examples of medical devices include:
• artificial hips
• blood pressure monitors
• breast implants
• lubricating eyedrops
• MRI scanners
• Orthodontics – eg braces, fillings
Software is increasingly being used both as a medical device and in medical devices. Unless ‘excluded’ or ‘exempt’, software-based medical devices are required to be included in the Australian Register for Therapeutic Goods (ARTG) prior to supply. Further information can be found at Software as a Medical Device.
In order for the TGA to maintain public confidence in the safety, performance, benefits and risks associated with the use of medical devices on the Australian market, assessments may be conducted:
• before a device is able to be supplied to the market in Australia, and
• while a medical device is available on the market.
The TGA’s regulatory requirements vary, depending on what the device is and how it is to be used. The TGA is involved in most of the stages in the life cycle of a medical device. The team at DTS can assist in determining whether a product requires registration. Alternatively it may be possible to modify the product claims to overcome the need for registration.
Medical Device Registration – New Zealand
Pre-market approval of medical devices is not necessary in New Zealand, however market entry does require listing your product in MedSafe’s Web Assisted Notification of Devices (WAND) database within 30 days of commercialization. Before your device is listed in WAND, you must ensure you have documentation that proves your device’s safety and effectiveness (such as certification from an EU Notified Body, Health Canada or US FDA) because MedSafe may request such information.
For medical devices to be legally supplied in New Zealand they must be notified to the WAND database. Notification of medical device information to the WAND database is free and there are no on-going fees. Devices must be notified to the WAND database within 30 calendar days of a person or organisation becoming the sponsor of the device.
This Regulation requires the following information to be entered into the database;
- The risk classification of the device (as determined in Schedule 2 of the Regulations)
- The address of the registered office or principal place of business in New Zealand of the sponsor
- A contact telephone number or email address for the sponsor
- The address of the registered office or principal place of business of the manufacturer (whether in New Zealand or overseas)
- A contact telephone number or email address for the manufacturer
- The product description attributed to the device by the Global Medical Device Nomenclature (GMDN) system
Medical devices are rated by their potential risk from Class I (low) to Active Implantable Medical Device (AIMD, high). The Regulations require a sponsor to determine the correct risk classification of its medical devices
Companies that do not have a physical presence in New Zealand must appoint a Sponsor to list a device in WAND. The New Zealand Sponsor maintains responsibility for the accuracy of the information in WAND and is the sole liaison to Medsafe. Similar to the Australian regulatory system, the New Zealand system places vigilance responsibility on the New Zealand Sponsor.