Australia Medical Device Registration

Regulatory Authority

Australian Therapeutic Goods Administration (TGA)

The TGA is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods. As part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods.

Link for Regulatory Authority

https://www.tga.gov.au/medical-devices-ivds

Local Regulation

• Therapeutic Goods (Medical Devices) Regulations 2002 (https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd )
• Therapeutic Goods Regulations 1990
• Therapeutic Goods Act 1989

Classification of Medical Devices

• Class I – sterile or measuring function
• Class I – other (excluding export only devices)
• Class IIa
• Class IIb
• Class III

Listing or Registration Requirements

• A sponsor of a medical device must apply to the TGA to include their device on the Australian Register of Therapeutic Goods (ARTG).For very low risk devices, a sponsor can self-certify that their product meets the Essential Principles.
• A Manufacturer Evidence application is not required for Class I non-sterile, non-measuring medical devices.
• For Class I non-sterile, non-measuring devices, one must submit the manufacturer’s Declaration of Conformity with application for inclusion in the ARTG.
• A formal application is required for inclusion in the ARTG (Australian Register for therapeutic goods)an independent body must thoroughly assess the device and provide documents to show that the device meets the Essential Principles.
• If the device is a high-risk device (Class III or an Active Implantable Medical Device) the application must be selected for audit.
  The TGA will review the application and assess the device for safety, efficacy, and quality. Pay the applicable fee.

Documents Required for Australia Medical Device Registration

• Manufacturer Evidence for Medical Devices: This is submitted before applying and demonstrates the manufacturer’s quality management system.
• Conformity Assessment Document: This document shows the device meets Australian regulatory requirements. It could be a TGA certificate, overseas approval evidence, or a declaration of conformity.
• Declaration of Conformity (DoC): This is a manufacturer’s statement that the device complies with Australian regulations.
• Product Information: This includes labelling, instructions for use, and information about the device’s purpose and unique identifier.
• Clinical Evidence (for most devices): This shows the device meets essential safety and performance standards.
• Link for more details

Registration Timeline

• Class I sterile or measuring function – 4 weeks
• Class I other (excluding export only devices) – Same Day
• Class IIa – 4 weeks
• Class IIb – 6 weeks
• Class III – 6 months (including application audit)

Registration Fee

Fees and Charges Summary

License Validity

Annual fees need to be paid to keep validity

License Renewal

3 Months before expiry date

Special Labelling Requirements

Labelling should be in English. The Sponsor’s name and information must be included in the labelling.

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk