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Medical Device Registration in Australia
Medical Devices and In-Vitro Diagnostics are overseen by the Therapeutic Goods Administration (TGA), a division of the Australian Government’s Department of Health.
Medical Device Status
Medical devices are defined by section 41BD of the Therapeutic Goods Act 1989 (the Act). The Therapeutic Goods Act 1989 provides the legislative basis for uniform national controls over goods used in the prevention, diagnosis, curing or alleviation of a disease, ailment, defect or injury.
In summary, medical devices:
- Are used for humans;
- Are intended to diagnose, prevent, monitor, treat or alleviate a disease or injury, or modify or monitor anatomy or physiological functions of the body; and
- Generally achieve their purpose by a physical, mechanical or chemical action.
Device Conformity Assessment
Manufacturers seeking ARTG inclusion will need to provide evidence of an acceptable certification from the TGA or other Conformity Assessment Body (CAB), such as a European Notified Body. Conformity assessments require the manufacturer show compliance to the Essential Principles which consists of 6 fundamental requirements and an additional 9 that are applied on a case-by-case basis. Manufacturers without a local office in Australia will need to work with an Australian Sponsor to submit applications, answer questions, and provide post market surveillance support.
Products that have already demonstrated conformity through one of the below routes can utilize their certification as evidence of conformity to the Essential Principles and bypass the full review process, though a Level 1 or Level 2 audit may still be required.
- Certificates issued by Notified Bodies designated by the medical device regulators of European member states;
- Decisions by the United States Food and Drug Administration (FDA);
- Approvals and licenses issued by Health Canada;
- Pre-market approvals from Japan (issued by the Ministry of Health, Labour and Welfare (MHLW), Pharmaceutical and Medical Devices Agency (PMDA) or Registered Certified Body (RCB);
- Certificates and reports issued under the Medical Device Single Audit Program (MDSAP);
- ISO 13485:2016 certificates issued by a certification body that is also a Notified Body designated under the IVDD 98/79/EC (for IVD inclusion applications only until 26 May 2022)
- ISO 13485:2016 certificates issued by a body that is an accredited body that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) (for IVD inclusion applications only until 26 May 2022)
The six general Essential Principles apply to all devices:
- Use of medical devices not to compromise health and safety;
- Design and construction of medical devices to conform to safety principles;
- Medical devices to be suitable for intended purpose;
- Long-term safety;
- Medical devices not to be adversely affected by transport or storage; and
- Benefits of medical devices to outweigh any side effects.
There are a further nine Essential Principles regarding design and construction that apply to devices on a case-by-case basis:
- Chemical, physical and biological properties;
- Infection and microbial contamination;
- Construction and environmental properties;
- Medical devices with a measuring function;
- Protection against radiation;
- Medical devices connected to or equipped with an energy source;
- Information to be provided with medical devices;
- Clinical evidence; and
- Principles applying to IVD medical devices only.
Products manufactured in Australia (except Class I), containing medicines or substances of animal, biological or microbiological origin, along with Class 4 IVD medical devices, will require an additional review and certificate from the TGA.
Quality System Requirements
Per the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019, the TGA requires manufacturers meet ISO 13485:2016 standards with additional requirements for products sold sterilized. Products using ethylene oxide will need to adhere to ISO 11135:2014, products sterilized with radiation ISO 11137:2006, and aseptic products adhering to ISO 13408.
To change the Australian Sponsor associated with an ARTG listing, the existing sponsor must complete, sign and submit a transfer form to TGA. After the transfer is complete the new Australian Sponsor must take the following steps:
- Submit manufacturers evidence (no TGA fee)
- Prepare and submit Device Change Requests to update the ARTG entries with the Manufacturers evidence (TGA fee is $360/application and the TGA allows up to 10 ARTG entries per application
Timelines and Fees
Medical devices with overseas certification or approval will be eligible for an abridged regulatory review as long as it is for the same design, intended purposes, and indications.
|Medical Device Classification||Application Fee||Est. Review TGA Time||Schedule 5 Part 1|
|Class I – sterile or measuring function||$1,060||4 weeks||Item 1.5(e)|
|Class I – other (excluding export only devices)||$550||Same Day||Item 1.5(g)|
|Class IIa||$1,060||4 weeks||Item 1.5(d)|
|Class IIb||$1,060||6 weeks||Item 1.5(c)|
|Class III||$1,370||6 months (including application audit)||Item 1.5(b)|
|AIMD||$1,370||6 months (including application audit)||Item 1.5(a)|
Application Audit Assessment Fees
Higher risk products (Class III and AIMD) are required to undergo a mandatory Level 2 audit by the TGA, and this information must be provided within 20 working days of request. Level 1 applications audits are determined on a case-by-case basis.
|Type of Application Audit||Assessment Fee||Est. Review Time||Schedule 5 Part 1|
|Level 1 – verification of sponsor’s application and evidence of conformity||$3,990||2 Months||Item 1.13|
|Level 2 – Level 1 activities plus review of clinical evidence, risk management, and efficacy and performance data||$7,310||6 Months||Item 1.14|
*The application audit assessment fee is in addition to the application fee for the inclusion of some medical devices in the ARTG.
Once approved, it will be important for manufacturers with qualifying devices to then list on the Prostheses List which allows for easy reimbursement.
|Medical Device Classification||Fee||Regulation|
|Class III||$1,200||Item 7(4)(d)|
|Class IIb||$940||Item 7(4)(c)|
|Class IIa||$940||Item 7(4)(c)|
|Class I – sterile||$640||Item 7(4)(b)|
|Class I – measuring function||$640||Item 7(4)(b)|
|Class I – other||$90||Item 7(4)(a)|
Benefits of Independent License Holding through Asia Actual in Australia
- Sell directly to multiple regional distributors, avoiding mark-up by a national importer;
- Increase transfer pricing;
- Improve leverage in distributor negotiations/responses;
- Add or change distributors as required;
- Keep intellectual property away from local commercial agents;
- Assure expert handling of post market vigilance and license maintenance;
- Neutral package labeling.
Contact Asia Actual for fast and efficient Australia device registration by an experienced local regulatory professional.
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