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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 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:
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.
The six general Essential Principles apply to all devices:
There are a further nine Essential Principles regarding design and construction that apply to devices on a case-by-case basis:
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.
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:
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) |
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 |
AIMD | $1,200 | Item 7(4)(d) |
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) |
Contact Asia Actual for fast and efficient Australia device registration by an experienced local regulatory professional.
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US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: inquiry@asiaactual.com
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