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License maintenance is an important consideration for manufacturers selling medical devices in Australia as failures to comply could lead to loss of market access, revocation of approval, suspension of business activities and administrative sanction fines that can significantly affect sales.
Along with receiving periodic assessments by an approved Conformity Assessment Body or the TGA, manufacturers will also need to pay an annual fee to maintain the products inclusion on the Australian Register of Therapeutic Goods (ARTG) and are invoiced every August.
The TGA does allow manufacturers to modify their Listings that have been approved by an acceptable entity. A straightforward variation application is necessary with updated certificates.
The following are examples of acceptable Manufacturers Evidence Amendments that may not require a new registration:
Application type | Application Fee | Schedule 9 Part 2 |
Variation to an ARTG inclusion entry | $470 | Item 2A(g) |
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 with any medical device license maintenance questions in Australia. Our local regulatory experts are well positioned to assist.
US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Inquiry@asiaactual.com
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