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.
Modifications and Amendments
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:
The manufacturer’s name/address has changed (only if supporting evidence can be provided that this change does not result in a new legal manufacturer);
The certificate number has changed;
The certificate has expired and been re-issued;
The scope of the certificate has changed;
The conformity assessment procedure, including the manufacturer’s details, has changed;
The notified body has changed;
The EC Certificate has been updated;
The issuer certification number has changed;
The evidence issue date has changed;
The evidence expiry date has changed;
The evidence re-issue date has changed;
Supporting documentation needs to be added;
The annex route has changed.
Schedule 9 Part 2
Variation to an ARTG inclusion entry
Medical Device Classification
Class I – sterile
Class I – measuring function
Class I – other
Contact Asia Actual with any medical device license maintenance questions in Australia. Our local regulatory experts are well positioned to assist.