Transition to the joint regulatory scheme for medical devices
19 August 2005
Introduction
- Transitional arrangements will be required to give sponsors and manufacturers of medical devices in Australia and New Zealand time to achieve compliance with regulatory requirements under the joint scheme. These arrangements will be based on the principles set out in the Treaty.
- Sponsors of medical devices who are legally supplying those products in Australia or New Zealand prior to commencement of the joint scheme will qualify for a transitional approval to be known as an interim product licence. This licence will authorise the continued supply of the medical device, in the jurisdiction in which it was previously being lawfully supplied, for the duration of a defined transition period.
- If a medical device is included on WAND prior to commencement of the Agency, the sponsor of the product will be issued an interim licence so it can still be marketed in New Zealand only. If a medical device is included on the Australian Register of Therapeutic Goods (ARTG) prior to commencement of the joint agency, the sponsor of the product will be issued an interim product licence permitting continued supply in Australia only. Interim product licences will be valid for three years, however the manufacturer of the medical device must hold a valid manufacturing licence after two years.
- Manufacturers of medical devices who are lawfully manufacturing prior to commencement of the joint scheme will qualify for a transitional manufacturing approval, authorising the continued manufacture of those products for the duration of a defined transition period.
- Any manufacturer who holds a valid manufacturing licence issued by Medsafe or the TGA prior to commencement of the Agency will be issued an interim manufacturing licence. Interim manufacturing licences will be valid for two years.
- Interim product licences and interim manufacturing licences will be issued automatically based on approved product and manufacturing details held by the TGA and Medsafe prior to commencement of the joint agency.
- Lawful, unlicensed manufacturers of medical devices in New Zealand prior to the commencement of the Agency will be granted an authorisation that will enable them to continue the activities that they were lawfully undertaking prior to the commencement of the Agency for a maximum period of two years. In order for these authorised manufacturers to be recorded and issued with an authorisation, an interim database of unlicensed manufacturers will need to be established prior to the commencement of the Agency.
- For medical devices manufactured by a New Zealand manufacturer who holds a manufacturing authorisation, interim product licences to enable access to the New Zealand market for new products may be issued following commencement of the Agency provided labelling and advertising standards are met and that the manufacturer makes a declaration that the devices comply with the essential principles.
- A full joint agency product licence can be issued if the manufacturer holds either an interim or full joint agency manufacturing licence but not if the manufacturer is only an authorised manufacturer.
- Following commencement of the joint scheme, anyone who manufactures or supplies a medical device without holding either an interim or a full joint agency licence (or authorisation in the case of previously unlicensed lawful manufacturers) authorising them do so, will be acting unlawfully and will be exposing themselves to enforcement action by the Agency.
- Persons who wish to continue to supply and/or manufacture medical devices beyond the end of the defined transition period must apply to the Agency for a full joint agency product licence or manufacturing licence and must meet all the requirements of the joint scheme.
- To obtain a full joint agency product licence, products must comply with all the applicable standards.