NZ Makes it Formal – Medical Devices Reform in The Land of the Long White Cloud
New Zealand has always been a relaxed sort of place – and that included the regulation of medical devices which up till now has been limited to a simple notification process and postmarket controls with very limited regulatory foundations.
That’s all about to change as the New Zealand regulator MedSafe consults on the completely re-written exposure draft of the Medicines Act, which includes much stronger controls of medical devices.
Current Controls – waving the magic WAND
Right now, the only requirement for supply of a medical device in New Zealand is for filing of a notification by the local sponsor – which must be a New Zealand legal entity. The sponsor lodges an online notification via the Web Assisted Notification of Devices (WAND) portal providing administrative details of manufacturer and sponsor contacts, and of the devices supplied. Any international approvals should be included in the notification, but they are not a prerequisite for New Zealand supply.
New Zealand is a small yet sophisticated market and this rather laissez faire approach has to date not led to anything particularly untoward.
But it’s been clear that the world has moved on and the redrafting of the Medicines Act has provided the opportunity to bring devices regulation into line with internationally harmonized practice. The new Act introduces a range of more rigorous requirements.
- Premarket Approvals
Devices supplied in New Zealand must now be subject to a conformity assessment. However, that doesn’t mean that MedSafe is suddenly hiring reviewers. Instead MedSafe intends to rely entirely on prior reviews performed by respected international regulators. The practical effect is that the WAND notification will now require evidence of an approval by an international regulator such as a CE mark or approval by Australia, Canada, Japan or the USA.
- Stricter Sponsor Requirements
The new act defines a sponsor much more clearly and explicitly sets out to prevent parallel importing. The requirement is that there should be only one sponsor for a product. However, that does not prevent importing directly by one or more distributors or even direct to user. But such imports require the consent of the sponsor.
The practical impact is that a sponsor must have formal written agreements in place with the manufacturer and with all other local parties including distributors – to ensure compliance is maintained, distribution is tracked, communications with MedSafe are managed and everyone is in the loop.
An important protection for sponsors is that anyone conducting parallel import without the consent or knowledge of the sponsor is committing an offence, and the sponsor does not bear any responsibility.
- Significant Changes
Management of product changes is always a tricky issue in any regulatory jurisdiction. The new Act makes it a requirement that any substantial change to a product is considered to result in a new device and requires a new approval. This is not as drastic as would first appear. Remember, MedSafe is relying on WAND notification supported by international premarket certifications. So, the practical effect is that a substantial change would be one which would require e.g. an update to a CE certificate or Canadian license or submission of a new 510(k). Once granted the manufacturer would simply need to notify via WAND submission, a new device and submit the updated certificate.
- Postmarket with Teeth
The new medicines act provides much stronger postmarket controls – with mandatory adverse event reporting (previously voluntary) and formal recalls and advertising controls which are very closely aligned with those of Australia.
- Clinical Trials
One of the most significant and perhaps controversial changes in the new Act is an introduction for the first time of requirements for MedSafe prior approval of clinical trials.
Straightforward and light touch regulations have resulted in New Zealand being a popular venue for early clinical studies on new technologies. The sophisticated health care environment means that clinical data generated in New Zealand are well respected and offer an efficient and cost-effective path to valuable early stage data for product development and regulatory validation.
The new requirement for MedSafe review and approval of trials, in addition to ethics committee (Institutional Review Board/IRB review goes further than the current Australian rules – where device and IVD trials are generally regulated by notifications under CTN scheme. MedSafe’s consultation document proposes that “online tools would be used to expedite the submission of applications and their consideration” – but it remains to be seen how this will work in practice.
The end result is a regulatory framework which is very closely based on the GHTF model used in Australia, but with complete reliance on premarket assessments done by international regulators. Across the ditch, Australia’s TGA recently broadened its acceptance of international certifications to support Australian approvals – so this is not without precedent.
MedSafe plans a transition to implementation of the full regulations over 2022/2023. The full consultation document is available here. The closing date for submissions is 18 April 2019.
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