New Zealand is revamping its regulations for medical devices to replace the country’s Medicines Act 1981 and its associated regulations.
The proposed regulations mark a significant change for medical devices, which are not fully regulated under current rules.
The agency noted that the current regulations are “dated and inflexible” and reflect the policies of the 1970s when the types of products requiring regulation were simpler.
“The change to full pre- and post-market regulation will be significant, as will any cost recovery,” according to Ministry of Health documents.
Under the proposed regulations, devices would be approved based on their risk classification. Postmarket monitoring by the license holder and the regulator also would be required.
Approvals would be subject to new conditions, such as duties for a responsible person designated for each product. Companies may also need to provide more information on products, and could be subject to new penalties such as warning letters, bans, fines, prosecutions or extra conditions on licenses.
“The implications of some of these changed requirements — e.g., the ability of the regulator to license for longer periods — are likely to reduce compliance costs,” the documents note.
Along with new approval regulations, a framework is needed for regulatory oversight of clinical trials for all therapeutic products, the documents say. They point out that trials of medical devices and some cell and tissue therapeutic products do not currently require approval.
The effects of the new regulations on product availability and pricing “is expected to be slightly favorable.” Flexible approval methods are expected to encourage innovative products, and the extra compliance cost for many devices could have little effect on product pricing.
The document discusses three options for export controls of devices:
A bill outlining the new scheme is expected to be introduced to the country’s parliament later this year, with implementation taking place over several years. The move follows the halting of the Australia New Zealand Therapeutic Products Agency project, and it will “look to align with international standards where appropriate,” said the Ministry of Health.