New Zealand WANDers towards increased device regulation
If you are WANDering about the title of this blog, yes, it’s a dreadful pun I know – but it’s that time of year. New Zealand’s Medsafe have issued a pre-Christmas gift to the industry with an exposure draft of the proposed new Medicines Act which includes substantial changes to medical device regulation.
Of particular note are new premarket requirements. Under the existing Web Assisted Device Notifications Database (WAND) the manufacturer only needs to file an online notification of supply, and no more. There is a voluntary arrangement to add to the notification details of existing international requirements, but it is only voluntary. The new regulations introduce a formal requirement for conformity assessment evidence.
Medsafe have indicated they will accept evidence from any 3rd Party assessor or Competent Authority in whom they have confidence. This is likely to translate into acceptance of regulatory approvals in most major jurisdictions including US, Europe, Canada, Japan and Australia.
The new draft also tightens some postmarket regulations and provides much needed clarification as to the responsibilities of sponsors and the contractual relationships they need to have with manufacturers, as well as that they be competent to meet regulatory requirements and be a fit and proper person.
This tightening of NZ requirements will curb some of the early releases in New Zealand and essentially require that products on the New Zealand Market will all have been subject to competent international review. The consultation document notes that Medsafe will not themselves be offering device assessment services. The agency is, instead, relying on work already done by international regulators.
See the Consultation document and links to the exposure draft at https://www.health.govt.nz/publication/therapeutic-products-regulatory-scheme-consultation
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