Approval Of Medical Devices In New Zealand

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Regulatory Guidance for Medical Devices - Medsafe

https://www.medsafe.govt.nz/regulatory/devicesnew/industry.asp

Advertising of Medical Devices; Conducting Clinical Trials in New Zealand; Surgical Mesh. Adverse Event Reporting; Medsafe Actions; Information for Healthcare Professionals; Response Implementation; Overseas Actions; Safety Information. Recalls and …

Medical Devices Home Page - Medsafe

https://medsafe.govt.nz/devices/devices-landing.asp

Information for Medical Device Suppliers. Medicines and Medical Devices Recall Code. Device Information. New Zealand Definitions. Medical Device Legislation. Overseas …

Medical device registration and approval in New Zealand - Emergo

https://www.emergobyul.com/services/medsafe-medical-device-registration-new-zealand

The Web Assisted Notification of Devices (WAND) …

https://www.medsafe.govt.nz/regulatory/DevicesNew/3WAND.asp

The Web Assisted Notification of Devices (WAND) Database. For medical devices to be legally supplied in New Zealand they must be notified to the WAND database. …

Medical Device Legislation - Medsafe

https://www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp

The Medicines Act 1981 and its Regulations describe the regulatory scheme for the supply of medical devices in New Zealand. However, some medical devices may be affected by …

Approval Process - Medsafe

https://medsafe.govt.nz/Medicines/regulatory-approval-process.asp

Approval Process Home Medicines Approval Process Revised: 4 September 2019 Medicines Approval Process Medsafe's Evaluation and Approval Process Information …

Medical Device Registration in New …

https://omcmedical.com/medical-device-registration-in-new-zealand/

Medical Device registration is processed via the WAND (Web Assisted Notification of Devices) database. Determine the Device Classification. Appoint an Authorized …

New Zealand Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/new-zealand/

A medical device means any device instrument, apparatus, appliance or other article-- (i) is intended to be used in, or, or for human beings for a therapeutic purpose; and (ii) …

Decision to list medical devices supplied by Geistlich …

https://pharmac.govt.nz/news-and-resources/consultations-and-decisions/decision-2023-02-13-dental-sdeac-ivoclar-geistlich/

We are pleased to announce the approval of a listing agreement with Geistlich Pharma New Zealand (“Geistlich”) and Ivoclar Vivadent Limited (“Ivoclar …

Q&A: pharma & medical device regulation in New Zealand

https://www.lexology.com/library/detail.aspx?g=f73dafa5-a1fd-46cc-b2d1-d8962dfb2a54

To apply for approval, a new medicine application (NMA) must be made to Medsafe, together with a supporting dossier of clinical data, proposed labelling and …

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