New Zealand Regulatory Guidelines For Medical Devices

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Regulatory Guidance for Medical Devices - Medsafe

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

Regulatory Guidance Policy Statements Medsafe's policy related to particular types of medical device. More... Importing Medical Devices into New Zealand Obligations for medical device importers. More... Contraceptive Devices Information on standards for …

Current Regulatory Guidelines - Medsafe

https://www.medsafe.govt.nz/regulatory/current-guidelines.asp

Regulatory requirements for medicines and related products. New medicine application (PDF 2 MB, 66 Pages) New and changed related products (PDF 333 KB, 12 pages) …

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 …

Medical Devices Home Page - Medsafe

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

Medicines and Medical Devices Recall Code. Device Information. New Zealand Definitions. Medical Device Legislation. Overseas Medical Device Regulators. If you have a query …

Therapeutic products regulatory regime | Ministry of …

https://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime

and medical devices that range from tongue depressors to implantable pacemakers. Both medical devices and gene, cell and tissue therapies are currently not …

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 ...

Regulatory Guidance - Medsafe

https://medsafe.govt.nz/regulatory/regguidance.asp

Medicines are generally scheduled (ie, classified) according to their active ingredients. The First Schedule to the Medicines Regulations 1984 is a list of ingredients classified as …

Medical device registration and approval in New Zealand - Emergo

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

How are medical devices classified in New Zealand? Do foreign manufacturers need an in-country representative to sell their medical devices in New Zealand? In order to …

New Zealand's Regulatory Environment - MTANZ

https://mtanz.org.nz/Regulatory/6664/

Proposed New Zealand Therapeutic Products Legislation impacting medical devices The New Zealand Government is now preparing legislation to reform the domestic regulatory …

Medical Device Registration, Medsafe, WAND, New Zealand

https://www.freyrsolutions.com/regulatory-services-in-new-zealand

While doing so manufacturers must comply with the region’s regulatory authority –The New Zealand Medicines and Medical Device Safety Authority ( MedSafe) and for medical …

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