New Zealand Medical Device Regulation

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Regulatory Guidance for Medical Devices - Medsafe

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

New Zealand Medicines and Medical Devices Safety Authority. Search: Medicines. Medicine Information; Approval Process; Regulatory Guidance; ... Importing Medical Devices into New Zealand. Obligations for medical device importers. More...

Medical Device Legislation - Medsafe

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

Legislation. 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 …

Therapeutic products regulatory regime | Ministry of …

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

We are working on a modern, comprehensive, cost effective regulatory regime for therapeutic products in New Zealand, which will replace the Medicines Act …

Medical Devices Home Page - Medsafe

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

[email protected]

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) …

New Zealand's Regulatory Environment - MTANZ

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

The Medicines (Database of Medical Devices) Regulations 2003 came into force on 1 January 2004. These Regulations require the Director General of Health to maintain a …

Medical device registration and approval in New Zealand - Emergo

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

Although pre-market approval of medical devices is not necessary in New Zealand, market entry does require listing your product in MedSafe's Web Assisted Notification of Devices …

New Zealand Medical Device Regulations | RegDesk

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

Class III. Pre-market approval of medical devices is not necessary in New Zealand (NZ). However, NZ requires theÂ manufacturer to comply with established standards, enforced …

Medicines (Database of Medical Devices) Regulations 2003

https://www.legislation.govt.nz/regulation/public/2003/0325/latest/DLM224223.html

Pursuant to section 105 of the Medicines Act 1981, Her Excellency the Governor-General, acting on the advice of the Minister of Health tendered after …

Medical Device Registration in New Zealand

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

Ministry of Health New Zealand. Regulatory Authority: New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) Medical Device Regulation: Medicines Act 1981. Medicines Regulation 1984. …

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