New Zealand Medical Device Regulations

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Regulatory Guidance for Medical Devices - Medsafe

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

Regulatory Guidance for Medical Devices Home Devices Regulatory Guidance Revised: 23 October 2019 Medical Devices Regulatory Guidance Policy Statements Medsafe's policy related to particular types of medical device. More... Importing Medical Devices into …

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 …

Therapeutic products regulatory regime | Ministry of …

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

This will include: regulating medicines from general sale products like paracetamol to gene, cell and tissue therapies, and medical devices that range from …

Medical device registration and approval in New Zealand - Emergo

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

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

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

These regulatory functions are performed by the Ministry’s business units, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), which is …

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 …

Medicines (Database of Medical Devices) Regulations 2003

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

These regulations are administered by the Ministry of Health. Pursuant to section 105of the Medicines Act 1981, Her Excellency the Governor-General, acting on …

Regulatory Affairs - MTANZ - Medical Technology Association of …

https://mtanz.org.nz/Regulatory-Affairs/6641/

From that date, a sponsor (i.e. any New Zealand-based person or organisation that is manufacturing or importing medical devices for supply in New Zealand, or exporting …

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 …

Medical Device Registration in New Zealand

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 Representative. Determine the product …

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