New Zealand Medical Device Classification

Risk Classification of Medical Devices - Medsafe

https://www.medsafe.govt.nz/regulatory/devicesnew/3-7RiskClassification.asp

Following the principles of the Global Harmonisation Task Force (GHTF) the New Zealand Regulations have five risk classes and two sub-classes. These classes are based on the potential risk posed by the medical device when used as intended by the manufacturer. …

Regulatory Guidance for Medical Devices - Medsafe

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

Risk Classification of Medical Devices; Exempt Medical Devices; Regulatory Guidance. Policy Statements; Importing Medical Devices into New Zealand; Contraceptive …

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 …

Categorisation of Products - Medsafe

https://medsafe.govt.nz/regulatory/categorisation-of-products.asp

Medical device registration and approval in New Zealand - Emergo

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

Medical device classification in New Zealand New Zealand uses a classification system based on risk to the human body. Increasing risk is assigned to Classes I (self-certified, …

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) does …

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 …

Medicines (Database of Medical Devices) Regulations 2003

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

Medicines (Database of Medical Devices) Regulations 2003 (SR 2003/325) Silvia Cartwright, Governor-General Order in Council At Wellington this 17th day of …

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each classification panel in the CFR begins with a list of devices classified in that panel. Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - …