New Zealand Medical Device Requirements

At Manningham Medical Centre, you can find all the data about New Zealand Medical Device Requirements. We have collected data about general practitioners, medical and surgical specialists, dental, pharmacy and more. Please see the links below for the information you need.

Regulatory Guidance for Medical Devices - Medsafe

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

Regulatory Requirements for Sponsors; Risk Classification of Medical Devices; Exempt Medical Devices; Regulatory Guidance. Policy Statements; Importing Medical Devices into New Zealand; Contraceptive Devices; In-Vitro Diagnostic (IVD) Devices; …

Labelling of Medical Devices and Instrictions for Use …

https://medsafe.govt.nz/Devices/labelling-and-ifu.asp

The Medicines Regulations 1984 establish minimum requirements for labelling of medical devices in New Zealand. Medical devices are expected to be …

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 …

Current Regulatory Guidelines - Medsafe

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

Regulatory requirements for medical devices. ( Under construction please refer to the guidance for medical devices for current guidance) Manufacturing Manufacture of …

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 …

Frequently Asked Questions - Medsafe

https://medsafe.govt.nz/regulatory/DevicesNew/faqs.asp

In NZ an accessory to a medical device is regulated as a medical device and must be notified separately. A system is a group of devices intended to be used together. A single …

Medical device registration and approval in New Zealand - Emergo

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

Do foreign manufacturers need an in-country representative to sell their medical devices in New Zealand? In order to commercialize your product in New Zealand's small yet well …

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 …

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 Requirements for Sponsors - Medsafe

https://www.medsafe.govt.nz/regulatory/devicesnew/3-6RegulatoryRequirements.asp

Medical Devices Regulatory Requirements for Sponsors Sponsors of medical devices are required to meet all of the requirements of the Medicines Act 1981, the Medicines …

Need more information about New Zealand Medical Device Requirements?

At Manningham Medical Centre, we collected data on more than just New Zealand Medical Device Requirements. There is a lot of other useful information. Visit the related pages or our most popular pages. Also check out our Doctors page.