Medical Device Regulations In New Zealand

Regulatory Guidance for Medical Devices - Medsafe

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

Medical Devices 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 …

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

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 ...

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 …

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 …

Medical Device Registration in New Zealand

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

Medicines (Database of Medical Devices) Regulations 2003 Official Language: English Classification: Class I, IIa, IIb, III and AMIND Registration Process: Medical Device registration is processed via the WAND (Web …

Medical Device Registration and Approval in New Zealand

https://arazygroup.com/new-zealand/

Electrically powered devices may be regulated by the Energy Safety Service, irradiating apparatus by the National Radiation Laboratory, devices containing hazardous …