REGULATORY ENVIRONMENT FOR MEDICAL DEVICES IN NEW ZEALAND
Abstract
Medical Devices are one of the most important health intervention tools available for the prevention, diagnosis and treatment of diseases and for patient rehabilitation. Although the Medical Devices market in the New Zealand region is very diverse, the existing regulations should be further developed to a greater extent for development of the country’s healthcare sector. Medsafe, the drug and medical device authority of New Zealand has taken steps towards this introducing a web-based online database however, only for the notification of devices in the market which means, there is no premarket assessment for all devices that get sold in the market. The notification process is comparatively very easy and the documentation that is prioritized by Medsafe is only the evidences of the device registration in other countries, like the FDA clearance, the CE certificate or the ARTG listing.
Downloads
References
2. Emergo Group [Internet]. Texas: ‘New Zealand Medical Device Regulatory Strategy Report’. EMERGO; 2015 Oct [Cited 2015 Nov 3]. Available from: www.emergogroup.com/services/new-zealand/new-zealand-regulatory-strategy
3. Medsafe [Internet]. Auckland: ‘Medical Devices’. Official Website of New Zealand Medicines and Medical Devices Safety Authority, NZ Ministry of Health; 2015 Jan [Cited 2015 Dec 11]. Available from: www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp
4. Medical Technology Association of New Zealand [Internet]. ‘Proposal for a New Zealand Regulatory Scheme for Medical Devices’. MTANZ White Paper; 2015 Mar [Cited 2015 Dec 12]. Available from: http://mtanz.org.nz/files-cont/MTANZ%20Proposal%20for%20NZ%20-Regulations.docx
5. Medsafe [Internet]. Auckland: ‘Medical Device Legislations’. Official Website of New Zealand Medicines and Medical Devices Safety Authority, NZ Ministry of Health; 2015 Jan [Cited 2015 Dec 11]. Available from:
www.medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp
6. Medsafe [Internet]. Auckland: ‘Risk Classification of Medical Devices’. Official Website of New Zealand Medicines and Medical Devices Safety Authority, NZ Ministry of Health; 2015 Jan [Cited 2015 Dec 11]. Available from:
www.medsafe.govt.nz/regulatory/devicesnew/3-7RiskClassification.asp
7. Medsafe [Internet]. Auckland: ‘The Web Assisted Notification of Devices Database’. Official Website of New Zealand Medicines and Medical Devices Safety Authority, NZ Ministry of Health; 2015 Jan [Cited 2015 Dec 11]. Available from:
www.medsafe.govt.nz/regulatory/devicesnew/3-2-Explanation.asp
8. Medsafe [Internet]. Auckland: ‘User Guide for WAND – Version 3.1’. Official Website of New Zealand Medicines and Medical Devices Safety Authority, NZ Ministry of Health; 2014 Jul [Cited 2015 Dec 2]. Available from:
www.medsafe.govt.nz/regulatory/devicesnew/NZWandUserGuide.pdf
9. Medical Technology Association of New Zealand [Internet]. ‘About MTANZ’. Official Website of MTANZ; 2016 Feb [Cited 2016 Feb 3].
Available from:
mtanz.org.nz/MTANZ/About-MTANZ-6368.htm
10. Medical Technology Association of New Zealand [Internet]. ‘Proposal for a New Zealand Regulatory Scheme for Medical Devices’. MTANZ; 2015 Mar [Cited 2016 Feb 3]. Available from:
mtanz.org.nz/filescont/MTANZ-Proposal-for-NZ-Regulations.docx
11. Thomson Reuters [Internet]. United States: ‘Research and Markets: New Zealand Medical Device Market: 2015 Edition’. Thomson Reuters Press Release;, 2015 Sept [Cited 2016 Feb 29]. Available from:
http://www.reuters.com/article/research-and-markets-idUSn-Bw255-226a+100+BSW20150925
12. Medical Technology Association of New Zealand [Internet]. ‘New Zealand: Australia New Zealand Therapeutic Products Agency ANZTPA - A proposed regulatory framework for medical devices’. MTANZ; 2013 Dec [Cited 2016 Jan 17]. Available from:
www.fdanews.com/ext-/resources/files/12/12-13-ANZTPA.pdf.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM