Select Relevant Account

Select yourself to see only your informmation.
Select an organisation to manage it as well.


Forgot password?
Create an Account

International Tools

Listed below are links to documents which may be useful resources when navigating the export markets.

International Tools

MFAT Monitoring International Supply Chains June 2

(Adobe PDF) 1442KB
Summary of issues facing international supply chains as a result of COVID 19.


MFAT Consolidated list of trade affecting measures in response to COVID19

(Adobe PDF) 869KB


Global harmonisation of Medtech regulations

(Adobe PDF) 129KB
Fact Sheet with basic information about GMDN and its relationship to UDI


Europe's Proposed Medical Device Regulation

(Adobe PDF) 909KB
A white paper by Emergo Group published October 2012


FDA Assurance Case Submissions

(Adobe PDF) 622KB
Software technology enables an increasing percentage of medical device
functionality, leading to much more complex systems and presenting a
challenge to regulators charged with evaluating device safety and effectiveness.
An approach to evaluating claims of safety increasingly used in Europe
and elsewhere is the safety assurance case. Much like a legal case,
the assurance case lays out an argument and supporting evidence to show
that safety claims are valid. This technical note explores the use of
assurance cases for justifying claims of medical device safety. It illustrates
the use of the assurance case on a particular type of medical device—the infusion pump.

This example serves as a basis for discussing issues surrounding the introduction of assurance cases into the medical device community, which includes both manufacturers and the U.S. Food and Drug Administration.


Medical Device Guidance

(Adobe PDF) 346KB
Singapore's Health Sciences Authority has issued revised guidance explaining when device companies should notify the authority about changes made to a product registered on the Singapore Medical Device Register.


CDRH Innovation Initiative

(Adobe PDF) 515KB
The Innovation Initiative proposes actions CDRH could take to help accelerate and
reduce the cost of development and regulatory evaluation of innovative medical
devices safely and based on sound science.


The NHS Atlas of Variation in Healthcare

(Adobe PDF) 3732KB
Reducing unwarranted variation to increase value and improve quality. November 2010


Doing Business in the US: Medical Devices and Pharmaceuticals

(Adobe PDF) 1708KB
This book provides companies with an overview of the US market and the steps involved in launching a medical device or pharmaceutical product.

(Hard copies of this book are available through MTANZ)


Medical Device Regulatory Process Chart

(Adobe PDF) 1160KB
Created by Emergo Consultants this document provides a thorough and up-to-date indication of the regulatory process in various international regions.


Reference Guide to Medical Device Registration in Japan June 2009

(Adobe PDF) 1798KB


UK Trade and Investment Market Support Presentation March 2009

(Adobe PDF) 445KB


UK Medical Technologies Workshop March 2009

(Adobe PDF) 650KB


China Medical Device Registration August 2008

(Adobe PDF) 211KB


Reference Guide to FDA and Reimbursement in the US May 2008

(Adobe PDF) 201KB

Get Adobe Reader

Note: PDF files require Adobe® Acrobat® Reader. This is free software that lets you view and print Adobe Portable Document Format (PDF) files. If you do not have the free Acrobat Reader software you will need to download it from the Adobe Web Site before you can view and print PDF documents.


©copyright Medical Technology Association of New Zealand, all rights reserved. Privacy Policy and Disclaimer.

Powered by streamSWEET CMS