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International Tools

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

International Tools
Download

Global harmonisation of Medtech regulations

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

Download

Europe's Proposed Medical Device Regulation

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

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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.

Download

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.

Download

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.

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The NHS Atlas of Variation in Healthcare

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

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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)

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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.

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Reference Guide to Medical Device Registration in Japan June 2009

(Adobe PDF) 1798KB

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UK Trade and Investment Market Support Presentation March 2009

(Adobe PDF) 445KB

Download

UK Medical Technologies Workshop March 2009

(Adobe PDF) 650KB

Download

China Medical Device Registration August 2008

(Adobe PDF) 211KB

Download

Reference Guide to FDA and Reimbursement in the US May 2008

(Adobe PDF) 201KB


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