Listed below are links to documents which may be useful resources when navigating the export markets.
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International Tools
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(Adobe PDF) 1442KB
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Summary of issues facing international supply chains as a result of COVID 19.
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(Adobe PDF) 869KB
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(Adobe PDF) 129KB
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Fact Sheet with basic information about GMDN and its relationship to UDI
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(Adobe PDF) 909KB
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A white paper by Emergo Group published October 2012
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(Adobe PDF) 622KB
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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.
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(Adobe PDF) 346KB
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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.
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(Adobe PDF) 515KB
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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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(Adobe PDF) 3732KB
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Reducing unwarranted variation to increase value and improve quality. November 2010
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(Adobe PDF) 1708KB
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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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(Adobe PDF) 1160KB
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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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(Adobe PDF) 1798KB
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(Adobe PDF) 445KB
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(Adobe PDF) 650KB
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(Adobe PDF) 211KB
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(Adobe PDF) 201KB
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