Tools

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

International Tools
	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

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