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International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products

Posted on 2010-04-20




Name:International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products
ASIN/ISBN:B000PMG8S6
File size:17.71 Mb
   International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products

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Helps readers obtain rapid regulatory approval and success in the marketplace

�Explains all aspects of advertising, labeling, and packaging in clear, concise language

�Provides explanations of the relevant laws, regulations, and requirements in major markets worldwide without excess & 8220;governmentese& 8221;

�Uses examples of compliance and noncompliance to demonstrate the concepts discussed in the text

Extensively revised, with an updated title that reflects its expanded scope, International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic Products, Second Edition provides the practical labeling information you need to achieve rapid regulatory approval, gain marketplace acceptance, and assure user comprehension.

A complete guide to all aspects of advertising, labeling, and packaging, the book explains the relevant laws, regulations, and requirements in major markets worldwide. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, OTC products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more. is a comprehensive resource that gives you the tools to stay ahead in the ever-changing regulatory environment.

Contents

1. Argentina and Brazil

2. Australia

3. Canada and Mexico

4. China, Korea, and Thailand

5. European Union

6. Japan

7. United States

8. Development of Device Labels .

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