• 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 "governmentese"
• 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. International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products is a comprehensive resource that gives you the tools to stay ahead in the ever-changing regulatory environment.

Contents

1. Argentina and Brazil
   • Argentina
   • Brazil

2. Australia
   • The Therapeutic Goods Act of Australia
   • General Therapeutic Device Labeling in Australia
   • The Therapeutic Goods Amendment of 2002

3. Canada and Mexico
   • The Food and Drugs Act of Canada
   • General Medical Device Labeling in Canada
   • Radiation-Emitting Device Labeling in Canada
   • Mexico

4. China, Korea, and Thailand
   • People's Republic of China
   • Republic of Korea
   • Thailand

5. European Union
   • The European Medical Device Directives
   • The Medical Device Directive (MDD)
   • The Active Implantable Medical Device Directive (AIMDD)

6. Japan
   • The In Vitro Diagnostic Device Directive (IVDD)
   • The Pharmaceutical Affairs Law of Japan

7. United States
   • General Medical Device Labeling in Japan
   • The Federal Food, Drug, and Cosmetic Act
   • General Device Labeling in the United States
   • In Vitro Diagnostic Product Labeling
   • Radiation-Emitting Device Labeling
   • Bringing Devices to Market in the United States

8. Development of Device Labels
   • Special Labeling Requirements for Specific Devices in the United States
   • Reducing Labeling Problems
   • Designing Good Labeling

Appendix A: U.S. Department of Commerce Medical Device Product Categories/Classification
Appendix B: Australian Department of Health and Aging Classification of Devices
Appendix C: International Symbols for Medical Device Marking
Appendix D: Korean Medical Device Classification
Appendix E: Japanese Medical Device Classification
Appendix F: U.S. Department of Health and Human Services Medical Device Classification
Appendix H: Useful Web Sites

Glossary of Acronyms
References

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