ABSTRACT

Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets w

part |2 pages

PART I Negotiating a Common Understanding

part |2 pages

PART II Argentina and Brazil

chapter 2|8 pages

Argentina

chapter 3|6 pages

Brazil

part |2 pages

PART III Australia

part |2 pages

PART IV Canada and Mexico

chapter 7|22 pages

The Food and Drugs Act of Canada

chapter 8|42 pages

General Medical Device Labeling in Canada

chapter 10|10 pages

Mexico

part |2 pages

PART V China, Korea, and Thailand

chapter 11|18 pages

People’s Republic of China

chapter 12|8 pages

Republic of Korea

chapter 13|8 pages

Thailand

part |2 pages

PART VI European Union

part |2 pages

PART VII Japan

chapter 18|16 pages

The Pharmaceutical Affairs Law of Japan

chapter 19|22 pages

General Medical Device Labeling in Japan

part |2 pages

PART VIII United States

part |2 pages

PART IX Development of Device Labels

chapter 27|10 pages

Reducing Labeling Problems

chapter 28|8 pages

Designing Good Labeling