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

Product Description 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 worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more. Review "an asset to the medical device industrycontinues to provide practical guidance for industry to facilitate international regulatory approvals and appropriately educate users in today's environment." - From the foreword by Charles H. Swanson, Ph.D., Vice President and Chief Regulatory Officer, Medtronic, Inc. Promo Copy About the Author Sidebottom, Charles