International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products
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A01=Charles Sidebottom
AIMD
AIMDD
Author_Charles Sidebottom
Can
Category=PS
Class Ii Device
Clinical Investigation
date
Device Labeling
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eq_nobargain
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expiration
general
GENERAL LABELING PROVISIONS
General Labeling Requirements
good
insert
INTRAOCULAR LENSES
IOLS
IVD Device
manufacturing
MDD
Medical Device
Medical Device Labeling
Medical Devices Regulations
Natural Rubber Latex
Outer Container
package
Pal
practice
Premarket Approval Application
Premarket Notification
Principal Display Panel
provisions
serial
Therapeutic Devices
Therapeutic Goods
Therapeutic Goods Act
Unapproved Devices
Product details
- ISBN 9780367395162
- Weight: 453g
- Dimensions: 210 x 280mm
- Publication Date: 23 Sep 2019
- Publisher: Taylor & Francis Ltd
- Publication City/Country: GB
- Product Form: Paperback
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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.
Sidebottom, Charles
