The labeling of the medical devices are discussed from the stand point of Good Manufacturing Practices and Quality Management system. It describes about the label content development and label control.
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What is a Medical Device?
Medical devices are defined under section 3, clause (b) of the Drugs and Cosmetics Act, 1940, along with drugs. It should be read with Rule 3 (zb) of the Medical Devices Rules 2017. Medical devices include both the substances (excluding drugs) and the devices which are notified and used for the medical purposes.