Regulatory Strategies for OTC Switch Programs, Implementing EU MDR & IVDR and a Preview of January
By Gloria Hall -
Published 22 December 2017
Feature articles over the past several weeks provided background, approaches, regulatory considerations, and strategies for implementing prescription to Over-the-Counter (Rx-to-OTC) switch programs; CE marking requirements of IVD medical devices under the new EU regulation; explanation of Annex I general requirements and essential requirements; implementation strategies for the new EU medical devices regulations; and medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes in India.
Categories: Features, India, Europe, US, Clinical, Over the counter drugs, Prescription drugs, In vitro diagnostics, Medical Devices
Tags: Feature Editorial