Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on March 21, 2023 by The Health Master
Schedules –All types of Medical Devices under Medical Devices Rules 2017
As per Medical Devices Rules 2017 we have provided all the Schedules introduced in these rules, Click below links for more information:
First Schedule – Parameters for classification of medical devices and in vitro diagnostic medical devices
First-Schedule
Second Schedule – Fee payable for licence, permission and registration certificate
Second-Schedule
Third Schedule – Documents required for registration of Notified Body, its duties and functions.
Third-Schedule
Fourth Schedule – Documents required for grant of licence to manufacture for sale or for distribution or import
Fourth-Schedule
Fifth Schedule – (QMS) Quality Management System for medical devices and in vitro diagnostic medical devices
Fifth-Schedule
Sixth Schedule – Post approval change
Sixth-Schedule
Seventh Schedule – Requirements for permission to import or manufacture investigational medical device for conducting clinical investigation
Seventh-Schedule
Eight Schedule – Exemptions
Eighth-Schedule
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Licensing procedure for Medical devices
Latest Notifications: Medical Devices
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