Documentation.
Applicaton Filling.
Grant of CDSCO Medical Device Import License.
The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, coordination of the activity of State Drug Control Organizations.CDSCO has set a complete procedure for granting license for medical devices imported in the country.
There are two types CDSCO Medical Device Import License
(1) Non notified medical devices
(2) Notified medical devices
(1) Determination If your product requires registration
(2) Appointment an authorized indian agent
(3) Submit the regulatory dossier under from 40
(3) Marketing in india
(1) Brand Name.
(2) Intendent use.
(3) Material of construction.
(4) Mode of application.
(1) What is CDSCO medical device import license?
(2) Does a medical device import require license from indian FDA?
(3) How can i get an import license in india?
(4) What is the time period for grant of a medical device import license?
