Documentation.
Applicaton Filling.
Grant Invitro Diagnostic Device Import License.
. In India, medical devices are imported, manufactured, distributed, and sold under the Drug and Cosmetics Act 1940 and the Medical Devices Rules, 2017. In this article, we are going too discuss about what is in-vitro diagnostic kits and “benefits of in-vitro diagnostic kits (ivd) import license.The import license documentation supports and intends to prevent the risks associated with medical device design, manufacture, and packaging.
(1) Evalution
(2) Classification
(3) Documentation
(4) Appointment of agent
(5) Form Filling
(6) Approvals of agent
(5) Grant of approval
(1) Evalution of the product, if it requires registrations MDR 2017
(2) If requires registrations evalution of classification based on the product risk category
(3) Appoint authorize agent
(4) Online generation of application
(5) Approval/confirmation of draft application by the authorize agent submission of application
(6) Final approval
(1) Covering Letter.
(2) Regulatory and other documents for attachment as per form MD 14
(3) Power of attorney.
(4) GMP certificate.
(5) PMS report
(6) Audit report
(7) Constitution details of the indian agent
(1) What is Invitro Diagnostic Device Import License?
(2) Where the imported in Vitro diagnostic devices are stocked?
(3) What all license is required from the overseas manufacture for import license?
