Medical Device and IVD Import License/Approval in India | CliniExperts

Описание: Here, you can know step by step how to obtain a medical device & In-vitro diagnostics devices import license in India. Understand the steps involved for manufacturers and importers of medical devices and in-vitro diagnostic devices and measures for manufacturers and importers of medical devices.
All medical devices come under the supervision of the Central Drugs Standard Control Organisation (CDSCO). All medical devices and IVD's are classified into four categories, from A to D, depending upon their indications for use and the risk level of such a device. The government timelines to obtain medical device licenses in India have been specified in MDR 2017. As per Medical device amendment 2020, w.e.f April 1st, 2020, the importers or manufacturers may voluntarily apply for registration in India till September 30th, 2021.

Post 30th September 2021 mandatory registration of devices shall be applicable based on their risk classification. Medical device license validity shall be renewed every five years
The Medical Devices Rules, 2017 also brought changes in some fundamental forms.
Form MD-14 enables an authorized agent to apply for an import license for medical devices & in-vitro devices on behalf of the manufacturer and importer. The import license shall be obtained in Form MD-15. Form MD-26 is the application for importing or manufacturing a medical device that does not have a predicate or any similar medical device in the Indian market, whereas Form MD-27 is the license granted.

CliniExperts is an authorized agent for overseas manufacturers to register their devices and also possessing a wholesale license in Form 20B and 21B to sell the devices to distributors in India.