In Order to Sell the Medical Devices Manufactured Outside India, there is a need to have Import Registration with CDSCO.
CDSCO is the Competent Authority to Review and Approve the Import Registration for All Class A, Class B, Class C and Class D Medical Devices.
Our Experienced Team is familiar with all aspects of Regulatory Compliance Requirements for Medical Devices in India.
Our services include but not limited to Obtaining Medical Device Registration & Approval for Foreign Manufacturers and Their Indian Authorized Representatives / Indian Offices.
We will be Happy to Serve you for Import Registration.
In order to have Import Registration, The foreign manufacturer must have an Indian Authorized Agent. This can be their Own Office, Indian Subsidiary or Independent Agencies.
The Indian Agent is approved by CDSCO and the Foreign Manufacturer can apply for Sugam Registration through Indian Authorized Agent.
CDSCO has Notified through Statutory Order SO648 (Hyperlink to SO 648) and GSR 102E (Hyperlink to GSR 102E) the Compulsory Registration Effective from 1st October 2021. This Compulsory Registration is mandated for All Classes of Medical Devices that are yet to be notified. The classification of Medical Devices is being updated by CDSCO from Time to Time
For Certain Class A and Class B Medical Devices, Import Registration is Exempted Till September 2022 if the Foreign Manufacturers and Indian Importers Do Compulsory Registration as per GSR 102E.
For Certain Class C and Class D Medical Devices, Import Registration is Exempted Till September 2023 if the Foreign Manufacturers and Indian Importers Do Compulsory Registration as per GSR 102E.
Hyper Links to the Classification of Medical Devices
The Import Registration is to be completed by Foreign Manufacturers and Their Importers in India so that they can sell the Approved Medical Devices in India.
The Registration is applied by the Indian Authorized Agent.
Application for All classes of Medical Devices is Submitted on MD-13
Import Registrations are Granted on MD-15 ONLY BY CDSCO.
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DKNSB Medical Device Consultants is backed by 20 years of experience with the aim to provide Technical and Regulatory Support to Medical Device Manufacturers from India and Overseas.
Objective: Hassle-Free Regulatory Approval for Indian Manufacturers, Foreign Manufacturers and Importers.