How to Export Medical Devices in India

Export Medical Devices 

An industry that export medical devices in India, esteemed at USD 4.9 billion, is moderately little yet has seen unprecedented development over the last few years. Developing at a CAGR of 17% over the last five years, the segment is relied upon to keep witnessing double-digit development with a CAGR of 15% in the coming decade.

The Indian medicinal device market offers an incredible opportunity of its size as well as a result of empowering policies and regulations that the Government has acquainted to give a fillip to the medical device industry.

For instance, the government has upgraded the regulatory framework for the medical device in 2017 and has carried it at standard with international norms by presenting the concept of ‘risk-based’ regulation. The regulatory licenses issued for import, manufacture or sale of medical devices have been made never-ending in nature to eliminate on unnecessary and time-consuming paper-work, in an offer to build simplicity of working together in India.

Importing a medical device into India requires fulfilment of few additional legal requirements than those indicated above. The import of all products in India, including medical devices, is represented under the provisions of the Export and Import Policy. The action of import of Notified Medical Devices into India requires an import license from the office of the Drugs Controller General of India. An application for grant of a registration certificate may be made by the foreign manufacturer itself if it has a valid wholesale license for sale or distribution of Notified Medical Devices under the MDR or its authorized agent in India, either having a valid license under the MDR to manufacture for sale of a Notified Medical Device or having a valid wholesale license for sale or distribution of Notified Medical Devices in India. Numerous times, foreign manufacturers don’t have an Indian subsidiary which has a wholesale license for sale or distribution of Notified Medical Devices. Consequently, the manufacturers select a third party as an authorized agent to influence the application for grant of an import license. The authorization by a manufacturer to its agent in India must be reported by power of attorney.

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