India is counted among the top 20 global medical devices market and is presently valued at USD 11 billion and is expected to reach USD 65 billion by 2024. The Indian medical device market is dominated by imported products, which comprise of around 80% of total sales.

The Indian medical device market offers a great opportunity not only in terms of its size, but also because of encouraging policies and regulations that the Government has introduced to give a fillip to the medical device industry. For instance, in March 2020, the government approved ‘Production-Linked Incentives (PLI) Scheme for Medical Devices. Earlier in 2019, the government undertook to set up four medical devices parks in Andhra Pradesh, Telangana, Tamil Nadu and Kerala. The medical device parks are expected to reduce manufacturing costs, as these will be equipped with the necessary infrastructure. In addition to PLIs, as of 2023, the Government is also considering offering Research Linked Incentives (RLIs) for indigenous research and production.

The regulatory landscape for medical devices in India has undergone a colossal revamp in 2020 and the Government is still in the process of implementing the same. In this paper we have outlined the legal and regulatory landscape India and the India-specific considerations global medical device companies should keep in mind. In addition, we also discuss entry strategies, intellectual property considerations and the tax regime that affects the medical device industry in India.

Regards,

Varsha Rajesh, Eshika Phadke, Darren Punnen and Dr.Milind Antani

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