Historically, medical devices in India have been mostly unregulated. That has changed in recent years, as some devices have been classified as medical devices, and as India’s Central Drug Standard Control Organisation (CDSCO) has introduced guidelines applicable to medical devices and appointed its Central Licensing Approval Authority (CLAA) with responsibility for medical device oversight.
However, at present, the CLAA only requires pre-market reviews of certain categories of medical devices, including cardiac stents, heart valves, orthopaedic implants and intraocular lenses. In addition, some of the medical devices such as condoms, IUDs tubal rings, blood bags etc are regulated as Drugs.
In addition, regulated medical devices imported from outside of India that have obtained prior approval in the U.S., the European Union (EU), Canada, Japan or Australia may legally be sold in India by submitting a technical dossier and getting necessary approvals which lead to limited conformity assessment process. In such cases, device registration applicants must submit all documentation used in support of prior approvals with their application. Foreign manufacturers must also appoint an importer holding a valid wholesale license, and who is responsible for submitting a device registration application and dossier to the CLAA.
It is important to note that national comprehensive legislation is pending that is expected to significantly expand the scope of medical device regulation in India. Proposed amendments to India’s Drugs and Cosmetics Act would likely overhaul existing regulations and standards applicable to medical devices, and potentially alter lead times for device approval and costs.