CDSCO Updates Medical Device Portal; Industry Association Calls for Safeguards Amid Rising Imports

New Delhi, April 16, 2025: India’s national medical device regulator, the Central Drugs Standard Control Organisation (CDSCO), has implemented significant upgrades to its online registration system. This overhaul necessitates that all medical device manufacturers resubmit crucial documentation, specifically market standing and non-conviction certificates, as part of a move aimed at streamlining regulatory processes and improving the ease of doing business.

While the CDSCO focuses on refining its digital infrastructure, a prominent industry body has voiced urgent concerns about market pressures. The Association of Indian Medical Device Industry (AIMED) is calling on the Central Government to intervene against a sharp increase in medical device imports.

AIMED has specifically requested the imposition of safeguard duties on 12 key categories of medical devices. The association highlighted a particularly alarming 80% surge in imports of syringes and needles, with China, the USA, and Singapore identified as the primary sources.

The industry group warns that unchecked imports pose a significant threat to the viability of domestic manufacturers. AIMED further cautioned that potential reductions in import duties resulting from ongoing trade negotiations with the European Union (EU) and the United States could exacerbate the situation. Such developments, they argue, could lead to financial distress for Indian companies, potential job losses, and ultimately hinder India’s goal of achieving self-reliance in the critical healthcare sector.

The simultaneous actions by the regulator and the industry association underscore the dynamic challenges within India’s medical device landscape, balancing regulatory efficiency with the protection and growth of domestic manufacturing capabilities against global market forces.

Disclaimer: This news article is based on information sourced from an article published by The Hindu regarding recent actions by the CDSCO and requests made by AIMED. It aims to summarize the key developments reported therein.