Medical Device Import in India Hits Record Roadblocks in 2025 – Over 12,000 Consignments Stuck!
New Delhi, November 16: Importing life-saving medical devices into India has turned into a nightmare for thousands of companies this year. Medical device import India, CDSCO registration hurdles, customs clearance delay, import licence India delays and strict MDR 2017 compliance are the top five reasons behind massive shipment blocks at Mumbai, Delhi and Chennai ports.
Industry sources reveal that nearly 68% of medical equipment consignments faced detention in the first nine months of 2025, according to the latest Association of Indian Medical Device Industry (AiMeD) data. From cardiac stents and MRI machines to simple glucose monitors – nothing seems to escape the red tape.
“The biggest challenge remains unpredictable CDSCO registration timelines,” says Rajiv Nath, Forum Coordinator of AiMeD. “Companies wait 18-24 months for import licences while patients suffer. Even Class A low-risk devices now need full registration – earlier they were exempt.”
Customs officials often demand fresh documents mid-clearance, leading to demurrage charges running into lakhs daily. A senior importer from Ahmedabad told this reporter, “We paid ₹42 lakh in penalties last month because the consignment note mentioned ‘diagnostic equipment’ instead of the exact CDSCO-approved nomenclature.”
Another pain point is the sudden re-classification of devices under the Medical Device Rules 2017. Many products that were earlier treated as drugs now fall under devices, forcing companies to restart the entire licensing process.
“Public reaction on social media is explosive,” says Dr. G.S.K. Velu, Chairman of Trivitron Healthcare. “Patients are posting pictures of empty ICU beds while ventilators rot at the port. This is not just bureaucracy – it’s a humanitarian crisis.”
Small and medium importers are the worst hit. One Delhi-based distributor shared anonymously, “We ordered 5,000 pulse oximeters in June. Still waiting for clearance in November. Meanwhile Chinese suppliers are laughing all the way to African markets.”
The government introduced the online SUGAM portal to speed up applications, but industry insiders claim the system crashes frequently and verification officers remain overburdened.
Even approved licences come with surprise conditions – some importers received licences valid for only six months instead of the standard five years.
Despite repeated appeals, the timeline for risk-based classification and grouping registration remains painfully slow. Industry experts demand immediate creation of separate notified bodies and third-party testing labs to reduce dependency on CDSCO.
As India aims to become a $50 billion medical device market by 2030, the current import bottlenecks threaten both patient lives and the Make in India dream.
The message from importers is clear: unless medical device import India processes are simplified, CDSCO registration timelines shortened, customs clearance delays eliminated, import licence India issued faster and MDR 2017 compliance made practical – the country will continue paying a heavy price in health and money.
Stay updated with the latest developments on medical device import India, customs clearance delay and CDSCO registration challenges.
Written by: Satish Mehra
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