Manufacturing License in Delhi – The demand for a medical device manufacturing license in Delhi has surged in 2026 as India’s medical device sector continues its explosive growth. Whether you’re starting a new manufacturing unit or expanding your existing business, obtaining a CDSCO manufacturing license Delhi or approval from the Delhi State Licensing Authority is now mandatory for legal production and sales. This comprehensive step-by-step guide walks you through the entire process to secure your Delhi medical device manufacturing license smoothly and compliantly.
India classifies medical devices into four risk classes — Class A, B, C, and D — and the licensing pathway in Delhi depends on this classification. Low-risk Class A and B devices are generally approved by the Delhi State Licensing Authority, while higher-risk Class C and D devices require approval from the Central Licensing Authority at CDSCO headquarters in New Delhi.
Step 1: Determine Your Device Classification The first and most critical step is accurate risk classification of your medical device as per the Medical Devices Rules, 2017 (as amended in 2025-2026). Use the latest CDSCO classification lists available on the SUGAM portal. Misclassification can lead to rejection or delays.
Step 2: Register on the SUGAM Portal All applications are submitted online through the official CDSCO SUGAM portal (cdscomdonline.gov.in). Create a new account using your company details, PAN, GST, and authorized signatory information. Link your manufacturing site details early for faster processing.
Step 3: Prepare Required Documents Key documents include: • Plant Master File (PMF) and Device Master File (DMF) • ISO 13485:2016 Quality Management System certificate • Site layout plan, equipment list, and technical staff qualifications • Proof of premises ownership/lease agreement • Cover letter, undertakings, and declarations • Fee payment challan
Step 4: Submit the Application • For Class A & B: File Form MD-3 to the Delhi State Licensing Authority → License granted in Form MD-5 • For Class C & D: File Form MD-7 to the Central Licensing Authority (CDSCO) → License granted in Form MD-9
Upload all documents and pay the applicable government fees online.
Step 5: Pay the Fees Fees for manufacturing license (2026 rates): • Class A/B: ₹5,000 per site + ₹500 per device • Class C/D: ₹50,000 per site + ₹1,000 per device
Step 6: Undergo Facility Inspection After submission, inspectors from the respective authority will visit your manufacturing facility to verify GMP compliance, infrastructure, and quality systems. Delhi-based applicants benefit from faster scheduling because both the State Licensing Authority and CDSCO headquarters are located in the capital.
Step 7: Respond to Queries and Receive Your License Address any queries raised within the stipulated timeline. Once approved, you will receive your manufacturing license, which is generally valid for 5 years with mandatory renewal and post-market surveillance.
This medical device manufacturing license in Delhi process typically takes 3 to 9 months depending on the class and completeness of your application. Starting early and ensuring full documentation significantly improves approval chances.
In 2026, with digital enhancements to the SUGAM portal and stricter enforcement of mandatory licensing, getting your medical device manufacturing license in Delhi has become more streamlined yet more regulated than ever before. Proper compliance not only avoids penalties but also builds trust with hospitals, distributors, and government tenders.
By Mark Smith
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