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Sat, Nov 29 2025
Raju Karn
If you want to import medical devices into India , whether it’s diagnostic equipment, surgical instruments, implants, or machines - you must have an MD-9 Import License issued by the Central Drugs Standard Control Organisation (CDSCO).
In Delhi, where the medical device market is booming across AIIMS area, Dwarka, Rohini, Okhla, Noida, Gurugram, Faridabad, and other NCR clusters, the MD-9 license has become essential for hospitals, traders, distributors, and medical device companies.
This guide explains the requirements, process, documents, fees, timeline, validity, renewal, and how PSR Compliance helps businesses get MD-9 smoothly without delays or objections.
MD-9 is the official CDSCO license required to import Class A & B medical devices into India.
It is issued to importers, wholesalers, manufacturers, and medical distributors dealing with regulated medical devices.
● Surgical equipment
● Diagnostic devices
● Medical tools
● Laboratory equipment
● Consumables
● Hospital-use machinery
● Class A & B devices notified by CDSCO
You need an MD-9 license if you are:
➜ Medical device importer
➜ Distributors/wholesalers
➜ E-commerce sellers supplying medical devices
➜ Hospitals importing machines directly
➜ Diagnostic labs importing equipment
➜ Foreign manufacturers appointing Indian Authorized Agents
In Delhi & NCR, areas with high import volumes include:
Okhla, Naraina, Patel Nagar, Dwarka, Rohini, Noida Sector-63, Gurugram Udyog Vihar, Faridabad Industrial Zone, etc.
Note:If your business deals in imports, MD-9 is mandatory.
1. Legal approval for importing medical devices
2. Required for customs clearance at ports
3. Increases business credibility
4. Makes your company eligible for government tenders
5. Helps you supply to hospitals, labs & distributors
6. Supports e-commerce onboarding (Amazon, Flipkart, 1mg, etc.)
You must upload the following documents on the CDSCO SUGAM portal:
Company Documents
→ Importer’s address proof
→ Pan card of company
→ GST certificate
→ Constitution documents (MOA, AOA, LLP agreement, Partnership deed)
→ Cover letter
Technical Requirements
→ Free Sale Certificate (FSC) from manufacturing country
→ ISO13485 certificate
→ Device Master File (DMF)
→ Plant Master File (PMF)
→ Undertaking for authorized agent
→ CE Certificate (if applicable)
→ Device description & intended use
Authorized Indian Agent Documents
→ Power of Attorney
→ Agreement between manufacturer & importer
→ Valid wholesale drug license (if required)
PSR Compliance prepares all documents professionally to avoid “Queries/Objection” delays from CDSCO.
Here’s the exact process to get MD-9 in Delhi:
‣ Create login on the CDSCO SUGAM portal
‣ Select MD-9 Import License – Class A & B
‣ Upload FSC, ISO, DMF, PMF, and business documents
‣ Pay the applicable government fees
‣ CDSCO reviews the application and may raise queries
‣ Receive the digital MD-9 license on the SUGAM portal
In normal cases:
25–45 working days
(If documents are perfect)
If queries are raised:
Additional 2–3 weeks
PSR Compliance ensures faster approval with zero errors.
PSR Compliance supports companies across Delhi, Noida, Gurugram, Ghaziabad, Faridabad with:
✔ SUGAM portal registration
✔ Document preparation (DMF, PMF, FSC check)
✔ Classification support
✔ Application filing
✔ Reply to CDSCO objections
✔ End-to-end license support
Our team ensures your MD-9 license is approved quickly without back-and-forth with the department.
It is a CDSCO-issued license required to import drugs and medical devices into India legally.
Importers, Indian agents, distributors, wholesalers, and medical device companies.
KYC, import details, device/drug details, wholesale license, and authorization letter.
Approval usually takes 20–30 working days depending on CDSCO review.
The MD-9 license is valid perpetually with timely retention fees.
Yes, a Form 20/21 wholesale drug license is required for importers.
Yes, applicants must apply through the CDSCO online portal.