Medical Device Traders Registration (MD-42)
Obtain your MD-42 licence to import and trade medical devices legally in India.
About this service
Under the Medical Devices Rules 2017, all importers and distributors of medical devices in India must obtain Form MD-42 registration from the Central Drugs Standard Control Organisation (CDSCO). Confitax helps medical device businesses navigate the complex CDSCO application process, ensuring correct product classification, document preparation, and submission.
A simple, guided process.
We handle the complexity so you can focus on your business. Here's your journey from start to finish.
Device classification
We classify your medical device under Class A, B, C, or D as per Schedule II of Medical Devices Rules 2017.
Application preparation
Prepare MD-42 application with device technical documents, ISO certificates, and manufacturer agreements.
CDSCO submission
Submit on the SUGAM portal. CDSCO reviews and issues the MD-42 registration within 30–90 days.
Why choose this service?
Here's how this service adds tangible value to your business — from compliance and credibility to cost savings.
Legal Compliance
MD-42 registration is mandatory — importing or trading without it attracts heavy penalties and seizure.
Import Authorization
With MD-42, you're authorized to import your registered medical devices through any Indian port.
Market Access
Access government tenders, hospital procurement lists, and pharma distribution networks with a valid CDSCO licence.
Product Authenticity
CDSCO registration ensures your devices meet Indian safety and performance standards.
B2B Credibility
Hospitals, clinics, and distributors prefer CDSCO-registered devices from licensed traders.
5-Year Validity
MD-42 registration is valid for 5 years and renewable.
Documents Required
Keep these documents handy to ensure a smooth and fast filing process. We'll guide you at every step.
Import Export Code (IEC)
Registered office address proof
List of medical devices to be imported
Technical documentation / 510(k) / CE certificate from manufacturer
ISO 13485 certificate of foreign manufacturer
Free Sale Certificate from country of origin
Relationship agreement with foreign manufacturer
Declaration forms as required by CDSCO
Step-by-step process
Here's exactly what happens from the moment you engage us — no surprises, full transparency.
Product Classification
Classify devices under the appropriate class (A/B/C/D) per Medical Devices Rules 2017.
SUGAM Portal Registration
Register as a medical device importer on CDSCO's SUGAM online portal.
Document Compilation
Compile technical documents, manufacturer certificates, ISO certificates, and IEC.
MD-42 Application Submission
Submit the Form MD-42 application with all documents and fee payment on SUGAM.
CDSCO Review & Queries
CDSCO may raise queries on technical documents — we respond on your behalf.
Licence Issuance
MD-42 registration certificate issued — valid for 5 years from date of issue.
What you'll get
Here's everything included when you choose this service — clear deliverables, no hidden items.
MD-42 Registration Certificate
CDSCO registration authorizing import and distribution of your medical devices.
Device Classification Report
Documentation of device classification for regulatory records.
SUGAM Portal Access
Registered trader account on CDSCO's SUGAM portal.
Frequently asked questions
Quick answers to common questions about this service.
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Learn moreTalk to our experts.
Our advisors are ready to guide you through the process, answer your questions, and recommend the right plan — no obligation.