Setting up manufacturing for Class C and Class D medical devices in India requires strict regulatory approval under the Medical Device Rules, 2017.
To legally manufacture high-risk medical devices, you must obtain a CDSCO Manufacturing License in Form MD-9, which is granted after applying through Form MD-7.
At ELT Corporate, we provide complete consulting support as a trusted CDSCO MD-9 Manufacturing License Consultant, ensuring your application is compliant, technically strong, and processed without unnecessary delays.
The MD-9 License is issued by the Central Licensing Authority (CDSCO) for:
Class C (Moderate-High Risk) Devices
Class D (High Risk) Devices
This license allows manufacturers to:
Without MD-9 approval, manufacturing of such devices is not permitted under MDR 2017.
You need an MD-9 Manufacturing License if you are:
Medical device manufacturer (Class C or D)
Startup entering medical device manufacturing
Importer shifting to local manufacturing
OEM / contract manufacturer
Company planning to scale production in India
The process for obtaining MD-9 license involves:
Identify correct device class under MDR 2017
Prepare complete regulatory file:
Submit application through CDSCO SUGAM portal
Detailed evaluation of device safety and performance
Inspection of manufacturing facility by authority
Approval issued after compliance verification
A strong documentation set is critical for approval:
Poor documentation is the #1 reason for CDSCO rejection
As per MDR 2017:
Additional fees may apply based on the number of devices and manufacturing sites.
Timelines depend on:
Many applications fail due to avoidable mistakes:
Most rejections are due to documentation gaps, not product quality
We are not just consultants — we are execution partners.
We ensure your application is aligned with current CDSCO expectations
If you are planning to manufacture Class C or Class D medical devices in India, expert guidance is critical to avoid delays and rejections.
Call / WhatsApp: +91 98919 98002
Get professional support from a trusted CDSCO MD-9 Manufacturing License Consultant and ensure faster, compliant approvals.
