India Medical Device Registration

Planning to bring your medical device to India?

Navigating the medical device registration in India can feel overwhelming, especially with the frequent updates in regulations. That’s where we come in.

Here’s what you need to know:

• Medical devices are regulated under the Medical Devices Rules, 2017
• Registration/licensing is mandatory before market entry
• Risk-based classification (Class A–D) determines the approval pathway
• Applications are submitted through the CDSCO online SUGAM portal

Who Regulates Medical Devices in India?

In India, medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO). It’s the main authority under the Ministry of Health and Family Welfare, ensuring all medical products—whether manufactured locally or imported—are safe, effective, and high-quality.

The Legal Framework

India regulates medical devices under the Medical Devices Rules, 2017, which have been regularly updated to keep pace with global practices. These rules classify devices based on risk to ensure proper oversight.

Device Classification in India

Class A – Low risk (e.g., surgical dressings)

Class B – Low to moderate risk (e.g., infusion pumps)

Class C – Moderate to high risk (e.g., bone fixation plates)

Class D – High risk (e.g., heart valves, implants)

What’s New ?

medical device registration in India has transitioned to a fully digital process. The CDSCO medical device registration system has been upgraded to make things easier, but the regulatory expectations have also increased.

Here’s what’s important:

Import licenses (MD-14/MD-15) are now mandatory for Class A (Sterile/Measuring), B, C, and D devices.

Applications must be submitted through the CDSCO SUGAM portal with complete and compliant documentation

Key Documents Required

To apply for medical device approval in India, make sure you have the following:

1. MD-14 Application Form
2. TR6 Challan (fee receipt)
3. Power of Attorney
4. Device Master File (DMF)
5. Plant Master File (PMF)
6. ISO 13485 Certification
7. CE Certificate or equivalent approval
8. Free Sale Certificate
9. Declaration of Conformity
10. Post-Market Surveillance reports
11. Evidence of marketability in GHTF countries (if applicable)

 All documents must be in English.

How Long Does the CDSCO Device Registration Process Take?

Typically, you can expect the medical device registration India process to take 6 to 9 months, depending on your product class and documentation.

License Validity & Renewals

• Import License (MD-15) is valid for 5 years
• Renewal should be done at least 3 -6 months before expiry

Applying early ensures business continuity and avoids compliance issues.

Who Can Apply?

Only an Indian entity can apply for CDSCO licensing. If you’re a foreign manufacturer, you’ll need a trusted partner in India—either:

• An Authorized Indian Representative (AIR), or
• A local importer or distributor

This representative will handle the entire process, from document submission to communication with CDSCO.

Need Help with Medical Device Registration in India?

At OMC Medical Limited, we specialize in helping companies like yours get through the CDSCO medical device registration process smoothly and efficiently.

Here’s how we support you:

• Act as your Authorized Representative in India
• Help classify your device correctly under India medical device regulations
• Prepare and submit all technical documentation
• Apply for MD-14 and MD-15 licenses
• Handle renewals and post-approval requirements

Why Choose OMC Medical?

✅ Friendly and experienced regulatory experts
✅ Affordable, end-to-end service
✅ On-time project delivery
✅ Global regulatory knowledge with local insight

? Let’s make India your next market. Contact us for a free consultation: sales@omcmedical.com and reach out to our office in India.