CDSCO Registration for Medical Devices

Any manufacturer, importer, or marketer planning to sell medical devices in India must comply with CDSCO registration and licensing requirements as per the Medical Devices Rules (MDR), 2017.

What is CDSCO Registration for Medical Devices?

CDSCO registration is a mandatory regulatory approval required for medical devices notified under MDR 2017. Central Drugs Standard Control Organization (CDSCO) ensures that medical devices sold in India meet prescribed quality, safety and performance standards, that’s why CDSCO Registration is required for all the manufacturers or importers in India.

The registration of medical devices applies to both:

• Indian manufacturers
• Foreign manufacturers importing medical devices into India

Only CDSCO registered medical devices are allowed to manufacture, import or sell in India.

Types of CDSCO Licenses for Medical Devices

Depending on the nature of the business, different CDSCO licenses and registrations apply:

1. CDSCO Medical Device Manufacturing License

2. CDSCO Import License

3. Establishment Registration and Device Listing

CDSCO Online Registration Process (SUGAM Portal)

All applications are submitted through the CDSCO online registration system, commonly known as the CDSCO SUGAM portal.

Basic Steps:

1. Gap Analysis & Planning – Review of product list, formulation, and labeling compliance.
2. Document Preparation – Drafting and compilation of applications.
3. Technical File Compilation – Product composition, labels, free sale certificate, test reports.
4. Submission on CDSCO SUGAM Portal – Filing of application with supporting documents.
5. Coordination with CDSCO – Reply to queries/deficiencies until approval.
6. Grant of Registration Certificate – Valid for 3 years.

CDSCO Registration Fees

CDSCO registration fees vary depending on:

• Type of license (Import / Manufacturing)
• Risk classification (Class A, B, C, D)
• Number of devices

Fees are payable online during the CDSCO registration process through the SUGAM portal.

Medical Device Registration Process in India

The medical device registration process typically includes:

• Device classification as per MDR 2017
• Technical documentation preparation
• ISO 13485 certification
• Establishment registration and device listing
• Product evaluation and approval
• Issuance of CDSCO registration certificate

This applies to all medical equipment registration and notified medical devices.

Voluntary vs Mandatory CDSCO Registration

Earlier, CDSCO voluntary registration was permitted for certain devices. However, with phased notifications, most medical devices now fall under mandatory CDSCO registration of medical devices.

Always verify whether your product is notified in the medical device register maintained by CDSCO.

How to Check CDSCO Medical Device Registration Status

Businesses can check medical device registration status directly on the CDSCO SUGAM portal using:

• Application number
• Establishment details
• Device listing reference

Once approved, the product is officially recognized as a CDSCO registered medical device.

CDSCO vs FDA Medical Device Registration

Many manufacturers compare drug establishment registration FDA with Indian requirements. While both aim to ensure safety and quality:

• CDSCO focuses on MDR 2017 compliance
• FDA follows US FDA 21 CFR regulations

A separate blog or product registration guidelines CDSCO Slideshare-style presentation can help understand these differences clearly.

Why Hire a CDSCO License Consultant?

The CDSCO regulatory framework is technical and documentation-heavy. A professional CDSCO license consultant helps with:

• Device classification
• Gap analysis
• Documentation & submission
• Faster approval and compliance

This reduces delays, rejections and compliance risks.

Conclusion

CDSCO medical devices registration is a critical step for market entry in India. Whether it’s medical device establishment registration, CDSCO import license, or manufacturing license, compliance with CDSCO regulations is non-negotiable.

With the right guidance, proper documentation, and expert support, the medical device registration process can be smooth and hassle-free.