Indian MDR-2017 (CDSCO)

Ensures safety and quality of medical devices in India through CDSCO regulations.

Indian MDR-2017 (CDSCO)

The Indian Medical Device Rules, 2017 (MDR), enforced by the Central Drugs Standard Control Organization (CDSCO), establish a mandatory regulatory framework for the manufacturing, import, distribution, and sale of medical devices in India. This ensures the safety, efficacy, and quality of devices, aligning them with global standards.

Mandatory Licensing:

A CDSCO Medical Device Manufacturing License is required to manufacture devices legally in India.

Risk-Based Classification:

Devices are classified as Class A, B, C, or D, based on risk, ensuring proportionate regulatory oversight.

Global Alignment:

Compliance with MDR-2017 facilitates access to both domestic and international markets.

Enhanced Safety:

Ensures only high-quality, tested devices reach patients, boosting trust and reliability.

Post-Market Surveillance:

Promotes continuous monitoring and reporting for improved product performance.

HL Associate's Expertise

How We Assist with CDSCO License Applications

Navigating the licensing process for medical device manufacturing under CDSCO can be complex, but we make it seamless. Here’s how we support you:

Device Classification

Determine your device's risk category (Class A, B, C, or D) and develop a tailored regulatory roadmap.

SUGAM Portal Assistance

Ensure accurate and timely online registration and submission.

License Application Support

Provide comprehensive guidance for the CDSCO Medical Device Manufacturing License application process.

Documentation & Compliance

Assist with technical documentation, QMS preparation, and post-market surveillance for ongoing compliance.

Take the First Step

Stay compliant and competitive in the medical device market.
📞 Book a free consultation today and let our experts guide you through the regulatory process with ease!

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Our Clients Who Trust Our Expertise

We’re proud to work with clients who value quality, precision, and a commitment to excellence. Our clients in the medical device industry rely on us to guide them through complex regulatory requirements, and their trust is our greatest reward. Here’s to partnerships built on success!