Indian MDR 2017 (CDSCO)

The Indian Medical Device Rules (MDR) 2017, regulated by the Central Drugs Standard Control Organization (CDSCO), govern the manufacture, import, sale, and distribution of medical devices in India. These rules introduce a risk-based regulatory framework to ensure the safety, quality, and performance of medical devices.

Compliance with Indian MDR 2017 is mandatory for medical device manufacturers and importers operating in the Indian market. Chitransh Groups Pvt. Ltd. provides end-to-end regulatory consulting services to support organizations throughout the CDSCO approval process.

Our Indian MDR 2017 Services

Medical device classification as per Indian MDR 2017
Regulatory strategy and compliance planning
Preparation and submission of CDSCO applications
Manufacturing and import license support
Coordination with CDSCO and State Licensing Authorities
Post-approval compliance and lifecycle regulatory support

Benefits of MDR 2017 Compliance

Legal market access in India
Improved regulatory compliance and traceability
Enhanced product safety and quality assurance
Smoother interactions with CDSCO authorities
Stronger foundation for global regulatory expansion

Why Choose Chitransh Groups?

Our regulatory professionals have extensive hands-on experience with Indian medical device regulations and CDSCO processes. We focus on accurate documentation, practical compliance solutions, and timely approvals to help clients confidently enter and sustain their presence in the Indian medical device market.