CDSCO Medical Devices
Medical Device Registration as per CDSCO Regulations
Helped many global brands achieve compliance
End-to-end assistance for registering medical devices in compliance with India's medical device regulations.
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Why Choose JR Compliance?
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Why Choose CDSCO Medical Devices?
End-to-end assistance for registering medical devices in compliance with India's medical device regulations.
JR Compliance's regulatory experts specialize in navigating the complex Medical Device Rules 2017 and Drug & Cosmetics Act requirements for your medical devices. We provide complete support from device classification and risk assessment to clinical evidence compilation and SUGAM portal submissions. Our team coordinates with notified bodies, manages comprehensive technical documentation, and handles all communication with CDSCO authorities on your behalf. We ensure your products meet stringent safety and performance standards while accelerating your time-to-market. Our consultants guide you through every stage of the approval process, addressing queries promptly and maintaining compliance. Post-registration, we offer vigilance reporting support, license renewal services, and ongoing compliance management.
Legal market access for medical devices
Patient safety compliance
Market credibility with healthcare providers
Competitive advantage in medical sector
Access to hospital & clinic networks
Government tender eligibility
MDR 2017 compliance
Expert regulatory guidance
Streamlined approval process
Simple Step-by-Step Process
Product Classification
Determine device classification (A, B, C, D) under MDR 2017.
Document Preparation
Compile technical file, clinical data, and regulatory documents.
SUGAM Portal Registration
Create account and submit application on CDSCO portal.
Application Review
CDSCO reviews application and may request additional information.
Plant Inspection
Facility inspection for Class C and D devices (if applicable).
Registration Grant
Receive CDSCO registration certificate for your device.
Required Documents
Frequently Asked Questions
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CDSCO Medical Devices