Medical Device Registration

Close up of medical form on white desk with medical tools in clinical setting, copy space

Medical Device Registration

Comprehensive CDSCO Registration & Compliance Services

At Isha’s GMP Consultancy, we provide end-to-end regulatory support for medical device and in-vitro diagnostic (IVD) registration with the Central Drugs Standard Control Organization (CDSCO) in India. Our expert team ensures smooth market entry, regulatory compliance, and faster approvals for manufacturers and importers.

Medical Device Classification in India (Risk-Based Approach)

Medical devices and IVDs are classified based on their intended use and associated risk:

  • Class A – Low Risk (e.g., Thermometers, Surgical Dressings)
  • Class B – Low-Moderate Risk (e.g., Hypodermic Needles, Diagnostic X-ray)
  • Class C – Moderate-High Risk (e.g., Blood Bags, Dialysis Machines)
  • Class D – High Risk (e.g., Heart Valves, Implantable Pacemakers)
CDSCO Registration Process for Imported Medical Devices
 

Foreign manufacturers must register their medical devices with CDSCO before importing them into India. The process includes:

Step 1: Device Classification & Regulatory Assessment

  • Identify classification under CDSCO guidelines.
  • Confirm if registration is required based on risk category.
Step 2: Appointment of Authorized Indian Agent (AIA)
  • Foreign manufacturers must appoint an AIA to handle regulatory filings.
  • Isha’s GMP acts as an Indian Authorized Agent (IAA) to facilitate approvals.
Step 3: Preparation & Submission of Registration Dossier
  • Compile Design Dossier – Technical documentation, safety & performance data.
  • Submit Form 41 – Medical Device Registration Certificate.
  • Submit Form 10 – Import License Application.
Step 4: CDSCO Review & Query Resolution
  • CDSCO reviews submitted documents and may raise queries.
  • Our team ensures a smooth response to all CDSCO queries for faster approvals.
Step 5: Grant of Medical Device Registration & Import License
  • Upon CDSCO approval, Form 41 (Registration Certificate) and Form 10 (Import License) are issued.
  • You can now legally import, market, and distribute medical devices in India.
Our Medical Device Regulatory Services in India
  • Medical Device Classification & Categorization
  • Regulatory Strategy & Registration Dossier Preparation
  • Indian Authorized Agent Services for Foreign Manufacturers
  • CDSCO Submission, Query Handling & Approval Support
  • Clinical Trial Approvals & Testing Requirements
  • Import, Manufacturing, & Distribution Compliance
  • Post-Market Surveillance & Regulatory Maintenance
Why Choose Isha’s GMP Consultancy?
  • Regulatory Experts – Decades of experience in CDSCO compliance & approvals.
  • Faster Market Entry – Streamlined process for quick registration & licensing.
  • End-to-End Solutions – From classification to post-market surveillance.
  • Trusted Partner – Authorized Indian Agent Services for foreign manufacturers.
Contact us today for seamless CDSCO registration & regulatory approvals in India!

Medical Device