Medical Device Regulatory Services in India

Bringing a medical device to the Indian market today means staying ahead of more than just paperwork, it means responding to real-time CDSCO updates, adapting to expanding device notifications, and understanding technical documentation that changes with each class and format. Whether you're registering a diagnostic kit, a connected wearable, an orthopedic implant, a drug eluting stent or a digital SaMD , India’s regulatory journey demands more than a checklist. At DDReg, we provide the clarity, speed, and local authority alignment you need to move from application to approval without losing time or traction.

At DDReg, we provide strategic, end-to-end regulatory support from device classification and predicate device identification in India, to securing your medical device import license, filing through SUGAM , and supporting your lifecycle obligations post-approval..

India regulates medical devices under the Medical Device Rules (MDR), 2017, enforced by CDSCO, with updates released via notifications and guidance documents. Devices are categorized based on risk class as follows:

All notified devices, whether imported, manufactured, or distributed—must undergo medical device product registration before entering the Indian market.

Approval Process of Class A, B, C & D Medical Devices in India

• + Device Classification & Regulatory Strategy
  • Determine device class (A–D) based on intended use and risk profile
  • Evaluate CDSCO’s notified list to confirm if your product requires registration
  • Support for predicate device identification in India (essential for equivalence claim)
  • Advice on applicable IS/IEC/ISO technical standards
• + CDSCO Medical Device Registration & Import Licensing
  • Preparation and submission of device registration dossiers via SUGAM portal
  • End-to-end support for:

    • Clinical data mapping, IFU review, test reports, labeling validation
    • Liaison with regulatory authorities for queries, inspections, or clarifications
• + Manufacturing Site Licensing & Documentation Support
  • Advisory on setting up or expanding facilities under Form MD-5 or MD-7
  • Technical writing and formatting of:

    • Device Master File (DMF)
    • Plant Master File (PMF)
  • Support for ISO 13485 alignment, QMS readiness, and site audits
• + Indian Authorized Agent (IAA) Representation
  • Regulatory representation for foreign manufacturers with no local office
  • Handling CDSCO correspondence, adverse event reporting, license renewals
  • Compliance with conditions of import license holders
• + Labeling, IFU & Packaging Compliance
  • Verification against Medical Device Labelling Rules under MDR, 2017
  • Guidance for:

    • UDI compliance
    • Manufacturer/importer declarations
    • SaMD-specific display elements
    • Dual language requirements (English + regional)
• + Post-Market Surveillance & Regulatory Maintenance
  • Implementation of materiovigilance systems
  • Assistance with complaint handling, recalls, and adverse event documentation
  • Support for license variations, renewals, scope extensions, and name changes
  • Monitoring of CDSCO circulars, notifications, and risk alerts

CDSCO has strict controls over imported medical devices. Whether you’re an EU, US, or APAC-based manufacturer, DDReg enables smooth entry into India through:

• Indian Authorized Agent appointment and coordination
• Preparation of import license documentation ( dossier , FSC, QMS, test reports)
• Support for legal metrology, artwork revisions, shelf-life validation
• Engagement with CDSCO for product classification queries and predicate approvals
• Importer compliance and port clearance advisory

We assist across the key milestones:

• Decade-long experience with Indian and global medical device filings
• Expertise in both Form MD-14/15 (Import) and MD-3/5 (Manufacture)
• Category-specific capabilities: from SaMD to combination devices
• Comprehensive dossier preparation for Class C & D devices, aligned with GHTF and IMDRF
• End-to-end support: classification → SUGAM submission → approval → lifecycle management

We don’t just manage submissions—we partner with you to accelerate compliant access to one of the fastest-growing biologics markets in the world.