Trusted Regulatory Compliance Partner for Medical Device Manufacturers, Importers, Hospitals & Laboratories Learn More
Precision-Engineered Regulatory Infrastructure

Engineering Regulatory Compliance for India's Healthcare Industry

Helping manufacturers, importers, hospitals and laboratories obtain regulatory approvals faster with complete transparency.

Zero-Bribe Policy
Transparent Digital Tracking
Technical Experts
Regulatory compliance infrastructure representation

Core Regulatory Services

Streamlined pathways for critical healthcare approvals.

CDSCO Regulatory & MDR 2017 Compliance

  • CDSCO Sugam Portal Onboarding & AIR setup
  • MD-15 Import License Application
  • Manufacturing Site Licensing (Form MD-5/MD-9)
  • MDR 2017 Risk-Class Audits & Technical File compilation

Quality Management Systems (QMS) & Lab Accreditation

  • ISO 13485:2016 QMS Implementation
  • Internal Audits & SOP Layouts
  • NABL ISO/IEC 17025 Setup
  • Measurement Uncertainty (MU) calculations

AERB eLORA & Radiation Safety Compliance

  • AERB eLORA Portal Onboarding
  • Site Shielding Layout Plan Validation
  • Procurement Permission & Operating License Setup
  • RSO Certification

MoEFCC NOC for Import of Pre-Owned Medical Devices (Basel No. B1110)

  • MoEFCC B1110 Import Permission
  • Technical Dossier & End-of-Life Disposal Undertaking
  • Chartered Engineer Documentation & Customs Alignment
  • High-Value Equipment Eligibility Audits

EPR Compliance for Pre-Owned Medical Equipment (E-Waste Rules, 2022)

  • CPCB E-Waste Portal Registration
  • EPR Obligation Planning
  • Refurbisher Registration & Traceability
  • Environmental Record Keeping & End-of-Life Disposal
Who We Are

India's Trusted Regulatory Infrastructure Partner

Alethia Compliance simplifies complex regulatory processes for medical device manufacturers, importers, hospitals, and testing laboratories. We act as your compliance engineering backbone, securing critical government approvals with speed, precision, and complete digital transparency.

By combining deep technical expertise with a modern digital tracking portal, we eliminate the bottlenecks, opacity, and delays traditionally associated with medical regulatory clearances in India.

12,000+ Approvals Secured
15 Days Avg. Turnaround
500+ Technical Experts

Zero-Bribe Integrity

Our strict governance policies ensure all applications are processed on merit, providing absolute corporate safety.

Technical Precision

We compile and audit Device Master Files (DMF) and Plant Master Files (PMF) to eliminate rejection risks.

Digital Transparency

Track dossier stages, fee payments, and queries in real-time through our secure client compliance portal.

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How can we help you with CDSCO, QMS, or AERB approvals today?