Early Access • Compliance Toolkit

Ship compliant medical devices faster

We support Indian and international manufacturers to navigate through the complex CDSCO regulatory landscape with ease. From device classification to registration, import licensing, regulatory documentation, and post-market compliance, our experts ensure your product reaches the Indian market faster and fully compliant.

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Trusted by 50+ medical device teams
Medical device and healthcare innovation

Audit-ready templates

Prebuilt QMS docs and forms to reduce setup time.

Expert coaching

Hands-on support from regulatory leads during critical milestones.

Fast approvals

Optimized submission checklists that speed up CDSCO & ISO audits.

Why Choose AR Medical Consultancy?

Faster Approvals

Average 6-month timeline to certification with our proven processes

Expert Team

15+ years combined experience in medical device regulations

End-to-End Support

Complete guidance from gap analysis to final certification

Medical device manufacturing background

Our Core Services

Comprehensive regulatory solutions for medical device manufacturers

01

Communication with CDSCO officials on your behalf

Expert preparation of documentation

  • Plant Master File (PMF)
  • Device Master File (DMF)
  • Clinical Evaluation Reports (CER)
  • Risk Management File (ISO 14971)
  • QMS documentation (ISO 13485)
02

Import License Support

We support:

  • Device categorization
  • Import license filing (Form MD-14/MD-15)
  • Query resolution
  • End-to-end document preparation
  • Customs clearance support
03

Regulatory Strategy & Gap Assessment

We evaluate your existing documentation and provide:

  • Compliance gap analysis
  • Risk-based regulatory strategy
  • Pathway planning for high-risk devices
  • Market entry assessment

04

CDSCO Medical Device Registration

We assist in obtaining:

  • Form MD-5 (Manufacturing License for Class A & B)
  • Form MD-9 (Manufacturing License for Class C & D)
  • Form MD-15 (Import License for all categories of products)
  • Form MD 12 (Test or evaluation license for manufacturing products)
  • Form D 16 (Test or evaluation license for import products)
05

CDSCO Medical Device Registration

Our services include:

  • Device classification per MDR 2017
  • Preparation and submission of regulatory dossiers
  • Guidance on fees, timelines, and compliance
  • Communication with CDSCO officials on your behalf
  • Cosmetic Registration
06

How It Works

Steps

  • Device Classification: We classify your device per MDR 2017.
  • Documentation Review: We check all documents for CDSCO compliance.
  • Application Filing: We submit your application on the CDSCO portal.
  • Query Handling: We handle all CDSCO queries until approval.
  • License Support: We guide you with labelling, vigilance, and renewals.

Key Services

Comprehensive medical device regulatory solutions

  • CDSCO Registration
  • Manufacturing License (MD/IVD)
  • Import License (MD/IVD)
  • Risk Classification
  • Technical File & Dossier Preparation
  • Post Market Surveillance Data
  • Regulatory Strategy & Gap Assessment
  • ISO 13485:2016 Implementation & Audit Support
  • Free Sale Certificate
  • Non-Conviction Certificate
  • Market Standing
  • Neutral Code
  • Form MD-42
  • Cosmetics Import Application

What Sets Us Apart

Industry Expertise

10+ years of regulatory experience

Fast Turnaround

Efficient processes ensuring rapid documentation preparation and faster approvals

End To End Support

End-to-end CDSCO compliance management

Dedicated Support

Personalized guidance throughout the entire compliance journey

Quality Assurance

100% transparency and documentation quality

Flexible Engagement

Tailored packages for startups, SMEs, and established manufacturers

About AR Medical Consultancy

Excellence in Medical Device Regulatory Compliance

Who We Are

We are a specialized regulatory consultancy helping medical device manufacturers comply with the Medical Device Rules, 2017 (MDR) and obtain the required CDSCO approvals to market their products in India. Our team includes regulatory specialists, biomedical engineers, and compliance auditors with deep experience in Indian and global medical device regulations.

10+

Years Experience

50+

Clients Served

Our Mission

To simplify the regulatory journey for manufacturers and ensure safe, compliant medical devices enter the Indian healthcare system.

Safe & Compliant Devices
Simplified Regulatory Pathways
Healthcare System Excellence
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Ready to Get Started?

Get expert guidance on your medical device regulatory compliance journey

Email

armedicalconsultancy2024@gmail.com

Response within 24 hours

WhatsApp

+91 9539193731

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Location

India

Chennai, Tamil Nadu

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