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CDSCO MDR APPROVAL

CDSCO MDR APPROVAL
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CDSCO MDR Approval

Ensure Compliance for Medical Devices in India

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, is the national regulatory authority responsible for the approval, regulation, and quality control of medical devices and in-vitro diagnostic (IVD) products in India.

To ensure patient safety and product quality, the Government of India has brought medical devices under the Medical Device Rules (MDR) 2017. Manufacturers, importers, and distributors must obtain CDSCO MDR Approval before selling medical devices in the Indian market.

What is CDSCO MDR Approval?

CDSCO MDR Approval is a license or registration certificate granted to medical device manufacturers or importers after verifying compliance with:

  • Medical Device Rules (MDR) 2017
  • Quality standards such as ISO 13485
  • Product safety, efficacy, and risk classification

Medical devices in India are classified as Class A, B, C, or D based on their risk level, and approval requirements vary accordingly.

Devices Covered Under CDSCO MDR Approval

  • Surgical instruments
  • Diagnostic kits & IVDs
  • Cardiac stents & implants
  • Orthopedic implants
  • Syringes, needles, and catheters
  • Dental products
  • Imaging devices (X-ray, MRI, CT scan)
  • Wound care & disposable devices

(The list expands as per CDSCO’s updated notifications.)

Our CDSCO MDR Approval Services

We provide end-to-end consulting and compliance support for medical device approvals in India:

  • Device Classification & Regulatory Pathway Guidance
  • Application Preparation & Submission on SUGAM Portal
  • Clinical Evaluation Report (CER) Support
  • ISO 13485 & QMS Compliance Consulting
  • Coordination with Notified Bodies & CDSCO Authorities
  • Import License & Manufacturing License Assistance
  • Post-Approval Compliance & Renewals

Benefits of CDSCO MDR Approval

  • Legal Compliance – Mandatory to sell devices in India.
  • Patient Safety – Ensures quality and efficacy of products.
  • Market Access – Approval opens doors to the Indian market.
  • Global Recognition – Enhances credibility and trust.
  • Competitive Edge – Builds brand value among healthcare providers.

Why Choose Us?

  • Experienced Regulatory Experts with deep knowledge of MDR rules.
  • End-to-End Support – From classification to approval.
  • Fast & Hassle-Free Process with complete documentation support.
  • Trusted by Leading Manufacturers & Importers across industries.

Get your CDSCO MDR Approval with expert guidance.
We help you achieve regulatory compliance and ensure a smooth market entry for your medical devices in India.

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