Regulatory Approval Process for Medical Devices in India 2026

The regulatory approval process for medical devices in India is governed by the Medical Devices Rules (MDR), 2017, under the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare. Below is a concise overview of the process:

1. Device Classification

• Medical devices are classified into four risk-based categories per MDR 2017:
• Class A: Low risk (e.g., thermometers, bandages)
• Class B: Low-moderate risk (e.g., hypodermic needles)
• Class C: Moderate-high risk (e.g., ventilators)
• Class D: High risk (e.g., pacemakers)
• Classification aligns with global standards (e.g., IMDRF).

2. Registration on SUGAM Portal

• Manufacturers and importers register on the SUGAM portal (www.cdscoonline.gov.in) to obtain credentials and submit applications.

3. Quality Management System (QMS)

• Class C and D devices require ISO 13485 compliance.
• QMS documentation (design controls, risk management) is verified by a notified body or auditor.

4. Technical Documentation

• Submit a dossier including:
• Device description and intended use
• Design and manufacturing details
• Clinical evaluation data (mandatory for Class C/D)
• Risk analysis
• Labeling and Instructions for Use
• Stability data
• For imported devices, CE marking or US FDA approval may support but isn’t sufficient alone.

5. Application Process

• Manufacturers:
• Class A/B: Apply for a manufacturing license (Form MD-5) via State Licensing Authority.
• Class C/D: Apply to CDSCO for a license (Form MD-9).
• Importers:
• Apply for an Import License (Form MD-15) via CDSCO.
• Submit Free Sale Certificate, ISO 13485, and appoint an Authorized Indian Agent.

6. Clinical Evaluation and Testing

• Class C/D: Provide clinical data; global data may be accepted if India-specific data is unavailable.
• Devices may require testing at CDSCO-approved or BIS-accredited labs.

7. License Issuance

• Upon review, CDSCO or State Authority issues:
• Manufacturing License (MD-5 for A/B, MD-9 for C/D)
• Import License (MD-15)
• Licenses are valid for 5 years.

8. Post-Market Surveillance

• Report adverse events and conduct surveillance as per MDR 2017.
• CDSCO may perform inspections.

Key Notes

• Non-Notified Devices: Unregulated but may require Voluntary Registration until notified.
• BIS Certification: Required for certain devices.
• Timeline: 3–6 months for Class A/B; 6–12 months for Class C/D.
• Challenges: Complex documentation, limited testing facilities, evolving regulations.

Tips

• Engage a local regulatory consultant.
• Align with ISO 13485 early.
• Monitor CDSCO updates via www.cdsco.gov.in.

For detailed guidance, consult the CDSCO website or a regulatory expert.

DELHI CDSCO

FOR ANY QURRIES DIRECT CONTACT US

SATISH MEHRA

VSD CONSULTANT

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