On April 24, 2025, Qualtech hosted a webinar focused on navigating the regulatory landscape for medical devices in India. The session was presented by Mr. Anil Chaudhari, Founder and CEO of Operon Strategist, and Ms. Lakshmi Ranjith, Manager of Regulatory Affairs of Operon Strategist. Together, they provided a detailed overview of India’s regulatory system, including the roles of CDSCO and state licensing authorities, the classification of medical devices by risk level, the registration process, and best practices for compliance. The following summary highlights the key insights and essential regulatory requirements, offering valuable guidance for medical device companies seeking to enter or expand in the India market.
Key Regulatory Authorities
- Central Drugs Standard Control Organization (CDSCO) is the primary authority for medical device regulation under the Ministry of Health and Family Welfare.
- State Licensing Authorities manage the licensing of lower-risk device manufacturing (Class A and B) within their respective jurisdictions.
- Additional Bodies such as the Bureau of Indian Standards (BIS) and National Accreditation Board for Testing and Calibration Laboratories (NABL) are also involved depending on the device type.
Medical Device Classification in India
Devices are classified based on risk level into four categories:
| Class | Risk Level | Examples |
|---|---|---|
| A | Low | Bandages, Thermometers |
| B | Low to Moderate | Surgical Instruments, Oxygen Concentrators |
| C | Moderate to High | Dialysis Machines, CT Scanners |
| D | High (Critical) | Pacemakers, Heart Valves |
- Class A and B: Regulated primarily by State Licensing Authorities and Notified Bodies.
- Class C and D: Regulated centrally by CDSCO with rigorous documentation and clinical evaluation requirements.
Registration Process
All applications are submitted electronically through India's national portals:
General Steps:
- Portal Account Creation: NSWS (National Single Window System) and CDSCO’s SUGAM portal.
- Application Submission: Via prescribed forms depending on device class.
- Documentation Preparation: Including product details, ISO 13485 certification, clinical data (for higher-risk devices), manufacturing licenses, and labeling.
- Regulatory Review:
- For Class A and B: Inspections managed by Notified Bodies.
- For Class C and D: Direct evaluation by CDSCO, often involving expert review and clinical trial data.
- Approval or Query Handling: Response to regulatory queries is critical to expedite approval.
Estimated Approval Timelines:
| Class | Estimated Processing Time |
|---|---|
| A | 3–6 months |
| B | 6–9 months |
| C | 9–12 months |
| D | 12–18 months |
Import License Requirements
- For imported devices:
- A local Authorized Indian Representative (AIR) must be appointed.
- Required documents include:
- Free Sale Certificate (Country of origin and USA, EU or one of the GHTF countries)
- ISO 13485, CE Certification, or USFDA Approval
- Site Master File and Device Master File
- All documents must be in English.
- Import license approval typically requires 6 to 9 months.
- Licenses must be renewed every five years; endorsements require periodic updates.
Common Challenges Identified
- Long approval timelines due to procedural volume.
- Mandatory local clinical trials for high-risk devices with no FDA, MDR or approval from any GHTF countries.
- Mandatory local representation for foreign manufacturers.
Recommended Best Practices
- Engage in early regulatory planning and seek CDSCO's classification advice.
- Ensure complete and well-organized documentation.
- Appoint an experienced local regulatory agent or representative.
- Maintain compliance with both Indian and international standards (e.g., BIS, ISO 13485).
- Monitor regulatory updates and maintain flexibility to adjust processes.
- Optimize clinical trial planning in accordance with Indian Good Clinical Practice (GCP) standards.
Stay Compliant with Confidence — Partner with Qualtech
The webinar emphasized the importance of understanding and complying with India's medical device regulations. With insights into CDSCO registration processes, risk-based classifications, licensing requirements, and practical challenges, it became clear that strategic planning and regulatory expertise are essential for successful market entry.
Contact us today to learn how we can help you streamline your CDSCO registration process and accelerate your success in the India market.