Medical device registration: The registration of medical devices in India is regulated by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules (MDR), 2017, effective since January 1, 2018. Below is a concise guide to the medical device registration process in India.
1. Determine Device Classification
- Medical devices are classified into four risk categories per MDR 2017:
- Class A: Low risk (e.g., bandages, thermometers)
- 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 is based on intended use and risk, aligned with global standards like IMDRF.
2. Register on SUGAM Portal
- All applicants (manufacturers and importers) must register on the CDSCO’s SUGAM portal (www.cdscoonline.gov.in) to obtain login credentials for submitting applications.
3. Prepare Documentation
- Quality Management System (QMS):
- Class C and D devices require ISO 13485 compliance, verified by a notified body.
- Submit QMS documentation (e.g., design controls, risk management).
- Technical Dossier:
- Device description and intended use
- Design and manufacturing details
- Clinical evaluation data (mandatory for Class C/D; global data may be accepted)
- Risk analysis and mitigation
- Labeling and Instructions for Use (IFU)
- Stability and shelf-life data
- For imported devices: Free Sale Certificate, CE marking, or US FDA approval (supporting, not sufficient alone).
4. Submit Application
- Manufacturers:
- Class A/B: Apply for a manufacturing license (Form MD-5) through the State Licensing Authority via the SUGAM portal.
- Class C/D: Apply to CDSCO for a manufacturing license (Form MD-9).
- Importers:
- Apply for an Import License (Form MD-15) via CDSCO.
- Appoint an Authorized Indian Agent and submit additional documents like ISO 13485 certification.
5. Testing and Clinical Evaluation
- Devices may require testing at CDSCO-approved or BIS-accredited laboratories to ensure compliance with Indian standards.
- For Class C/D, clinical evaluation data is mandatory to demonstrate safety and efficacy.
6. License Issuance
- After review, licenses are issued:
- Manufacturing License: Form MD-5 (Class A/B) or MD-9 (Class C/D)
- Import License: Form MD-15
- Licenses are valid for 5 years and renewable.
7. Post-Market Requirements
- Conduct post-market surveillance and report adverse events to CDSCO.
- Comply with periodic inspections by regulatory authorities.
Additional Considerations
- Non-Notified Devices: Devices not listed as notified by CDSCO are currently unregulated but may require Voluntary Registration until officially notified.
- BIS Certification: Mandatory for certain devices to meet Indian quality standards.
- Labeling: Must include device name, manufacturer details, batch number, and expiry date per MDR 2017.
- Timeline: Approximately 3–6 months for Class A/B; 6–12 months for Class C/D.
Tips for Successful Registration
- Engage a local regulatory consultant to navigate CDSCO processes.
- Ensure early compliance with ISO 13485 and Indian standards.
- Monitor updates on the CDSCO website (www.cdsco.gov.in).
For further details or specific requirements, visit the CDSCO website or consult a regulatory expert familiar with MDR 2017.
Best Delhi Medical Device Registration consultant
Satish mehra(Regulatory Consultant)
+91-8920964801 (whatsapp or call us)