CDSCO Registration for Medical Devices

• Class A and B devices: Licenses are issued by the State Licensing Authority (SLA).
• Class C and D devices: Licenses are issued by the Central Licensing Authority (CLA).

Manufacturers must apply to the appropriate authority depending on the classification of their device, as outlined in CDSCO guidelines.

• Class A and B devices: Registration required from October 2022.
• Class C and D devices: Compulsory registration for all Class C and D devices starting October 2023.

The import license is essential for the final sale, distribution, or use of medical devices in the Indian market.

1. Class A (Low Risk): Examples include stethoscopes and bandages.
2. Class B (Low to Moderate Risk): Examples include blood pressure monitors and syringes.
3. Class C (Moderate to High Risk): Examples include orthopedic implants and catheters.
4. Class D (High Risk): Examples include pacemakers and ventilators.

This classification helps determine the regulatory path and the level of scrutiny a device will undergo.

1. Classification of Medical Device: Classifying the device as per CDSCO regulations.
2. Preparation and Submission of the Application: Preparing a detailed application with all required documentation, including regulatory certificates, clinical trial data (if available), and intended use.
3. Review by CDSCO: CDSCO reviews the application, including all supporting documents and performance data, for compliance and safety standards.
4. Approval or Rejection: If the device meets CDSCO standards, approval is granted. If not, the application may be rejected with the opportunity to address and resubmit.

1. Domestic manufacturers of medical devices and IVDs.
2. Importers and distributors of medical devices.
3. Foreign manufacturers (through an authorized Indian agent).
4. Authorized agents representing foreign manufacturers.

Each applicant type must meet specific eligibility criteria and adhere to India’s regulatory requirements.

1. Compliance with Indian Regulations: Demonstrating adherence to CDSCO’s regulations.
2. Manufacturing Facility Details: Providing information on the manufacturing site.
3. Regulatory Certificates: Certificates like the European CE, ISO 13485, or a Free Sale Certificate.
4. Labeling and Packaging Requirements: Ensuring products meet India’s specific labeling and packaging rules.
5. Registration Fees: Paying the applicable CDSCO fees.

• Market Access: Allows manufacturers to sell and distribute products in India’s vast healthcare market.
• Brand Recognition: Enhances credibility by meeting India’s stringent regulatory standards.
• Regulatory Compliance: Ensures full compliance with Indian health and safety laws, including Good Manufacturing Practices (GMP).
• Competitive Advantage: Opens the door to government and private tenders and provides a clear market edge.

1. Complex Documentation: The application process involves extensive documentation, which can be difficult for new applicants to organize.
2. Strict Regulatory Requirements: Adhering to CDSCO’s regulations requires a comprehensive understanding of Indian healthcare laws.
3. Time and Cost Constraints: Registration can be time-consuming and may incur significant costs, especially for smaller manufacturers.