The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health & Family Welfare, is India’s principal regulatory authority for the registration and regulation of medical devices. The CDSCO ensures that medical devices available in the market are safe and effective for use by the intended population.

Medical devices are classified into four categories—A, B, C, and D—based on the level of risk, ranging from low to high. This classification determines the regulatory requirements, with higher-risk devices undergoing more stringent scrutiny.

Recent Regulatory Changes

According to the Medical Device Rules, 2017, as amended by GSR 102(E) on February 11, 2020, effective from October 1, 2023, the medical devices in classes C and D (higher-risk categories) now require mandatory licensing. This mandate aims to improve the quality and safety of medical devices in healthcare, ensuring better protection for patients and users.

Scope of Class C & D Non-Notified Medical Devices

Class C and D medical devices are classified as moderate to high risk (Class C) and high risk (Class D). If they fail, these devices are critical for sustaining or supporting life or pose significant risks. These devices are regulated under the oversight of the Central Licensing Authority (CLA) in India and are subject to rigorous scrutiny.

Inspection and Compliance Requirements

Medical Device Officers (MDOs) from the Central Licensing Authority (CLA) are responsible for inspecting manufacturing facilities to ensure compliance with the Fifth Schedule of the MDR 2017. These inspections must occur within 60 days of the application submission date.

Procedure to Meet the CDSCO License Mandate for Class C & D Medical Devices

To comply with the CDSCO license mandate, follow these steps:

Step Procedure Details
1. Device Classification Classify medical devices into Class C or D based on risk level: Class C (Moderate to High Risk) & Class D (High Risk).
2. Engage Indian Authorized Agent (IAA) Required for foreign manufacturers. IAAs handle regulatory compliance and communication with CDSCO. Not required for Indian manufacturers.
3. Application Submission Submit Form MD-7 via the CDSCO SUGAM Portal for a manufacturing/import license.
4. Device Master File (DMF) Prepare DMF documentation, including device description, manufacturing details, labeling, and packaging.
5. Technical Documentation Submit risk analysis, performance data, and safety reports to comply with regulatory requirements.
6. Quality Management System (QMS) Provide ISO 13485 Certification and Site Master File to demonstrate adherence to international QMS standards.
7. Regulatory Certificates Submit Free Sale Certificate (FSC), CE Certificate, or US FDA Clearance (for imported devices).
8. Clinical Evaluation Report (CER) Provide clinical evidence of device safety and performance, which may include clinical trials or literature reviews.
9. Biocompatibility & Sterilization Reports Provide data on biocompatibility and sterilization processes to ensure material safety and sterility.
10. Inspection by MDO The inspection of the manufacturing site by MDO must occur within 60 days of application submission.
11. Licensing Licensing by CDSCO must be completed before the October 1, 2023, deadline to ensure compliance.
12. Registration on SUGAM Portal Register and submit all required documents on the CDSCO SUGAM Portal.
13. Fees Payment Pay the application processing fees as per CDSCO’s fee schedule.
14. Compliance and Approval Ensure all documentation meets CDSCO standards and complete the review and approval process within 60 days.

 

Documentation Required for Registration and Licensing

To register and license Class C and D medical devices under CDSCO, a comprehensive set of documents is required:

  1. Application Form:
    • Form MD-7: Application form for obtaining a manufacturing license for Class C or Class D devices.
    • Form MD-8: Application form for obtaining a manufacturing loan license for Class C or Class D devices.
    • Form MD-14: Application form for obtaining an import license to import medical devices.
  2. Device Master File (DMF):
    • Device Description: Details of the device, including its intended use, indications, and instructions for use.
    • Design and Manufacturing Information: Information on design, components, and manufacturing process.
    • Labeling and Packaging: Copies of labels and packaging used in the Indian market.
  3. Technical Documentation:
    • Risk Analysis: Risk assessment, identifying potential hazards and mitigation measures.
    • Performance Data: Clinical data or performance studies supporting safety and efficacy.
    • Electrical Safety and EMC Reports: For devices with electrical components, compliance with safety and electromagnetic compatibility standards.
  4. Quality Management System (QMS) Documentation:
    • ISO 13485 Certification: Proof of compliance with international standards for quality management systems.
    • Manufacturing Site Master File: Details of the manufacturing facility, including quality management practices.
  5. Regulatory Certificates:
    • Free Sale Certificate (FSC): For imported devices, a certificate stating the device is sold and is safe for use.
    • CE Certificate/US FDA Clearance: Certification for devices cleared in the EU or by the US FDA.
  6. Clinical Evaluation Report (CER):
    • A report summarizing the clinical evidence supporting the device’s performance and safety.
  7. Biocompatibility and Sterilization Reports:
    • Biocompatibility Data: Evidence showing the materials used are safe for human use.
    • Sterilization Validation: For sterile devices, validation of sterilization processes.
  8. Declaration of Conformity:
    • A declaration by the manufacturer or IAA stating compliance with the Medical Device Rules 2017.
  9. Indian Authorized Agent (IAA) Documentation:
    • Power of Attorney: Authorizing the IAA to act on behalf of the foreign manufacturer.
    • IAA Details: Information on the IAA, including company registration and contact details.
  10. Inspection Report:
    • Provided by MDOs after evaluating the manufacturing site for compliance.
  11. Fees Receipt:
    • Proof of payment for the application processing fees.
  12. Additional Documentation:
    • Any other documentation requested by CDSCO during the review process.
  13. Submission Process:
    • Submit all documents through the CDSCO online portal, with physical copies if required.
  14. Timeline for Documentation Review:
    • The CLA aims to complete the review and approval process within 60 days of application submission.

How “Vaayath” Can Help You?

Navigating the regulatory landscape for Class C and D medical devices in India requires expert knowledge and precision. Vaayath specializes in providing comprehensive support for medical device approval with the CDSCO. We guide you through every step of the licensing process—from classification and documentation preparation to application submission and compliance with quality management standards.

Our experienced team ensures that your device meets all regulatory requirements efficiently, minimizing delays and costs. With our support, you can confidently achieve timely approval for your Class C and D medical devices, ensuring a smooth entry into the Indian market.

Trust us to handle the complexities of regulatory compliance, allowing you to focus on innovation and growth in the healthcare sector.

FAQs

Q1: What is CDSCO?

CDSCO is the regulatory authority in India responsible for the regulation and approval of medical devices, drugs, and cosmetics.

Q2: What are Class C & D medical devices?

Class C devices are moderate to high-risk, while Class D devices are high-risk, requiring stringent regulatory oversight.