Medical Device Registration Process in India with CDSCO

Process for Registration of Medical Devices with CDSCO in India

The process for Registration of Medical Devices with CDSCO in India includes the following steps:

1. Application Submission:

For manufacturers and importers of medical devices, the initial step involves submitting an application to CDSCO. The type of application form depends on the classification of the device:

• Class A/B Devices: Use Form MD-14.

• Class C/D Devices: Use Form MD-15.

These forms are submitted via the online Sugam portal.

2. Review and Scrutiny:

Once the application is submitted, CDSCO reviews the documents for completeness and compliance with regulatory requirements. Key documents include:

• Device Master File (DMF): Detailed technical information about the device.

• Performance Evaluation Report (PER): Clinical data supporting safety and efficacy.

• Quality Management System (QMS) Certification: Ensures adherence to quality standards.

3. Inspection and Verification:

CDSCO may conduct inspections of manufacturing facilities to verify compliance with Good Manufacturing Practices (GMP) and other quality standards. This step ensures that the device meets safety and performance criteria.

4. Approval and Licensing:

Upon successful review and verification, CDSCO grants approval for the medical device. The manufacturer or importer receives a registration certificate. For importers, this certificate also serves as an import license.

Additional Points to Note:

• Voluntary vs. Mandatory Registration:

  • Initially, the registration of Class A, B, C, and D devices was voluntary for 18 months (from 1st April 2020 to 30th September 2021).

  • After the voluntary period, mandatory registration kicks in:

    • Class A & B devices: Mandatory registration for 12 months after the voluntary period.

    • Class C & D devices: Mandatory registration for 24 months after the voluntary period.

  • From 1st October 2022, Class A & B devices fall under the licensing regime, and from 1st October 2023, Class C & D devices follow suit.

Remember, this process is critical for ensuring patient safety and maintaining quality standards. If you have any specific questions or need further details, feel free to ask!