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Regulations for Registration of Medical Device in India (CDSCO)

Updated: Jun 20

Regulatory Authorities in India for Medical Devices

Regulations for Registration of Medical Device in India is overseen by the Central Drugs Standard Control Organisation (CDSCO), which is part of the Ministry of Health & Family Welfare's Directorate General of Health Services. The CDSCO is India's National Regulatory Authority (NRA) that oversees registration of medical device. ​ Medical Devices in India are governed by


Classification as per Regulations for Registration of Medical Device in India (CDSCO)

Medical equipment are categorized into four risk categories: A, B, C, and D. The CDSCO application processing fees are determined by the device categorization. The application process takes 6 to 9 months regardless of device categorization. ​ Once accepted, each manufacturing site receives an Import Licence, MD Form 15, which lists the allowed products.

Process for Registration of Medical Devices in India

I. Medical Devices Classification​ ​ II. Appoint Authorized Representative

  • The technical file in CSDT format is prepared and submitted to MDA by Authorized Representative

III. Gap Analysis

  • Collation of Documents and evaluation and identification of any gaps

IV. Compile Device Master File

  • Compilation of the Device Master File and other site related documents

V. Create SUGAM Account

  • Compilation of the Device Master File and other site related documents

VI. Prepare Technical Documentation and Upload to SUGAM​​ VII. Review and Approval by CDSCO

Documents Required for Registration of Medical Devices in India

  • Form 40

  • TR6 Challan

  • Power of Attorney

  • Schedule D(I)

  • ISO 13485 Certificate

  • Quality Assurance Certificate

  • CE Certificate

  • Declaration of Conformity

  • Free Sale Certificate

  • Post Marketing Study Reports

  • Plant Master File

  • Device Master File



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