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Medical Devices Registration in India

  • Medical Devices Market in India is at $11 billion, poised to grow to $50 billion over the next five years

  • India’s current share in the global market is at 1.5%, poised to grow to 12% over the next 25 years

  • India imports 75% of its medical devices currently 

  • Key products marketed in India include Medical and Surgical Instruments; Medical Imaging Equipment; Electro-Medical Equipment; Orthopedic and Prosthetic Appliances; Cancer Diagnostic Solutions; Ophthalmic Instruments and Appliances; Orthodontic Equipment and Dental Implants; Point of Care Testing (POCT) Diagnostic Devices; Digital Healthcare, Health IT, and Telemedicine Services. 

Regulatory Authorities in India for Medical Devices

In India, medical device registration 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). 

Medical Devices in India are governed by 

Classification of Medical Devices in India

Medical equipment are categorised 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. 

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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 

Medical Devices Registration Services in India

  • Authorized Representative and Import Services

  • Gap Analysis

  • Regulatory Intelligence and Strategy

  • Consultation and Meeting

  • Technical File Preparation and Submission

  • Quality Management System Implementation

  • Audit Support

  • Quality Training

  • Response to Queries

  • Clinical Evaluation and Post Marketing Evaluation

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