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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