Estimated Timeline
30 - 60 Working Days
Applicable Standards
MDR 2017, ISO 13485, Device Master File (DMF), Plant Master File (PMF)
Eligibility Criteria
Medical device manufacturers, Indian Authorized Agents (Form MD-14 / MD-15).
Mandatory Documents Required
Device Master File (DMF) & Plant Master File (PMF)
ISO 13485 Quality Management Certificate
Free Sale Certificate (FSC) from origin country
Clinical Evaluation & Risk Assessment Reports
Indian Authorized Agent Power of Attorney
Step-by-Step Certification Process
1
Device Classification (Class A, B, C, or D)
Handled end-to-end by DTLS India compliance managers, lab liaisons, and government desk officers.
2
SUGAM Portal Filing with Technical Dossier
Handled end-to-end by DTLS India compliance managers, lab liaisons, and government desk officers.
3
Coordination of Notified Body Audit (if Class B/C/D)
Handled end-to-end by DTLS India compliance managers, lab liaisons, and government desk officers.
4
Technical Evaluation by CDSCO Medical Device Officers
Handled end-to-end by DTLS India compliance managers, lab liaisons, and government desk officers.
5
Grant of Import License (MD-15) or Manufacturing License (MD-5/MD-9)
Handled end-to-end by DTLS India compliance managers, lab liaisons, and government desk officers.
Related Compliance Schemes:
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