Key Responsibilities

CDSCO Regulatory Activities
Prepare and review regulatory submissions for medical devices and IVDs under CDSCO requirements.
Assist in obtaining manufacturing licenses, import licenses, and other regulatory approvals under the Medical Devices Rules, 2017.
Coordinate with clients for collection of required regulatory and technical documentation.
Monitor updates, notifications, guidance documents, and amendments issued by CDSCO.

Regulatory Documentation
Prepare and review Device Master Files (DMF) and Plant Master Files (PMF).
Review product labeling, Instructions for Use (IFU), packaging artwork, and associated documentation for regulatory compliance.
Support the preparation of declarations, undertaking letters, authorization letters, and regulatory dossiers.
Maintain regulatory records, submission trackers, and licensing databases.

Medical Device Classification & Compliance
Assist in the classification of medical devices and IVDs as per CDSCO classification rules.
Conduct regulatory gap assessments against applicable CDSCO requirements.




Support compliance activities related to licensing, registration, and post-approval changes.
Ensure documentation complies with applicable Indian regulatory requirements.

Client Coordination
Communicate with clients regarding documentation requirements, project timelines, and regulatory updates.
Support project execution and ensure timely completion of assigned activities.
Prepare status reports and regulatory updates for internal and client review.

Required Knowledge
Valuable understanding of Medical Devices Rules (MDR), 2017.
Knowledge of the CDSCO regulatory framework for medical devices and IVDs.
Understanding of device classification (Class A, B, C, and D).
Familiarity with manufacturing and import licensing processes.
Understanding of Device Master File (DMF) and Plant Master File (PMF) requirements.
Working knowledge of the CDSCO SUGAM Portal.
Basic understandin

📌 Cdsco Regulatory Affairs Executive Makarba (India)
🏢 Maven Profcon Services
📍 India