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