CDSCO
Compliance Specialist
Global Regulatory Services
What We Offer
CDSCO Licence & Approvals
Comprehensive regulatory support for CDSCO approvals under the Medical Device Rules, including Test Licence (MD12/MD16), Manufacturing/Loan Licences (MD03/MD04/MD07/MD08), Sale & Wholesale Licence (MD41), Import Licence, and permissions for Clinical Trials (MD13/MD14), along with issuance of Free Sale Certificate (FSC), Market Sale Certificate (MSC), and National Conviction Certificate (NCC).
Regulatory Compliance
Global Approvals
- Manufacturing & Import approvals: Test Licence (MD12/MD16), Manufacturing/Loan Licence (MD03/MD04/MD07/MD08), and Import Licence support.
- Sales & clinical permissions: Wholesale Sale Licence (MD41) and Permission to Conduct Clinical Trials (MD13/MD14).
- Other certifications: Facilitation of FSC, MSC, and NCC as required for global trade and compliance.
We deliver end-to-end CDSCO licence support, assessing device classification, preparing MD forms, filing applications, liaising with authorities, securing approvals, and maintaining continuous compliance postmarket monitoring.
Deliverables to the Client
Deliverables
Strategy Memo
Includes timelines, documentation requirements, and risk-based regulatory approach.
Gap Report
Identifies deficiencies with actionable remediation plan and priorities.
Submission-Ready Dossier
Includes Forms, declarations, test reports, labeling, and certificates in prescribed structure.
Portal Filing & Tracking
Continuous tracking of application status and coordination with authorities.
Query Responses
Includes evidence packages, revised documents, and follow-up communications.
Approval Handover
Guidance on scope of approval, conditions, and compliance obligations.
Lifecycle Compliance Register
Tracks changes, reporting timelines, and ongoing regulatory compliance requirements.
Benefits
Faster approvals
Streamlined documentation and submissions that reduce review cycles and accelerate time-to-market.
Fewer regulator queries
High-quality, compliant dossiers that minimize deficiencies and follow-up questions from authorities.
Faster Approvals
Streamlined submissions and proactive regulatory planning.
Lower compliance risk
Proactive gap identification and mitigation to prevent regulatory non-conformities and penalties.
Transparent tracking
Real-time visibility on application status, milestones, and regulatory commitments.
Reduced internal workload
Expert support that minimizes burden on your in-house QA/RA and clinical teams.
Sustained post-approval compliance
Ongoing monitoring and lifecycle management to ensure continuous regulatory adherence.
Benefits for Your Organization
Call To Action
Simplify Compliance. Accelerate Market Access.
Our global team supports medical device and IVD manufacturers with end-to-end regulatory, quality, and clinical services-ensuring safe, effective, and compliant products at every stage.
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