Comprehensive CDSCO Regulatory Services

Establishing precise device intelligence, strategic grouping, and compliant registration frameworks before formal dossier submission.

Regulatory Strategy

Medical Device Classification

Medical Device Registration

Customized regulatory roadmaps identifying optimal device pathways, data requirements, and timeline optimizations for fast market launch in India.

Accurate risk-based classification under Medical Devices Rules 2017 across Class A, B, C, and D parameters.

End-to-end management of regulatory dossiers, portal submissions, and official license approvals for foreign and Indian manufacturers.

Medical Device Grouping

Predicate Analysis

New Medical Device Permission

Strategic device grouping into single, family, system, or kit categories to optimize filing fees and streamline maintenance.

Establishing substantiating clinical and technical equivalence with approved predicates to support expedited approval routes.

Authoring comprehensive specialized dossiers for novel medical technologies lacking predicate approvals in the Indian ecosystem.

Manufacturing, Import & Wholesale Licensing

Securing mandatory commercial and operational licenses for domestic manufacturing, global import, testing, and national distribution.

Test License

Import License

Manufacturing License

Procurement of Form MD-13 test licenses required for importing small batches for testing, evaluation, and clinical investigations.

Filing and tracking of Form MD-15 import licenses for overseas device manufacturers through authorized Indian agents.

Full audit preparation and submission for Form MD-5 and MD-9 domestic manufacturing licenses across State and Central authorities.

Loan License

Wholesale Licence for sale & distribution

Indian Authorised Representative

Structuring and executing Form MD-6 and MD-10 loan license applications for virtual or asset-light medical device companies.

Managing post-grant product additions, variant inclusions, and manufacturing site endorsements on active licenses.

Streamlined filing for Form MD-42 wholesale registration allowing legal commercial sale and nationwide distribution.

Endorsement License

Structuring and executing Form MD-6 and MD-10 loan license applications for virtual or asset-light medical device companies.

Clinical Trials, SEC Representation & Queries

Direct advocacy, technical defense, and clinical protocol approvals before CDSCO committees and expert panels.

Clinical Trial Permission

Subject Expert Committee (SEC)

Technical Presentation to CDSCO

Protocol compilation, investigator brochure review, and submission for Investigational Device Exemptions and clinical trials.

Strategy development and direct technical advocacy during mandatory CDSCO Subject Expert Committee meetings.

Preparing clear scientific slideshows and defending device safety data directly in technical committee presentations.

Query Submission & Handling

Labelling Compliance

Rapid scientific evaluation and compilation of robust responses to technical deficiency letters issued by CDSCO reviewers.

Comprehensive verification of device labels, outer cartons, IFUs, and symbols against MDR 2017 and Legal Metrology provisions.

Ensuring continuous license validity, change approvals, export certifications, and regulatory tender documentation.

License Retention & Renewal

Post Approval Changes

Free Sales Certificate

Timely processing of 5-year retention fee submissions and renewal filings to guarantee non-stop commercial authorization.

Filing major and minor change notifications regarding shelf life, design modifications, component suppliers, or site changes.

Procuring official FSC credentials from CDSCO for Indian medical device manufacturers registering in international export markets.

Market Standing Certificate

Non Conviction Certificate

Compiling commercial track record proof and securing government Market Standing Certificates required for major public tenders.

Obtaining certified state licensing authority documentation verifying complete absence of regulatory non-compliance or penalties.