Drug and medical device licensing support

Assessment and deliverables

We distinguish manufacture, import, sale and distribution and assemble the facts needed to identify the appropriate central or state process. Medical-device classification depends on the intended use and current classification material.

CDSCO’s description of regulatory functions places drug manufacture, sale and distribution primarily with state authorities, while central responsibilities include new-drug approval and oversight of imported-drug quality. Identify the product category and activity before selecting the authority; this overview is not a complete application checklist.

The work can include a regulatory pathway note, dossier index, document gap register and submission coordination. Changes in product claims or intended use are treated as regulatory questions rather than simple marketing edits.

Prepare a product register linking each model or formulation to its intended use, manufacturer, manufacturing site and proposed business role. Keep marketed products separate from products still under development so the application brief reflects the version actually being assessed.

Documents to prepare

• Product composition or technical dossier
• Intended use, labelling and risk classification basis
• Manufacturing-site and quality-system records
• Existing licences and authorised representative arrangements

Index dossier documents by product and revision. Record who supplied each test report, label, quality-system document and authorisation, along with any missing annexures. A document bearing a similar product name should be checked against the actual model and site before being relied upon.

A practical example

A diagnostic product marketed for a new purpose may need a classification and dossier review even when its physical design has not changed.

For example, a supplier may provide a dossier for one diagnostic use while the proposed brochure describes another. Flag that difference for specialist review and hold the disputed wording in the artwork register until the evidence and intended-use statement are reconciled.

Scope and responsibilities

Clinical evidence, technical evaluation, testing and qualified regulatory opinions require specialist involvement. No product may be represented as approved merely because documentation has been submitted.

The engagement letter records the sites or products covered, filing assistance, query support and fees. You approve the factual application details and retain responsibility for ongoing operations.

The handover separates documents assembled, questions awaiting a technical opinion, applications submitted and decisions received. Name the person responsible for answering authority queries and keeping later product, site and labelling changes connected to the approved scope.