CDSCO Licensing Checklist
Initial document and pathway checklist for medical device manufacturing, import, test and loan licence planning.
RESOURCES
Resources for regulatory and certification readiness
Practical checklists, FAQs, document guidance, and pathway notes for medical device, pharma, food, laboratory, cleanroom and management system compliance.
Compliance resources being prepared
NQSC is preparing practical guidance material for common licensing, certification, validation and audit-readiness needs.
ISO 13485 Readiness Checklist
QMS readiness points for medical device manufacturers preparing for certification or audit.
Cleanroom Validation Checklist
Key readiness points for cleanroom design, qualification, monitoring and validation planning.
CE / EU MDR Documentation Guide
Guidance areas for technical files, GSPR, clinical evaluation, risk management and PMS readiness.
Audit Readiness FAQ
Common questions before internal audits, supplier audits, certification audits and regulatory inspections.
Post-Approval Maintenance Guide
Maintenance guidance for renewals, retention, surveillance audits, post-approval changes and compliance updates.
Common questions before starting compliance work
NQSC helps improve approval readiness through pathway clarity, structured documentation, audit preparation, query-response support, and communication discipline. Final regulatory or certification decisions remain with the respective authorities, notified bodies, or certification bodies.
NQSC helps with documentation, forms, technical files, application readiness, coordination, and query-response support as per agreed scope. Official submissions and declarations remain with the applicant, manufacturer, importer, or authorised agent.
Start with a structured requirement review. NQSC reviews your product, intended use, risk class, facility status, target market, and current documents before recommending the suitable pathway.
Yes. NQSC supports post-approval changes, retention planning, surveillance audit readiness, CAPA, management review, training, and ongoing compliance maintenance.
Need a checklist before it is published?
Share your product category, industry and current stage. NQSC can guide you on the documents, validation needs and compliance pathway required before filing or audit preparation.