Domestic manufacturers
New and existing manufacturers seeking CDSCO manufacturing licenses for Class A-D medical devices.
- MD-3
- MD-5
- MD-7
- MD-9
CDSCO · Medical Devices
CDSCO Medical Device Licensing Consultant in India
Identify the right CDSCO license route for your device class, intended use, and business model. NQSC supports documentation, Sugam portal coordination, and authority liaisoning.
- 25+Years Experience
- 500+Companies
- CDSCO Support
- Licensing · Sugam
Medical device licensing pathway
- 1Confirm device class and intended use
- 2Select manufacturing, loan, import, or test route
- 3Prepare technical and site documentation
- 4Plan Sugam portal submission
MD-3/5MD-7/9MD-14/15Class A-DSugam
Which licensing route applies?
- Class A/B manufacturingMD-3/5 · Loan MD-4/6
- Class C/D manufacturingMD-7/9 · Loan MD-8/10
- ImportMD-14/15
- Testing / samplesMD-12/13 · MD-16/17
Who needs this
Who needs CDSCO licensing support
NQSC supports manufacturers, importers, IVD companies, and startups in identifying the correct CDSCO route, forms, and documentation scope.
Importers and Indian agents
Importers, distributors, and authorised agents preparing import license applications for foreign manufacturers.
- MD-14
- MD-15
- PoA
IVD and diagnostic companies
IVD teams preparing classification, performance files, and India pathway documentation.
- IVD
- CDSCO
- Performance
Medical device startups
Early-stage teams planning their first CDSCO submission with limited internal regulatory capacity.
- Class A/B
- Startup
Foreign OEMs entering India
Overseas manufacturers aligning device documentation, Indian agent requirements, and import route.
- PoA
- Import
- MD-15
Existing license holders
Companies managing product additions, amendments, retention fees, and post-approval changes.
- Amendment
- Retention
- Updates
Documentation
Documentation typically reviewed for CDSCO licensing
Grouped for a quick readiness review before CDSCO Sugam filing.
Application
- Cover letter and license type confirmation
- Authorized signatory and company registration
- Power of Attorney, if applicable
- Fee payment and portal submission proof
Technical File
- Device description and intended use
- Classification rationale and risk summary
- Labels, IFU, and packaging artwork
- Standards list, ISO/IEC as applicable
QMS & Site
- Site master file or layout overview
- ISO 13485 or QMS summary, where applicable
- Manufacturing flow and quality records
- Host-site license evidence for loan license
Testing & Evidence
- Test reports and validation summaries
- Sterilization or biocompatibility references
- Clinical or performance data, if required
- Batch or sample quantity justification
Authorizations
- Import-export code for import routes
- Power of Attorney for foreign manufacturers
- State FDA or local approvals where required
- Notified body or third-party certificates
Filing Readiness
- Route and MD form confirmation
- Device class and intended-use check
- Gap list before Sugam submission
- Query response preparation
Note: Final document scope is confirmed after reviewing device class, intended use, site status, import status, and filing route.
Process
From route assessment to CDSCO coordination
A clear process for route selection, documentation preparation, Sugam filing support, and query response.
Route assessment
Review device class, intended use, site readiness, and the correct regulatory pathway.
Documentation mapping
Map required MD forms, technical files, QMS records, and supporting evidence.
Application preparation
Prepare application forms, annexures, declarations, and filing-ready documentation.
Sugam portal coordination
Support portal filing steps, fee coordination, uploads, and submission readiness.
Query response
Address CDSCO clarifications, CAPA items, and supplementary documentation requests.
Post-approval support
Track license conditions, renewals, product additions, and post-approval change reporting.
How NQSC helps
Support across licensing, documentation, and coordination
NQSC supports route selection, documentation, Sugam portal coordination, query response, and post-approval compliance.
License route guidance
Practical regulatory advice aligned to device class, intended use, and market stage.
Documentation support
Dossier preparation, checklists, technical files, QMS records, and supporting annexures.
Portal coordination
Support for authority portals, document uploads, query responses, and submission readiness.
Audit readiness
Gap reviews before inspections, notified-body audits, or CDSCO authority assessments.
Post-submission support
Support for clarifications, supplementary documents, CAPA items, and authority follow-up.
Post-approval compliance
Guidance for renewals, product additions, retention fees, and change-control reporting.
Avoid delays
Avoidable issues that delay CDSCO licensing
Issues NQSC often sees during manufacturing, import, test, and loan license readiness reviews.
Site Master File gaps
SMF details not matching actual manufacturing layout, equipment, utilities, or process flow.
Missing ISO 13485 linkage
QMS scope not covering the licensed device family, site activity, or applicable process controls.
Wrong class or route selected
MD-3/5 filed when MD-7/9, loan license, import license, or test license route is required.
Unvalidated processes
Validation records missing for sterilization, cleanroom, software, packaging, or special processes.
Incomplete technical file
Device description, intended use, risk summary, labels, IFU, or standards evidence not aligned.
Missing authorization or PoA
Import or foreign manufacturer applications delayed due to incomplete authorization, agent, or PoA documents.
Client trust
Client feedback on NQSC support
Feedback from teams supported across certification, regulatory documentation, and compliance coordination.
ISO · CE · CDSCO
“Excellent support throughout certification activities, including ISO, CE marking and CDSCO submissions.”
CDSCO · Manufacturing
“Fast and accurate service.”
Regulatory Support
“We are fully satisfied with the services provided by NQSC.”
Selected clients supported by NQSC
FAQ
Questions before you apply
Short answers on forms, timelines, restrictions, and how NQSC supports your pathway.
MD-3 is the application form for Class A/B manufacturing license. MD-5 is the license granted after review. For Class C/D devices, the usual route is MD-7 for application and MD-9 for license grant. NQSC helps confirm the correct route and prepare the required documentation.
ISO 13485 or equivalent QMS evidence is commonly required as part of manufacturing license readiness. The exact requirement depends on device class, site activity, manufacturing process, and route.
Timelines depend on device class, documentation readiness, site status, audit requirements, and authority queries. NQSC helps reduce avoidable delays by preparing documentation and supporting query responses.
Yes. NQSC supports route review, host-site documentation, loan license filing support, and planning the transition toward own manufacturing license where applicable.
For medical device import licensing, MD-14 is generally the application and MD-15 is the import license grant. Foreign manufacturers usually need an authorised Indian agent and Power of Attorney.
NQSC supports route selection, documentation preparation, Sugam portal coordination, and query response. Filing responsibility and authorization are confirmed based on the client's role, company details, and applicable route.
Unsure which CDSCO license fits your device?
Share your product class, site, and market plan. NQSC will outline the right pathway and documentation scope.