Class A/B manufacturers
Low–moderate risk devices requiring MD-3 and MD-5 manufacturing licenses.
MD-3 · MD-5
CDSCO · Manufacturing
CDSCO Manufacturing License Consultant in India
Prepare CDSCO manufacturing license applications for Class A-D medical devices with structured site, QMS, technical file, and Sugam filing support.
- 25+Years Experience
- 500+Companies
- CDSCO Support
- MD-3/5 · MD-7/9
Manufacturing license pathway
- 1Confirm device class and manufacturing route
- 2Prepare SMF, DMF, and QMS evidence
- 3Align ISO 13485 and site records
- 4File MD-3/5 or MD-7/9 on Sugam
MD-3MD-5MD-7MD-9SMFDMF
Which manufacturing route applies?
- Class A/B own manufacturingMD-3 application · MD-5 license
- Class C/D own manufacturingMD-7 application · MD-9 license
- Loan manufacturing A/BMD-4 application · MD-6 license
- Loan manufacturing C/DMD-8 application · MD-10 license
Who needs this
Teams we support on this pathway
Share your situation. NQSC helps identify the right license type and documentation scope.
Class C/D manufacturers
Higher-risk devices with stricter technical and QMS expectations.
MD-7 · MD-9
Contract manufacturers
Sites manufacturing for OEMs needing license alignment and documentation.
SMF · QMS
Facilities upgrading scope
Existing licensees adding new device families or manufacturing lines.
Amendment · Variation
Documentation
Documentation typically reviewed for manufacturing license
Grouped for readiness review before MD-3/5 or MD-7/9 Sugam filing.
Application
- Cover letter and manufacturing license route confirmation
- Company constitution and authorized signatory details
- MD-3 or MD-7 application readiness
- Fee payment and Sugam submission proof
Site Master File
- Manufacturing site layout and area details
- Equipment, utilities, and process flow
- Qualified technical staff details
- Manufacturing and quality control arrangements
Device Master File
- Device description and intended use
- Materials, specifications, and design details
- Labels, IFU, and packaging artwork
- Standards list and risk summary
QMS & ISO 13485
- ISO 13485 certificate or QMS summary
- SOPs, quality records, and CAPA process
- Internal audit and management review records
- Device-family scope alignment
Testing & Validation Evidence
- Test reports and validation summaries
- Sterilization or biocompatibility references
- Process validation records where applicable
- Clinical or performance evidence if required
Audit & Filing Readiness
- Route confirmation for MD-3/5 or MD-7/9
- Gap list before Sugam filing
- Notified body or CDSCO inspection readiness
- Query response preparation
Note: Final document scope is confirmed after reviewing device class, manufacturing site, QMS status, product risk, and selected MD form.
Process
From site readiness to manufacturing license filing
A structured process for route confirmation, SMF/DMF preparation, QMS alignment, Sugam filing, and query response.
Route confirmation
Confirm whether MD-3/5 or MD-7/9 applies based on device class, manufacturing site, and intended product scope.
Site and QMS review
Review site readiness, ISO 13485/QMS records, manufacturing flow, and quality control arrangements.
SMF and DMF preparation
Structure Site Master File, Device Master File, technical details, labels, IFU, and supporting evidence.
Sugam filing support
Support application forms, annexures, fee coordination, uploads, and submission readiness.
Audit and query response
Support notified body or CDSCO audit readiness, clarifications, CAPA items, and supplementary documents.
Post-approval planning
Track license conditions, retention, product additions, renewals, and post-approval change reporting.
How NQSC helps
Support across SMF, DMF, QMS, and Sugam filing
NQSC supports manufacturing route confirmation, documentation preparation, QMS alignment, Sugam filing, query response, and post-approval compliance.
Manufacturing route guidance
Identify whether MD-3/5 or MD-7/9 applies based on device class, site readiness, and product scope.
SMF and DMF preparation
Structure Site Master File, Device Master File, technical summaries, labels, IFU, and supporting evidence.
QMS and ISO 13485 alignment
Review ISO 13485 scope, SOPs, quality records, CAPA, internal audits, and management review evidence.
Sugam portal coordination
Support application forms, annexures, fee coordination, uploads, and submission readiness.
Audit and query readiness
Support notified body or CDSCO audit preparation, clarifications, CAPA items, and supplementary documents.
Post-approval compliance
Guidance for retention fees, product additions, renewals, and change-control reporting.
Avoid delays
Avoidable issues that delay manufacturing license filing
Issues NQSC often sees during MD-3/5 and MD-7/9 manufacturing 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 selected when MD-7/9, loan license, or another route is required.
Unvalidated processes
Validation records missing for sterilization, cleanroom, packaging, software, or special processes.
Incomplete Device Master File
Device description, intended use, specifications, labels, IFU, risk summary, or standards evidence not aligned.
Weak audit readiness
Site records, QMS evidence, technical files, or CAPA records not ready for notified body or CDSCO review.
Client trust
Client feedback on NQSC manufacturing support
Feedback from teams supported across CDSCO licensing, ISO 13485, manufacturing 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, documentation, and how NQSC supports your manufacturing license 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.
MD-7 is the application form for Class C/D manufacturing license. MD-9 is the license granted after review. These routes usually require stronger technical documentation, QMS evidence, and audit readiness.
ISO 13485 or equivalent QMS evidence is commonly required for manufacturing license readiness. The final requirement depends on device class, manufacturing activity, product risk, and applicable route.
Common documents include application forms, SMF, DMF, ISO 13485 or QMS records, manufacturing flow, labels, IFU, test reports, validation evidence, and authorization documents where applicable.
Timelines depend on device class, site readiness, documentation quality, audit requirements, and authority queries. NQSC helps reduce avoidable delays by preparing documentation and supporting query responses.
Yes. NQSC can support product additions, retention planning, renewals, change-control documentation, and query responses after license grant.
Planning a CDSCO manufacturing license?
Share your device class, manufacturing site status, and QMS readiness. NQSC will help identify the right MD-3/5 or MD-7/9 pathway and documentation scope.