Manufacturers planning validation testing
Domestic test licenses for evaluation, validation, demonstration, or training batches before full manufacturing approval.
- MD-12
- MD-13
CDSCO · Medical Devices
Test License & Loan License Consultant for Medical Devices in India
Plan test batches, samples, and short-term manufacturing with the right CDSCO pathway before filing. NQSC helps prepare documentation, coordinate portal submission, and respond to authority queries.
- 25+Years Experience
- 500+Companies
- CDSCO Support
- MD-12/13 · Loan
Test & loan license pathways
- 1Confirm device class and intended use
- 2Select test vs loan license route
- 3Prepare site and product documentation
- 4File on CDSCO Sugam portal
MD-12/13MD-16/17MD-4/6MD-8/10Test protocol
Which CDSCO 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
When this pathway is relevant
Share your device type, quantity, intended use, and site status. NQSC helps identify the right license type and documentation scope.
Importers bringing samples for evaluation
Test import licenses for devices entering India for evaluation, demonstration, testing, or R&D use.
- MD-16
- MD-17
Loan license for Class A/B devices
Short-term manufacturing at an approved site while the applicant's own facility license is in progress.
- MD-4
- MD-6
Loan license for Class C/D devices
Higher-risk devices requiring stricter documentation and central authority alignment before sale.
- MD-8
- MD-10
Foreign OEMs working with Indian test partners
Documentation alignment between overseas product specifications and Indian test-license expectations.
- India pathway
- PoA
IVD and diagnostic companies
Sample import and test licensing support for reagents, kits, instruments, and diagnostic products.
- IVD
- Performance evaluation
Compare routes
Test license vs loan license
Understand which route fits your current stage before preparing forms and documentation.
Test License
Best for: evaluation, validation, demonstration, training, or sample batches.
- Used before full manufacturing or import approval
- Linked to intended use, quantity, and test protocol
- Requires clear documentation before filing
Relevant forms
- MD-12
- MD-13
- MD-16
- MD-17
Loan License
Best for: short-term manufacturing at an approved site.
- Used when your own manufacturing license is pending
- Requires host-site license and documentation alignment
- Applicable route depends on device class
Relevant forms
- MD-4
- MD-6
- MD-8
- MD-10
Documentation
Documentation typically reviewed before filing
Grouped for a quick readiness review before CDSCO Sugam filing.
Application
- Cover letter with license type and device class
- MD form selection based on routeMD-12 / MD-13MD-16 / MD-17MD-4 / MD-6MD-8 / MD-10
- Authorized signatory and company registration proof
- Power of Attorney (if filed through agent)
Technical File
- Device description, intended use, and classification rationale
- Labels and IFU for test / loan batches
- List of standards applied (ISO, IEC, as applicable)
- Risk analysis summary for the device family
QMS & Site
- Manufacturing / testing site details and layout
- ISO 13485 certificate or QMS summary (where applicable)
- Loan license: host site manufacturing license copy
Testing
- Test protocol and validation plan
- Batch records for test quantities
- Sterilization / biocompatibility references (if relevant)
Authorizations
- Import-export code (for test import routes)
- Notified body or third-party reports (Class C/D loan)
- State FDA / local approvals where required
Review & Filing Readiness
- Route confirmation before filing
- Quantity and intended-use justification
- Gap list for missing documents
Note: Final requirements are confirmed after reviewing the device class, intended use, quantity, manufacturing site, and filing route.
Process
From route assessment to CDSCO coordination
A clear process for route selection, document preparation, filing support, and query response.
Route assessment
Confirm device class, quantity, intended use, and whether test or loan license fits your stage.
Documentation mapping
Map the required forms, technical file, test protocol, and supporting documents.
Application preparation
Prepare application forms, annexures, and filing-ready documentation.
Portal coordination
Support CDSCO Sugam filing steps, fee coordination, and document alignment before submission.
Query response
Support clarifications, supplementary data requests, and documentation updates.
Transition planning
Track validity, quantity limits, and path to full manufacturing or import license.
How NQSC helps
Support from route selection to authority coordination
NQSC supports documentation, portal coordination, and follow-up at every stage.
Route selection
Identify the right test or loan license route and related MD forms before submission.
Technical documentation
Prepare application dossiers, test protocols, technical summaries, and supporting annexures.
Portal coordination
Support CDSCO Sugam filing steps, annexures, fee coordination, and submission readiness.
Query response
Prepare structured responses to CDSCO queries, clarifications, and supplementary data requests.
Post-approval tracking
Track license conditions, validity, quantity limits, and transition planning.
Final support scope is confirmed after reviewing device class, intended use, quantity, site status, and filing route.
Avoid delays
Avoidable issues that delay CDSCO filing
Issues NQSC often sees during test and loan license readiness reviews.
Incorrect MD route or form
Selecting a manufacturing route when a test or loan route applies can trigger review delays.
Incomplete test or validation protocol
Missing validation scope, batch size, intended use, or disposal plan can trigger authority queries.
Missing host-site license evidence
Loan license routes require valid manufacturing license evidence from the host site.
Quantity or intended-use mismatch
Exceeding approved test quantities or using test batches commercially can create compliance risk.
Weak ISO 13485 / QMS alignment
Higher-class loan routes may require stronger QMS evidence beyond basic site records.
Unreported design or specification changes
Device changes after license grant may require amendment, review, or fresh filing.
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.
A test license is used for evaluation, validation, demonstration, training, or sample batches. A loan license is used for manufacturing at another approved site when your own manufacturing license is not yet available. NQSC helps identify the route based on device class, intended use, quantity, and site status.
For domestic testing or evaluation, the application and license are generally handled through MD-12 and MD-13. For imported samples, MD-16 and MD-17 are commonly used. The final route depends on device type, intended use, quantity, and filing purpose.
No. A test license is generally meant for evaluation, validation, demonstration, training, testing, or sample use. It should not be treated as a commercial sale route.
Timelines can vary based on device class, documentation quality, portal queries, and authority review. NQSC helps prepare documents and respond to queries to reduce avoidable delays.
NQSC supports route selection, document preparation, portal coordination, and query response. Filing responsibility and authorization are confirmed based on the client's role, company details, and applicable route.
Teams usually plan the transition when regular manufacturing, larger quantities, own-site production, or long-term market supply is required. NQSC helps review the current license status and next documentation requirements.
Need clarity on the right license pathway?
Share your device class, quantity, intended use, and site status. NQSC will help identify whether test, loan, import, or manufacturing license applies.
Practical guidance on route selection, documentation scope, and next steps.