Indian authorised agents
Companies representing foreign manufacturers for CDSCO import license applications.
- PoA
- MD-14
- MD-15
CDSCO · Import License
CDSCO Import License Consultant in India
Prepare CDSCO import license applications for medical devices with structured PoA, device documentation, QMS evidence, technical file, and Sugam filing support.
- 25+Years Experience
- 500+Companies
- CDSCO Support
- MD-14/15 · PoA
Import license pathway
- 1Confirm device class and import route
- 2Prepare PoA and foreign manufacturer records
- 3Align QMS, FSC, labels, and technical evidence
- 4File MD-14 for MD-15 license on Sugam
MD-14MD-15PoAFSCSugam
Which import route applies?
- Class A/B medical devicesMD-14 application · MD-15 license
- Class C/D medical devicesMD-14 application · MD-15 license
- Foreign manufacturerPoA · QMS · FSC
- Indian authorised agentIEC · registration · submission support
Who needs this
Who needs import license support
NQSC supports importers, authorised Indian agents, foreign OEMs, distributors, and IVD companies in preparing MD-14/15 import license documentation.
Foreign medical device OEMs
Overseas manufacturers entering India with device documentation, QMS, and market-access requirements.
- FSC
- QMS
- India access
Medical device importers
Importers preparing device records, labels, IFU, and supporting documents for CDSCO submission.
- Import
- Labels
- IFU
IVD and diagnostic companies
IVD teams preparing classification, performance evidence, and India-specific import documentation.
- IVD
- Performance
- MD-15
Distributors and channel partners
Indian businesses coordinating import license readiness for regulated device portfolios.
- Distributor
- IEC
- CDSCO
Existing import license holders
Companies managing product additions, changes, renewals, retention, and post-approval updates.
- Product addition
- Retention
Compare routes
Import license vs test import license
Understand whether your device requires a commercial import license or a test/sample import route before filing.
Import License
Best for: commercial import and market supply of medical devices in India.
- Filed through MD-14 for license grant in MD-15
- Requires foreign manufacturer documents and Indian authorised agent support
- Linked to device class, product family, and market route
Relevant forms
- MD-14
- MD-15
- PoA
- FSC
Test Import License
Best for: imported samples used for testing, evaluation, demonstration, or R&D.
- Used when devices enter India for non-commercial use
- Usually linked to quantity, intended use, and test protocol
- Should not be treated as a commercial sale route
Relevant forms
- MD-16
- MD-17
- Samples
- Testing
Documentation
Documentation typically reviewed for import license
Grouped for readiness review before MD-14/15 Sugam filing.
Application
- Cover letter and import license route confirmation
- MD-14 application readiness
- Indian authorised agent details
- Fee payment and Sugam submission proof
Power of Attorney
- PoA from foreign manufacturer
- Authorised Indian agent appointment
- Authentication, notarization, or apostille where applicable
- Manufacturer and agent responsibility alignment
Foreign Manufacturer Documents
- Manufacturing site details
- QMS certificate or ISO 13485 evidence
- Free Sale Certificate or market authorization
- Device family and manufacturing site linkage
Technical File
- Device description and intended use
- Classification rationale and risk summary
- Labels, IFU, and packaging artwork
- Standards list and technical evidence
Testing & Performance Evidence
- Test reports and validation summaries
- Sterilization or biocompatibility references
- Clinical or performance evidence, if required
- Batch or product specification records
Filing Readiness
- Route confirmation for MD-14/15
- Gap list before Sugam filing
- Query response preparation
- Post-approval change planning
Note: Final document scope is confirmed after reviewing device class, foreign manufacturer records, Indian authorised agent role, and selected import route.
Process
From import route review to MD-15 license filing
A structured process for import route confirmation, PoA review, documentation preparation, Sugam filing, and query response.
Import route confirmation
Confirm device class, import purpose, authorised agent role, and whether MD-14/15 applies.
PoA and manufacturer review
Review foreign manufacturer documents, Power of Attorney, QMS evidence, and site records.
Technical documentation mapping
Map device description, labels, IFU, standards, FSC, and supporting technical evidence.
Sugam filing support
Support MD-14 application forms, annexures, fee coordination, uploads, and submission readiness.
Query response
Support CDSCO clarifications, supplementary documents, and technical or administrative responses.
Post-license support
Track license conditions, product additions, renewals, retention, and post-approval changes.
How NQSC helps
Support across PoA, documentation, and Sugam filing
NQSC supports import route confirmation, foreign manufacturer documentation, authorised agent coordination, Sugam filing, query response, and post-approval compliance.
Import route guidance
Identify whether MD-14/15 or test import route applies based on device class and intended use.
PoA and agent coordination
Review Power of Attorney, authorised agent details, manufacturer declarations, and responsibility alignment.
Technical file support
Structure device description, labels, IFU, standards, risk summary, and supporting evidence.
QMS and FSC alignment
Review ISO 13485/QMS certificate, Free Sale Certificate, market authorization, and manufacturer records.
Sugam portal coordination
Support application forms, annexures, uploads, fee coordination, and submission readiness.
Post-approval compliance
Guidance for product additions, retention, renewals, amendments, and change-control reporting.
Avoid delays
Avoidable issues that delay import license filing
Issues NQSC often sees during MD-14/15 import license readiness reviews.
Incomplete PoA
Power of Attorney missing required authorization, authentication, manufacturer details, or agent alignment.
QMS certificate mismatch
ISO 13485 or QMS scope not matching the device family, manufacturer site, or product category.
Weak FSC or market evidence
Free Sale Certificate or market authorization not aligned with the device, country, or manufacturer records.
Label and IFU gaps
Labels, IFU, packaging artwork, or product details not matching India import documentation.
Wrong route selected
Commercial import route confused with test/sample import route or incorrect filing purpose.
Incomplete technical file
Device description, intended use, risk summary, specifications, or standards evidence not aligned.
Client trust
Client feedback on NQSC import and regulatory support
Feedback from teams supported across CDSCO import licensing, certification, technical 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, documents, timelines, and how NQSC supports your import license pathway.
MD-14 is the application form for medical device import license. MD-15 is the import license granted after review. NQSC helps prepare the documentation and coordinate the correct filing sequence.
An Indian authorised agent or importer generally applies on behalf of the foreign manufacturer. The role, authorization, and Power of Attorney must be aligned before filing.
Yes, Power of Attorney from the foreign manufacturer is commonly required to authorize the Indian agent. Authentication or notarization requirements may apply depending on the documentation route.
Common documents include PoA, Free Sale Certificate, ISO 13485 or QMS certificate, device description, labels, IFU, technical file evidence, manufacturer details, and Indian agent documents.
Timelines depend on document readiness, device class, foreign manufacturer records, portal queries, and authority review. NQSC helps reduce avoidable delays by preparing documents and supporting query responses.
Yes. NQSC can support product additions, renewals, amendments, retention planning, and post-approval change documentation after license grant.
Planning a CDSCO import license?
Share your device class, foreign manufacturer details, authorised agent status, and document readiness. NQSC will help identify the right MD-14/15 pathway and documentation scope.