Domestic manufacturers
Sites preparing MD-3/5 or MD-7/9 manufacturing licenses, SMF records, and QMS evidence for Class A to D devices.
- MD-3/5
- SMF
- Manufacturing
Industry · Medical Devices
Medical device compliance in India and export markets
Manufacturers, importers, IVD companies, and exporters use NQSC for CDSCO licensing under the Medical Devices Rules 2017, ISO 13485 QMS, CE marking, FDA 510(k), and technical documentation.
- 25+Years Experience
- 500+Companies
- Class A-D
- CDSCO · MDR
Medical Devices
CDSCO · ISO 13485 · CE
CDSCO licensing, QMS certification, technical files, and export documentation for Class A to D devices in India and overseas markets.
Who we help
Medical device teams we support
Manufacturers, importers, IVD companies, and exporters at different licensing and certification stages.
Importers and Indian agents
Teams filing MD-14/15 import licenses with PoA, foreign manufacturer documentation, and device master records.
- MD-14/15
- PoA
- Import
IVD and diagnostic companies
IVD classification, performance evaluation, and technical files aligned with India pathways and EU IVDR where export applies.
- IVD
- Performance
- IVDR
Exporters to EU or USA
Organisations building CE technical documentation, GSPR evidence, or FDA 510(k) files alongside India licensing.
- CE
- 510(k)
- GSPR
Test and loan license applicants
Companies planning test batches, samples, or short-term manufacturing before full commercial licensing.
- MD-12/13
- Loan
- Test
Post-approval maintenance
Licensed sites managing renewals, change control, internal audits, and CAPA before surveillance audits.
- CAPA
- Audit
- Renewal
Typical clients
Common medical device profiles
Audience types often seen on NQSC device projects. Each may need a different service page entry point.
Medical Device Manufacturers
CDSCO licensing, ISO 13485, technical documentation, and audit readiness for Class A to D devices.
CDSCO · ISO 13485 · Technical File
Importers & Indian Agents
Import licensing, authorised agent documentation, Power of Attorney, and CDSCO coordination.
MD-14/15 · PoA · CDSCO
IVD & Diagnostic Companies
IVD classification, performance evaluation files, technical documentation, and India pathway support.
IVD · Performance File · MDR 2017
Exporters Targeting EU / USA
CE, EU MDR, US FDA, clinical evaluation, risk files, and market-access documentation.
CE · EU MDR · US FDA
Regulatory context
India and export frameworks for devices
Medical devices in India are regulated under the Medical Devices Rules 2017 with risk-based classification. Export markets add EU MDR/IVDR or US FDA requirements.
CDSCO regulates manufacture, import, sale, and clinical investigation of medical devices and IVDs through published MD forms and the Sugam portal.
Source: CDSCO
Risk class (A to D) determines licensing route, technical documentation depth, and post-market obligations.
Source: Medical Devices Rules 2017
EU MDR 2017/745 and IVDR 2017/746 set conformity requirements for CE marking in European markets.
Source: EU MDR
US FDA 510(k) premarket notification applies to many device types sold in the United States when a predicate device strategy is viable.
Source: US FDA
NQSC services
Services for medical devices
Open the service page that matches your license, QMS, export, or audit need.
Typical pathway
How teams usually progress
From route confirmation through documentation, filing, and post-approval maintenance.
Route and class confirmation
Confirm device class, intended use, and whether you need manufacturing, import, test, or export documentation first.
Documentation gap review
Compare site records, QMS, and technical files against CDSCO or export market checklists.
Structured preparation
Prepare MD forms, SMF, risk files, and evidence packs aligned to the chosen license or certification route.
Filing and authority liaison
Support Sugam submissions, query responses, and coordination with CDSCO or notified bodies as applicable.
Audit and post-approval support
Maintain readiness for inspections, renewals, and design or supplier changes after approval.
Avoid delays
Common mistakes in this sector
Issues NQSC often sees during readiness reviews before filing or audit.
Wrong license route for device class
Filing under a pathway that does not match class, intended use, or site activity leads to rework and timeline loss.
Incomplete SMF or technical file
Missing design, risk, or clinical evidence is a common cause of CDSCO or notified body queries.
QMS not aligned to audits
ISO 13485 documentation that does not match actual processes fails certification or surveillance audits.
Export files disconnected from India license
CE or 510(k) documentation that contradicts India master records creates authority questions in both markets.
Late PoA or foreign manufacturer records
Import licenses stall when authorised agent or overseas manufacturer paperwork is not ready before filing.
FAQ
Medical device industry questions
Licensing roles, service page entry points, and parallel India and export work.
No. NQSC prepares documentation and supports readiness. CDSCO issues licenses. Accredited bodies issue ISO 13485 certificates.
Start with the CDSCO Medical Device Licensing hub page for route selection, then open manufacturing, test, or import pages as needed.
Yes, where classification and technical documentation requirements differ. Share your product type during consultation.
Yes. Many exporters run parallel India licensing and EU technical file work. Related service pages are linked from this industry view.
Device description, class if known, site status, target markets, and a list of existing SOPs, drawings, or prior submissions.
Discuss your medical device pathway
Tell us your device class, India and export goals, and current documentation. NQSC will outline the right service pages and next steps.
CDSCO licensing, ISO 13485, CE, 510(k), and technical file support.