Vericert

CDSCO Certification Types for Medical Devices2. Form MD-3 – Application for Manufacturing License for Class A & B Devices3. Form MD-5 – Manufacturing License for Class A & B DevicesApply to State Licensing Authority (SLA).
For domestic manufacturers of low to medium risk medical devices.
4. Form MD-7 – Application for Manufacturing License for Class C & D Devices5. Form MD-9 – Manufacturing License for Class C & D DevicesApply to CDSCO Head Office (Central Licensing Authority).
For domestic manufacturing of high-risk devices (e.g., cardiac stents, catheters).
6. Form MD-4 – Application for Loan License for Class A & B7. Form MD-6 – Loan License for Class A & B DevicesWhen a manufacturer uses another licensed facility to manufacture.
8. Form MD-8 – Application for Loan License for Class C & D9. Form MD-10 – Loan License for Class C & D DevicesSimilar purpose as MD-4/6 but for high-risk categories.
10. Form MD-11 – Application for Import License for Medical Devices11. Form MD-15 – Import License for Medical DevicesFor foreign manufacturers.
Requires appointment of an Authorized Indian Agent.
Requires:
Free Sale Certificate (FSC)
ISO 13485
Device Master File (DMF)
Plant Master File (PMF)
12. Form MD-12 – Application for Import License for IVDs13. Form MD-16 – Import License for IVD DevicesSpecifically for in-vitro diagnostics.
14. Form MD-14 – Application for Testing License15. Form MD-18 – Testing License to Manufacture for Test or EvaluationRequired for clinical evaluation, R&D, or stability studies.
16. Form MD-17 – Application for Test License for Import17. Form MD-19 – Test License for Import of Medical Device for Testing/EvaluationFor imported samples not for commercial sale.
18. Form MD-20 – Application for Registration of Notified Body19. Form MD-21 – Notified Body Registration CertificateFor certification bodies performing audit of Class A & B manufacturers.
20. Form MD-22 / MD-23 – Application for Clinical Investigation of Medical Device21. Form MD-24 / MD-25 – Permission for Clinical InvestigationApplicable for new or investigational medical devices.

NSWS Test License Services We Offer

License Type Form Purpose

Manufacture for Testing Form MD-14 / MD-18 Clinical trials, stability studies, performance evaluation

Import for Testing Form MD-17 / MD-19 Import of unregistered devices for research/demo

 

📦 We Support:

Prototype & innovation testing

 

Clinical trial supplies

 

Bio-compatibility and safety evaluations

 

Third-party performance and usability studies

 

Stability studies and R&D scale production

 

📋 Required Documents:

Justification letter for the device

 

Device details and intended use

 

ISO 13485 certificate

 

Testing protocols and lab details

 

Agreement with CRO/testing facility (if applicable)

 

🌐 Why Choose Us?

✅ Fast NSWS account setup and license filing

 

✅ Support for Indian and foreign entities

 

✅ Liaison with CDSCO and assistance in query response

 

✅ Affordable compliance for startups and innovators