Vericert

Regulatory Licensing & Compliance

CDSCO Medical Device Manufacturing License (Class A to D)

Drug Manufacturing License (Form 25/28/29)

Site Master File (SMF), Device Master File (DMF)

CE Marking, ISO 13485, WHO-GMP, USFDA assistance

NSWS/CDSCO Portal Registration & Approval

2️⃣ Factory & Facility Setup

Plant layout & architectural drawings (GMP-compliant)

HVAC, cleanroom, water system, ETP/STP design

Civil construction and finishing

Utility setup (compressors, chillers, gensets)

3️⃣ Machinery & Equipment Supply

Sourcing, installation & qualification of:

Blister packing, autoclaves, filling machines, etc.

Sterilizers, labeling, tablet/capsule machines

Nonwoven machinery for masks/gowns/gloves

Medical device assembly & packaging units

4️⃣ Documentation & Quality Systems

SOPs, Quality Manual, Validation Protocols (IQ/OQ/PQ)

Risk Management File (ISO 14971), Technical File

Batch Manufacturing Records (BMR)

Training, CAPA, change control, deviation handling templates

5️⃣ Product Registration & Launch

Product dossier preparation

IVD/medical device import or manufacturing approvals

Trademark, packaging, label design

Third-party testing and stability studies

🚀 Industries We Serve

Medical Devices (Disposables, IVDs, Implants, Catheters)

Pharmaceuticals (Tablets, Capsules, Injectables, Syrups)

Cosmetics & Disinfectants (Licensable under CDSCO)

Ayurveda/Herbal/Nutraceuticals (FSSAI, AYUSH-compliant)

🎯 Why Choose Us?

✅ 100+ Turnkey Projects Delivered Successfully

✅ Regulatory Experts (CDSCO, FDA, WHO)

✅ Transparent Pricing and Timelines

✅ End-to-End Execution with No Subcontract Gaps

✅ Dedicated After-Sales and Regulatory Support

CDSCO Certification Types for Medical Devices
2. Form MD-3 – Application for Manufacturing License for Class A & B Devices
3. Form MD-5 – Manufacturing License for Class A & B Devices Apply 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 Devices

5. Form MD-9 – Manufacturing License for Class C & D Devices

Apply 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 & B

7. Form MD-6 – Loan License for Class A & B Devices

When a manufacturer uses another licensed facility to manufacture.
8. Form MD-8 – Application for Loan License for Class C & D
9. Form MD-10 – Loan License for Class C & D Devices Similar purpose as MD-4/6 but for high-risk categories.1
10. Form MD-11 – Application for Import License for Medical Devices
11. Form MD-15 – Import License for Medical Devices For 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 IVDs

13. Form MD-16 – Import License for IVD Devices

Specifically for in-vitro diagnostics.

14. Form MD-14 – Application for Testing License

15. Form MD-18 – Testing License to Manufacture for Test or Evaluation

Required for clinical evaluation, R&D, or stability studies.
16. Form MD-17 – Application for Test License for Import
17. Form MD-19 – Test License for Import of Medical Device for Testing/Evaluation
For imported samples not for commercial sale.

18. Form MD-20 – Application for Registration of Notified Body
19. Form MD-21 – Notified Body Registration Certificate

For certification bodies performing audit of Class A & B manufacturers.
20. Form MD-22 / MD-23 – Application for Clinical Investigation of Medical Device

21. Form MD-24 / MD-25 – Permission for Clinical Investigation Applicable for new or investigational medical devices.