Manufacturing License Applications
We handle complete application dossiers for Indian manufacturers:
Class A & B Devices
- MD-3 Application for Manufacturing License
- MD-5 Manufacturing License for sale or distribution
- Full technical documentation assembly
- Quality Management System evidence preparation
Class C & D Devices
- MD-7 Application for Manufacturing License
- MD-9 Manufacturing License for sale or distribution
- Comprehensive Risk Management documentation
- Clinical evidence assembly
Loan License Applications
For companies using licensed manufacturing facilities:
Class A & B Devices
- MD-4 Application for Loan License
- MD-6 Loan License to manufacture for sale or distribution
Class C & D Devices
- MD-8 Application for Loan License
- MD-10 Loan License to manufacture for sale or distribution
Import License Services
Commercial Import (MD-14, MD-15)
- Acting as Authorized Indian Agent
- Complete Import License application management (MD-14, MD-15)
- Technical documentation assembly per Fourth Schedule
- Liaison with CDSCO authorities
Special Import Permissions & Test License
- MD-16: Import for clinical investigations, testing, evaluation.
- MD-17: Application for permission to import small quantities for testing.
- MD-18: Import for patient treatment by hospitals.
- MD-20: Import for personal use.
Novel Device Approvals
Medical Devices without Predicate
- MD-26 Application for permission to import/manufacture
- MD-27 Permission for devices without predicate
New In Vitro Diagnostic Devices
- MD-28 Application for permission to import/manufacture
- MD-29 Permission for new IVD devices
Post-Market Surveillance
- Post-Market Surveillance Plan development.
- Periodic Safety Update Report (PSUR) preparation.
- Vigilance reporting systems.
- Market surveillance and competitor monitoring.