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
Premarket Notification (510(k))
- Predicate device identification and substantial equivalence analysis.
- Full 510(k) USFDA submission preparation.
- Mandatory eSTAR template implementation.
- Performance testing data assembly.
- Labeling, User Manual, and instructions for use review, compliant with standards like ISO 15223.
Premarket Approval (PMA)
- Investigational Device Exemption (IDE) application.
- Clinical trial design and protocol development.
- Complete PMA application assembly.
- Clinical data analysis and presentation.
- Manufacturing facility information preparation.
De Novo Classification Requests
- Novel device classification strategy (FDA De Novo).
- Risk-benefit analysis documentation.
- Clinical and technical evidence assembly.
- Regulatory pathway justification.
Quality System Compliance
- Quality Management System implementation guidance.
- QMSR/ISO 13485 compliance support.
- Pre-audit preparation and gap analysis.
- Corrective and preventive action systems.
Post-Market Compliance
- Establishment registration and device listing.
- Unique Device Identification (UDI) implementation.
- Medical Device Reporting (MDR) compliance.
- Annual reporting and compliance maintenance.
Technical Documentation
- Complete Technical File assembly per EU MDR Annex II & III.
- Device description and specifications.
- Design and manufacturing information.
- General Safety and Performance Requirements (GSPR) checklist.
- Benefit-risk analysis documentation.
Quality Management System
- ISO 13485:2016 implementation support.
- QMS documentation development
- Notified Body audit preparation.
- Process validation documentation.
Clinical Evaluation
- Clinical Evaluation Plan (CEP) development.
- Clinical Evaluation Report (CER) writing.
- Literature search and review.
- Clinical data analysis and synthesis.
- Post-Market Clinical Follow-up (PMCF) planning.
Risk Management
- Complete Risk Management file per ISO 14971.
- Risk Analysis, evaluation, and control documentation.
- Risk management plan and report.
- Residual risk assessment and benefit-risk determination.
Post-Market Surveillance
- Post-Market Surveillance Plan development.
- Periodic Safety Update Report (PSUR) preparation.
- Vigilance reporting systems.
- Market surveillance and competitor monitoring.
Risk Management File (ISO 14971)
- Risk Management plan development.
- Hazard identification and Risk Analysis.
- Risk control measures documentation.
- Overall residual risk evaluation.
- Complete risk management report.
Device Master File (DMF) & Plant Master File (PMF)
- Comprehensive DMF assembly for CDSCO.
- Manufacturing process documentation.
- Quality control procedures.
- Facility and equipment information.
- Supplier and material controls.
Essential Principles/GSPR Checklist
- Master compliance checklist for every Essential Requirement and GSPR.
- Requirement-by-requirement compliance justification.
- Evidence mapping and traceability.
- Harmonized standards compliance documentation.
Clinical Evaluation Report (CER)
- Clinical evaluation strategy development.
- Systematic literature review and analysis.
- Clinical data evaluation and synthesis.
- CER writing per MEDDEV 2.7/1 rev 4 and EU MDR requirements.
- PMCF planning and evaluation.
Biocompatibility Documentation
- Biological Evaluation planning per ISO 10993-1.
- Material characterization and chemical analysis.
- Test strategy development and lab coordination.
- Biological Evaluation report writing.
Sterilization Validation Documentation
- Sterilization validation protocol development.
- IQ/OQ/PQ documentation assembly.
- Sterility assurance level (SAL) validation.
- Final validation report preparation.