CDSCOMedical Device LicenseConsultants
Get your CDSCO medical device license in record time. We handle MD5, MD9, MD15, MD13 & MD17 licenses with 100% success rate. Trusted by 500+ manufacturers and importers across India.
Complete CDSCO Medical Device Solutions
From manufacturing licenses to import permits and quality certifications, we provide comprehensive support for all your medical device regulatory needs.
Manufacturing Licenses
For Medical Device Manufacturers
Essential licenses for manufacturing medical devices in India
MD5 License
Manufacturing License for low to moderate risk devices (Application Form MD3)
- Manufacturing authorization for Class A & B
- Form MD3 application
- Regulatory compliance
- Documentation support
MD9 License
Manufacturing License for high risk devices (Application Form MD7)
- Manufacturing authorization for Class C & D
- Form MD7 application
- Quality assurance
- Facility compliance
MD13 License
Test License for Medical Devices (Application Form MD12)
- Test license authorization
- Form MD12 application
- Testing and evaluation
- Regulatory compliance
Import Licenses
For Medical Device Importers
Licenses required for importing medical devices into India
MD15 License
Import License for Medical Devices (Application Form MD14)
- Import authorization
- Form MD14 application
- Regulatory approval
- Compliance support
MD17 License
Import Test License for Medical Devices (Application Form MD16)
- Import test authorization
- Form MD16 application
- Testing and evaluation
- Regulatory compliance
Certificates
Quality & Compliance Certifications
Essential certifications for medical device businesses
FSC Certificate
Certificate proving medical device is freely sold in country of origin
- Free sale authorization
- Country of origin validation
- Export compliance
- Regulatory approval
MSC Certificate
Certificate for manufacturing site compliance and quality standards
- Site compliance validation
- Quality standards certification
- Manufacturing authorization
- Regulatory approval
NCC Certificate
Certificate indicating no regulatory objections to the medical device
- Regulatory clearance
- No objection validation
- Compliance certification
- Approval documentation
ISO 13485
International standard for quality management in medical devices
- Quality management system
- International standards compliance
- Process documentation
- Continuous improvement
Need Help Choosing the Right License?
Our experts will analyze your business requirements and guide you to the perfect solution. Get a free consultation and quote today.
Technical Documentation Support
Comprehensive preparation and review of all regulatory technical files for medical devices.
We help you compile, review, and maintain all essential technical documents required for CDSCO and international compliance.
Device Master File (DMF)
Complete preparation and review of DMF as per CDSCO and global requirements.
Plant Master File (PMF)
Preparation and gap analysis of PMF for manufacturing site compliance.
Essential Principles Checklist
Documentation and justification for all essential safety and performance principles.
Risk Management File (ISO 14971)
Risk analysis, evaluation, and control documentation as per ISO 14971.
Clinical Evaluation Report (CER)
Preparation and review of CER for clinical safety and performance evidence.
Labels & IFU Review
Review and compliance check for product labels and Instructions for Use (IFU).
Why Choose Us?
We combine regulatory expertise, speed, and transparency to help you succeed in the medical device market.
Expert Regulatory Team
Our consultants have deep CDSCO and global regulatory experience.
Fast & Reliable Processing
We expedite your application with proven workflows and strong agency relationships.
100% Compliance Guarantee
We ensure your application meets all CDSCO and international requirements.
24/7 Support
Get answers and guidance anytime from our dedicated support team.
What Our Clients Say
Trusted by hundreds of medical device businesses across India
"Register Medical Device helped us navigate the complex CDSCO regulations and obtain our MD9 license within the promised timeframe. Highly recommended!"
"The team at Register Medical Device made the MD5 license process smooth and hassle-free. Their expertise in regulatory compliance is outstanding."
"Professional service, transparent pricing, and excellent support throughout the MD13 license application process. They truly understand the industry."
Ready to Get Your Medical Device License?
Don't let regulatory hurdles slow down your business. Get expert guidance and expedited processing for all CDSCO licenses.