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Read our comprehensive, step-by-step guides for all CDSCO medical device licenses. Each guide includes complete application process, required documents, fees, and compliance tips.
CDSCO Medical Device Licenses
Comprehensive licensing solutions for manufacturing, importing, and testing medical devices in India.
CDSCO MD5 License
Manufacturing License for Class A & B Medical Devices
Manufacturing license for low to moderate risk medical devices. This license is required for manufacturing Class A and B medical devices in India using Application Form MD3.
What We Provide
- Manufacturing authorization for Class A & B devices
- Application Form MD3 processing
- Regulatory compliance with CDSCO
- Quality management system setup
- Facility compliance certification
- Documentation and paperwork support
Requirements
- Manufacturing facility with proper infrastructure
- Quality management system (ISO 13485)
- Technical personnel with relevant qualifications
- Equipment and machinery for manufacturing
- Quality control laboratory setup
- Documentation and records management
Get CDSCO MD5 License Today
CDSCO MD9 License
Manufacturing License for Class C & D Medical Devices
Manufacturing license for high-risk medical devices. This license is required for manufacturing Class C and D medical devices in India using Application Form MD7.
What We Provide
- Manufacturing authorization for Class C & D devices
- Application Form MD7 processing
- Enhanced quality assurance systems
- Advanced facility compliance certification
- Product registration support
- Manufacturing process validation
Requirements
- Advanced manufacturing facility
- Comprehensive quality management system
- Highly qualified technical personnel
- State-of-the-art equipment and machinery
- Advanced quality control laboratory
- Extensive documentation and records
Get CDSCO MD9 License Today
CDSCO MD13 License
Test License for Medical Devices
Test license for medical devices. This license allows testing and evaluation of medical devices using Application Form MD12.
What We Provide
- Test license authorization
- Application Form MD12 processing
- Testing and evaluation services
- Regulatory compliance support
- Documentation management
- Quality assurance for testing
Requirements
- Testing facility with proper equipment
- Qualified testing personnel
- Quality management system
- Testing protocols and procedures
- Documentation system
- Regulatory compliance procedures
Get CDSCO MD13 License Today
CDSCO MD15 License
Import License for Medical Devices
Import license for medical devices. This license is required for importing medical devices into India using Application Form MD14.
What We Provide
- Import authorization for medical devices
- Application Form MD14 processing
- Regulatory compliance with CDSCO
- Custom clearance assistance
- Quality assurance requirements
- Post-import compliance monitoring
Requirements
- Valid business registration
- Import-export code (IEC)
- Quality management system
- Technical documentation
- Bank guarantee
- Infrastructure requirements
Get CDSCO MD15 License Today
CDSCO MD17 License
Import Test License for Medical Devices
Import test license for medical devices. This license allows importing medical devices for testing purposes using Application Form MD16.
What We Provide
- Import test authorization
- Application Form MD16 processing
- Testing and evaluation services
- Regulatory compliance support
- Documentation management
- Quality assurance for testing
Requirements
- Testing facility with proper equipment
- Qualified testing personnel
- Quality management system
- Testing protocols and procedures
- Documentation system
- Regulatory compliance procedures
Get CDSCO MD17 License Today
Quality & Compliance Certificates
Essential certifications for medical device businesses to ensure quality and regulatory compliance.
FSC Certificate
Free Sale 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
Market Standing Certificate
Certificate proving market standing and commercial viability of the medical device
- Market standing validation
- Commercial viability proof
- Business reputation certification
- Market presence verification
NCC Certificate
Non Conviction Certificate
Certificate indicating no criminal convictions or regulatory violations
- Criminal record clearance
- Regulatory compliance verification
- Legal standing certification
- Clean record validation
ISO 13485
Quality Management System (Optional)
International standard for quality management in medical devices (not mandatory for CDSCO)
- Quality management system
- International standards compliance
- Process documentation
- Continuous improvement
Our Simple 5-Step Process
We make the licensing process simple and transparent
Initial Consultation
Free consultation to understand your requirements and assess eligibility
Documentation Preparation
We help you prepare all required documents and applications
Application Submission
Submit your application to CDSCO with our expert guidance
Follow-up & Monitoring
Track your application progress and handle any queries
License Issuance
Receive your license and start your medical device business
Ready to Start Your Medical Device Business?
Get expert guidance for any CDSCO license type. Our team is ready to help you navigate the regulatory landscape.