SFDA Requirements for Medical Device Marketing Authorization
The Saudi Food and Drug Authority (SFDA) oversees the regulation of medical devices and In Vitro Diagnostics (IVDs) in Saudi Arabia. To bring medical devices, including IVDs, to market in the Kingdom of Saudi Arabia (KSA), a Medical Device Market Authorization (MDMA) from the SFDA is mandatory. The SFDA rigorously evaluates MDMA applications before granting approval.
Navigate the Medical Device Regulatory Landscape in Saudi Arabia with MedDev Experts
MedDev Experts, with our team of seasoned professionals, is committed to providing comprehensive support for your medical device registration in the KSA. We are here to guide you through every step of the process, ensuring a smooth and efficient registration journey.
Comprehensive Medical Device Technical Documentation for Marketing Authorization
Clearly present the technical documentation in an organized, readily searchable, and unambiguous format, encompassing the following essential elements:
1. Device Description and Specification, Including Variants and Accessories
This section should provide a comprehensive overview of the device, including:
- Product or trade name
- Product code
- Model number
- Catalogue number
- Physical description
- Details about components, parts, spares, and accessories
- Materials
- Principles of operation/mode of action
- Images or drawings of the device
- Intended purpose
- Intended users
- Classification of the device
This section should provide a comprehensive overview of the device label, including:
- Device labels and packaging
- Instructions for use (IFU)
- Storage condition
- Barcodes (UDI)
- The advertising and marketing material to be provided in both Arabic and English language.
3. Design and Manufacturing Information
This section should provide a comprehensive overview of the device design and manufacturing information, including:
- Technical drawings
- Bill of materials
- Information to describe the function and assembly of the device
- Device features
- Dimensions
- Performance attributes
- Voltages
- Output
- Temperatures
- Flows
- Weight
- Speed
- User requirements
- Product requirements
- Software requirements
- Hardware requirements
- Design Traceability
- Design Stages
- Manufacturing processes
4. Essential Principles of Safety and Performance
This section should demonstrate how the manufacturer has met the essential principles of safety and performance of the device.
This section should provide a comprehensive overview of the benefit to risk assessment and demonstrates that the device is considered safe. The risk analysis and risk management of the device should include:
- Risk Analysis
- Risk Evaluation
- Risk Control
- Production & Post-production information
- Risk Management Plan
- Risk Analysis
- Risk Management Report
6. Product verification and validation
This section should provide a comprehensive overview of the methods and standards used to verify and validate the product including:
- Results of tests, such as engineering, laboratory, simulated use and animal tests
- Biocompatibility of the device
- Physical, chemical and microbiological characterisation
- Stability, including shelf life
- Performance and safety
- Clinical evaluation report
7. Post Market Surveillance Plan
This section should provide a comprehensive overview of the systems are in place to ensure appropriate post market surveillance data is collected. This section shall include:
- Sources of potential post market surveillance data
8. Periodic Safety Update Report and Post Market Surveillance Report
This section should provide a comprehensive overview of the periodic analysis of the safety of the device including:
- Post-market surveillance report
- Periodic safety update report
Are you looking for an easy way to get your medical device approved in Saudi Arabia?
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We have created ready-to-use templates for medical device technical files that are tailored to meet SFDA requirements. Our templates will save you time and resources and help you get your device approved quickly and easily.
Whether you’re a seasoned professional or new to the regulatory landscape, our templates are easy to use and will provide you with the information you need to submit a successful application.
Contact MedDev Experts today to learn more about our ready-to-use medical device technical file templates!
Ready-to-Use Technical File for Medical Device Registration with SFDA
We provide ready to use technical file for medical device registration with SFDA
Features:
- Pre-formatted and easy-to-use templates
- Tailored to meet SFDA requirements
- Covers all aspects of technical file documentation
- Saves time and resources
- Suitable for both experienced and novice users
Benefits:
- Increased efficiency and productivity
- Reduced risk of errors and omissions
- Improved chances of success in SFDA submissions
- Enhanced compliance with SFDA regulations
MedDev Experts: Your Gateway to Medical Device Marketing Authorization in Saudi Arabia
MedDev Experts, a leading global consultancy specializing in medical devices and In Vitro Diagnostics (IVDs), empowers companies to secure approvals in Saudi Arabia. Our team of seasoned experts possesses in-depth knowledge of the SFDA registration process and is committed to providing comprehensive support throughout your journey.
How We Can Help You Achieve Success:
- Expert Classification Guidance: We assist in accurately classifying your medical device and IVD, ensuring alignment with the SFDA’s classification system.
- SFDA Liaison Services: We act as your Authorized Representative, streamlining communication with the SFDA and ensuring compliance throughout the process.
- MDMA Application Support: We expertly prepare and submit your Medical Device Marketing Authorization (MDMA) application, guiding you through the intricacies of the submission process.
- Import Authorization Assistance: We provide comprehensive guidance on the documentation required for import authorization, alleviating the complexities associated with market entry.
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MedDev Experts
Collaborate with MedDev Experts to navigate regulatory landscapes and pave the way for successful sales in Saudi Arabia and various international markets. Our expertise and commitment to excellence will ensure a seamless and efficient registration process, propelling your business forward.
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