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I will support sfda medical device registration in saudi arabia
Naveed A
Level 2
About this gig
Need to register or update a medical device in Saudi Arabia?
I provide SFDA medical device registration and Medical Device Marketing Authorization (MDMA) support for manufacturers, distributors and companies entering the Saudi market.
Services include:
- SFDA device classification & regulatory pathway assessment
- MDMA registration requirements & application support
- Technical documentation & gap review
- ISO 13485, CE/FDA & document review
- Labeling & IFU compliance review
- Saudi Authorized Representative (LAR/AR) guidance
- MDMA application preparation & submission support
- SFDA query response support
- MDMA updates, renewals & post-registration support
I provide practical support based on your device, intended use and documents, helping you understand SFDA requirements for the Saudi market.
Disclaimer: I provide regulatory guidance based on client-provided information and documents. SFDA approval is subject to requirements and SFDA's final decision. LAR/AR services, SFDA/government fees, testing, translation and other third-party costs are excluded unless agreed.
Please contact me before ordering so I can review your device and recommend the right package.
Get to know Naveed A
Naveed A
Medical Device Regulatory and QMS Consultant
Level 2
- FromPakistan
- Member sinceNov 2022
- Avg. response time1 hour
- Last delivery3 weeks
Languages
Urdu, English
Medical Device Regulatory and QMS Consultant with 20+ years of experience. I support medical device companies with FDA registration and listing, 510(k), EU MDR, UKCA, ISO 13485 QMS, ISO 14971 risk management, technical documentation, risk files, CER, IFU, SOPs, validation, CAPA, SCAR, audits, and regulatory compliance. I deliver practical, accurate, and audit-ready documentation tailored to your product, regulatory pathway, and business needs.
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FAQ
1. Can you determine whether my medical device needs SFDA registration?
Yes. I can review your product, intended use, manufacturer information and available documentation to assess the applicable SFDA regulatory pathway and registration requirements.
2. Can you determine the SFDA classification of my device?
Yes. I can perform a preliminary classification assessment based on the device's intended purpose, characteristics and applicable SFDA classification rules.
3. Do I need a Saudi Authorized Representative?
Requirements depend on the manufacturer's location and regulatory situation. I can explain the applicable LAR/AR requirements and help you understand the responsibilities involved.
4. Can you review my existing technical documentation?
Yes. I can perform a regulatory gap review of available technical documentation, labeling, IFU, ISO 13485 and other supporting documents.
5. Can you help with an existing MDMA registration?
Yes. I can provide guidance for applicable updates, renewals, changes and post-registration regulatory requirements.
6. Do your prices include SFDA government fees?
No. SFDA/government fees, LAR fees, translation, testing and other third-party costs are excluded unless specifically stated in the selected package.
7. Can you guarantee SFDA approval?
Regulatory approval cannot be guaranteed because the final decision rests with SFDA. I provide professional regulatory support intended to help prepare a complete and compliant submission.
8. Can you support SFDA queries after submission?
Yes. Depending on the selected package, I can support the review of SFDA comments and assist with preparing appropriate responses and supporting documentation.
