Saudi Arabia · SFDA
SUNGO supports SFDA registration and MDMA submissions, local authorised representation, technical documentation, responses to review questions, amendments and renewals.
311 MDMA certificates is SUNGO’s latest confirmed total. The 180+ project count is as of 30 June 2026. Past results do not guarantee approval of a new application.
Why SUNGO
SUNGO has helped clients obtain 311 Saudi MDMA certificates. Experience spans risk classes A–D and includes rehabilitation devices, dressings, catheters and active equipment, informing the assessment of documentation needs.
Registration personnel review device information, test reports and labeling, analyze SFDA questions and prepare response materials with clients and technical specialists. Testing issues are reviewed jointly with laboratory staff.
Local authorised representative services support communication with SFDA and assistance with complaints, remediation and post-market matters after the initial registration.
We help assess documentation needs for changes to models, brands and other registration details, and support amendments, renewals, UDI-related work and preparation for SFDA inspections.
Service scope
Choose individual services or a coordinated project based on your device and existing documentation.
Review intended use, technical characteristics and the model range.
Review existing certificates, test reports and device information; help address gaps.
Coordinate local representative services and project communication.
Prepare application information, check consistency and support submission.
Analyze review comments and coordinate explanations and additional evidence.
Support changes to models, brands and registration information, as well as renewals.
Working with SUNGO
The sequence is tailored to your project. Some activities may run in parallel.
Review intended use, technical features, models and existing documentation.
Assess classification, submission arrangements and documentation gaps.
Coordinate technical documents, test evidence and labeling.
Check application information and coordinate submission.
Analyze and address additional questions.
Support amendments, renewals and information updates.
Product experience
These are selected areas of project experience. Classification and submission requirements depend on each device’s intended use and technical characteristics.
Manual and powered wheelchairs, beds, walking aids and patient lifts.
Medical gloves, gauze, foam dressings and other consumables.
Intraoral scanners, nebulizers and related devices.
Syringes, infusion sets and central venous catheters.
Hair-removal devices and pneumatic compression devices.
Laryngeal masks, oxygen masks and tracheal tubes.
Client project experience
SUNGO’s international registration team has helped multiple clients obtain MDMA certificates for hair-removal devices. The work included documentation preparation and review correspondence based on each product’s characteristics. Contact our team to discuss the scope and information needed for your project.
List component names, quantities, materials, purposes and configuration differences for first-aid or procedure packs. Separate medical and non-medical components before assessing grouping and scope.
Compare anatomical site, purpose, design, materials and risk across models. A similar name or body site alone does not justify one application.
Map performance, biological, sterilisation and packaging evidence to contact type, duration and sterile claims. Reconcile component and pack labels, instructions and supplied configurations.
AR is the local representative role; ARL concerns representative licensing; MDMA concerns device marketing authorisation. Coordinate agreements, licensing and maintenance without treating an AR licence as product approval.
Support scope review, handover, changes and renewal arrangements, with regulatory enquiries, complaints and safety-information coordination. Assess handover conditions and previous-representative cooperation first.
Assess rehabilitation, dressings, urine and ostomy products, orthoses, protective products and dental devices against intended purpose and technology rather than assigning risk from the product name alone.
Grouping and documentation are assessed case by case. Existing overseas certificates and reports do not automatically establish SFDA acceptance.
SFDA · MDMA requirements ↗ · SFDA · Establishment licensing requirements ↗
Specific requirements are subject to product assessment and the competent authority’s current regulations.
Free initial consultation
Email the product name and instructions for use. Our team will respond within one business day to discuss the next steps.