Saudi Arabia
SFDA Medical Device Marketing Authorization
MDMA-2-2026-4108
Issued 25 August 2026 · valid to 25 August 2029 · medical device marketing authorization for the electric wheelchair product family.
Open the authorization PDF ↗Credentials archive
Electric wheelchair certifications and compliance files.
Four documents are published here because they exist and can be opened: a Saudi SFDA marketing authorization, a CE declaration of conformity, an ISO 13485 certificate and an FDA facility registration and device listing record. Below them is the list of files we can supply for a specific order, and an explicit statement of what each document does not establish.
Documents we hold
Published files, open for review.
No document on this page is a placeholder.
European Union
CE Declaration of Conformity
Document on file
Declaration of conformity issued for the model range stated on the document. Scope and the standards cited are shown on the file itself.
View the declaration ↗Quality management
ISO 13485 certificate
Certificate and scope on file
Quality management system certificate for medical device manufacture, two pages including the certified scope.
View the certificate ↗United States
FDA facility registration and device listing information
Registration and listing record
Facility registration and device listing information only. This is not an FDA approval, clearance or endorsement, and we do not describe it as one.
View the registration record ↗Reading a certificate correctly
What each document establishes, and what it does not.
| Document | What it supports | What it does not establish |
|---|---|---|
| SFDA marketing authorization | Market access for the covered device family in Saudi Arabia, for the period printed on the document. | Authorization for any other country, or for models outside the stated scope. |
| CE declaration of conformity | The manufacturer’s declaration that the listed models meet the cited EU requirements, signed by the manufacturer. | A notified body certificate unless the document itself is one, or coverage of accessories added after issue. |
| ISO 13485 certificate | An audited quality management system covering the certified scope of manufacture. | A product approval. It says nothing about the performance of a specific unit. |
| FDA registration and listing | That a facility and device listing exist in the FDA database. | FDA approval, clearance, or permission to market. It is not a 510(k) clearance. |
Available on request
Files we can supply for a specific order.
These are produced or collated per order rather than published as a standing archive. Ask for them with the model and destination market, and we will confirm what exists for that configuration before quoting.
- Model specification sheet for the exact configuration you are ordering
- Material and finish declaration for the frame, fasteners and upholstery
- Packing specification and container loading plan for the quantity quoted
- Pre-shipment inspection record and the checklist used for that shipment
- Product label and marking content required by your market, agreed before production
- Battery transport documentation required by the carrier for the shipping method used
- Declaration of conformity scope confirmation where a private label is requested
If a document you need is not on either list, ask. If we do not hold it, we will say so rather than describe something we cannot produce.
What we will not claim
We do not describe the FDA record as an approval, clearance or endorsement.
We do not quote certificate numbers for documents we have not published.
We do not claim market authorization for countries where the file is not held.
We do not present a laboratory coupon test as a test of the finished electric wheelchair.
Need the file package for your market?
Send the model, destination country and whether the order is under your brand. We will reply with the documents that exist for that configuration.