Hold the registration
A Medical Device Marketing Authorisation is issued to a Saudi-licensed Authorised Representative, not to a foreign manufacturer. The AR carries the regulatory file, the approved labelling and the liability that goes with it.
For manufacturers & suppliers
Saudi Arabia is building laboratory capacity faster than most manufacturers can register for it.
Vision 2030 has expanded hospital, reference-laboratory and polyclinic capacity across the Kingdom, and NUPCO now channels a unified procurement budget of over SAR 25bn through more than 500 public facilities. Every device and IVD entering that market needs current SFDA approval held through a Saudi-licensed Authorised Representative. Afiyatech is that route — registration, warehousing, distribution and the account relationships, run from Riyadh.
25,000 sq ft, RiyadhFEFO rotation, 2–8 °C and −20 °C cold storage, lot-level traceability.
SAR 25bn+NUPCO’s unified procurement channel — open only to suppliers with verified SFDA status and a compliant local supply chain.
500+Public healthcare facilities buying through that channel, alongside a fast-growing private hospital and polyclinic sector.
2030The Vision 2030 health programme continues to add laboratory capacity and push CBAHI, JCI and CAP accreditation.
SFDAMDMA approval via a licensed Authorised Representative is mandatory. Without one, a manufacturer has no legal route to the market.
Why a resident partner is not optional
Three things a manufacturer cannot do from outside the Kingdom
Saudi Arabia is not a market you can serve on export documentation alone. Registration, procurement access and post-market obligations all require a licensed party inside the country.
Hold the stock
Buyers plan around Riyadh availability, not shipping schedules. Without local inventory under FEFO and cold-chain control, a product loses tenders on lead time alone.
Carry the post-market load
Complaint handling, lot traceability, recall execution and field safety corrective action reporting all have to happen locally, in Arabic, to SFDA timelines.
Who you would be working with
Fourteen years in the Saudi market, and the infrastructure behind it
Afiyatech has supplied laboratories in the Kingdom since 2012. The distribution, warehousing and account relationships already exist — a new line joins a running operation rather than starting one.
Warehousing25,000 sq ft in Riyadh, FEFO-managed.
Cold chain2–8 °C and −20 °C, monitored.
DistributionNationwide, plus the sub-distributor network.
Accounts80+ hospital, laboratory and polyclinic accounts.
80+Hospital, reference-laboratory, polyclinic and specialist-centre accounts under direct management.
2012Trading in Saudi laboratory supply since 2012, through the SFDA registration regime and the shift to NUPCO.
25,000Square feet of Riyadh warehousing, with 2–8°C and −20°C cold storage, FEFO rotation and lot-level traceability.
30+International manufacturers already distributed across the six supply pillars.
Reference partnership: Afiyatech is an authorised distributor for Copan in Saudi Arabia, covering UTM®, eSwab®, FecalSwab™, FLOQSwabs® and SRK®. See the full manufacturer list.
How a partnership is structured
Two stages: market entry first, national exclusivity once it is earned
We do not ask for exclusivity before either side has evidence. A partnership opens with a defined three-month entry stage on one product line, and converts on a result.
Stage one
Market entry
Three months, one agreed product line, non-exclusive. You keep your options open; we prove we can move the product.
- Introduction to named hospital and reference-laboratory accounts, with your product put in front of the people who specify it
- Import clearance, customs handling and the Saudi documentation set prepared on your behalf
- Commercial feedback from the accounts we approach — pricing, format and competitor position
- No exclusivity asked for, and none given, during the entry stage
Stage two
National exclusivity
A full national distribution agreement. Everything in stage one, plus the whole operation behind it.
- SFDA MDMA registration and Authorised Representative sponsorship, held and maintained by Afiyatech
- Riyadh warehousing with FEFO rotation, 2–8°C and −20°C cold chain and lot-level traceability
- NUPCO and government tender access, with the compliance file that participation requires
- Nationwide distribution and the sub-distributor network beyond the capital
- Clinical evaluation and pilot validation with KOL laboratories
- Arabic labelling, IFU translation and local marketing
- Post-market surveillance, complaint handling, recalls and FSCA reporting
What moves you from stage one to stage two: the first hospital tender or account win. That is the trigger — not a revenue target, not a review meeting.
The market-entry process
From first conversation to first shipment
Five stages, with indicative durations. The regulatory step dominates the timeline, so we start it as early as your documentation allows.
01
Product review & NDA
1 – 2 weeks
We review your catalogue, regulatory status and pricing against the six pillars and tell you honestly whether there is a Saudi position for it.
02
AR appointment
2 – 4 weeks
Authorised Representative agreement signed and the regulatory file assembled — quality certificates, free-sale certificate, labelling and IFU.
03
SFDA submission & review
3 – 6 months
MDMA application filed and managed through review, including any queries raised. Duration depends on device class and file completeness.
04
Stock, pricing & first shipment
4 – 6 weeks
Pricing agreed, initial order placed, cold-chain and FEFO parameters set, stock landed and received into Riyadh.
05
Accounts, pilots & tenders
Ongoing
Introduction to accounts, pilot evaluation at KOL laboratories where the product warrants it, and entry into tender cycles.
SFDA
MDMA & AR regime
NUPCO
Unified procurement
CE (MDR / IVDR)
Accepted route in
US FDA
Accepted route in
Durations are indicative planning guidance, not commitments. SFDA publishes a target of 35 working days to review a validated MDMA technical file; real-world timelines run longer where the device class is higher or the file raises queries. MDMA approvals are issued for a fixed term and must be renewed. Timelines are confirmed per device once we have your documentation. Sources: SFDA MDMA/GHAD guidance (2026) — see Evidence.
What we look for
The six things we check before taking on a line
We represent products we can defend in a laboratory and at an audit. Meeting these does not guarantee a partnership, but not meeting them makes one unlikely.
CE mark or US FDA clearance
A current CE certificate under MDR/IVDR, or FDA clearance or approval. This is the foundation of the SFDA file — without it there is little to submit.
Certificate of Free Sale
Issued by the competent authority in your country of origin, confirming the product is legally marketed there.
Reference installations
Existing use in the GCC or a comparable regulated market. Saudi laboratories ask who else runs it, and they check.
Willingness to grant exclusivity
Not on day one — but at stage two. We invest in registration and account development on the understanding that the national position is ours to build.
Support for pilot stock and training
Evaluation quantities and application training for the laboratories running the pilot. A product that cannot be trialled cannot be standardised.
Pricing that survives a tender
A committed structure that holds up against NUPCO and private-group tender pricing, with the volume tiers written down before we quote.
OEM enquiries welcome. Where the regulatory file supports it, we will consider Afiyatech-branded supply. Say so in your enquiry and we will tell you early whether it is viable.
What we are looking to add
Leading manufacturers with equivalent or better products across the six pillars
Our interest is in strengthening the six categories we already supply and filling the gaps inside them — formats we cannot currently offer, price points we cannot reach, and platforms our accounts run but we do not yet carry. If your product sits in one of these, start there.
Copan specimen collection
Clinical chemistry & haematology
Rapid & POCT diagnostics
Immunoassay analyser reagents
Preanalytics: blood & specimen
Infection control, PPE & equipment
Browse the full 104-product catalogue to see exactly what we carry today and where a gap sits.
Partnership enquiry
Tell us what you make.
We reply within one working day with an honest read on whether there is a Saudi position for your product, what registration would involve and what the first stage would look like. Commercial terms are a conversation, not a web page — nothing here commits either side.
Talk to us directly
Send the catalogue. We will tell you whether it has a Saudi position.
If you would rather open with a conversation than a form, email or call the Riyadh office. We will look at your range against what our 80+ accounts already run and give you a straight answer on the gap.
Zaid Ibn Thabit, Al Malaz District, Riyadh, Saudi Arabia
+966 58 121 8534
contact@afiyatech.com
www.afiyatech.com