SFDA Authorized Representative: Mandatory Requirement for Foreign Manufacturers

1. Key takeaways

Wherever the manufacturer has no legal entity established in Saudi Arabia, an AR (Authorized Representative) must be appointed before an MDMA application can be completed. Article 1 of M/54 defines the AR as a legal entity located within Saudi Arabia, holding written authorisation from the foreign manufacturer, acting on its behalf to implement the law and the regulation. The AR is not a nominal agent: it is the statutory contact point between the Manufacturer and SFDA, with duties including adverse event reporting, traceability cooperation and designation of the responsible SFDA liaison. Chinese manufacturers most often underestimate the processing time of the AR licence and the notarisation and legalisation chain — both frequently finish later than the technical documentation and decide whether the GHAD submission can be filed at all. The publicly cited AR licence fee is SAR 2,600 per contract per year (practical estimate).

• Article 1 of M/54 confines the AR to a legal entity in Saudi Arabia with written authorisation from the foreign manufacturer.
• The AR itself must first obtain an SFDA licence; signing an agreement alone is not enough.
• The publicly cited AR licence fee is SAR 2,600 per contract per year, plus 15% VAT (practical estimate).
• The notarisation and legalisation chain runs home-country notarisation, Foreign Ministry attestation, then Saudi embassy legalisation; a missing step means GHAD will not accept the file.
• MDS-REQ 11 V2.0 obliges the manufacturer and the AR to report adverse events and complaints to the NCMDR and to designate responsible SFDA liaison persons.

2. Legal basis

The table traces the AR obligations back to their sources, from the definition in the Law to the reporting duties in the post-market requirements.

3. Expert insights

Why Saudi Arabia confines AR eligibility to a domestic legal entity

The M/54 definition of the AR carries three qualifiers: located within Saudi Arabia, a legal entity, and written authorisation from the foreign manufacturer. All three are indispensable and reveal the regulatory logic — SFDA needs a subject that can be served locally, held accountable and inspected. This is stricter than the EU MDR’s EC-REP: MDR Article 11 only requires the authorised representative to be established in the EU, and a natural or legal person is theoretically permissible. The US FDA requires a U.S. Agent for foreign firms, limited to communication and receipt of information, not extending to post-market reporting duties. China’s NMPA requires foreign registrants to appoint a Chinese enterprise legal person as responsible party, the closest parallel in scope to the Saudi AR, but Saudi Arabia adds an independent AR licence. The consequence is direct: the AR does not take office on a signed agreement; it must first obtain its own SFDA licence.

The practical impact on Chinese manufacturers: the AR decides whether you can file, not merely who files

GRZAN’s scheduling experience is that three AR workstreams must start in parallel with the technical documentation. First, vetting the AR entity’s qualification — whether it holds a valid Establishment licence covering the product category. Second, signing the AR agreement and running the notarisation and legalisation chain: home-country notarisation, Ministry of Foreign Affairs attestation, Saudi embassy legalisation. Third, completing the AR fields in the MDMA application and obtaining the Establishment Number (MDS-G030 Step 1 expressly requires opening an account on the SFDA E-Services portal). Run in series, these three items usually close later than the technical file. Another frequently ignored knock-on effect is data ownership: MDS-REQ 7 V4.0 requires UDI data to be submitted and maintained in Saudi-DI by the manufacturer or the AR; if the AR lacks data maintenance capability, post-market model changes and UDI-DI updates will break the chain.

The AR duty list: from adverse events to final destruction

The AR’s obligations are scattered across several documents and group into four. First, report any adverse event and complaint to the NCMDR, follow up the investigation and provide all documents, within deadlines of 2 days for a serious public health threat, 10 days where death or serious deterioration is possible, and 30 days otherwise. Second, trace devices at SFDA’s request and maintain a tracking system recording supply and distribution information. Third, designate a responsible SFDA liaison person, on the same footing as manufacturers, importers and distributors. Fourth, cooperate in the post-market stages of resale, lending and donation of second-hand devices, after-sales maintenance and destruction of discarded devices. By comparison, the EC-REP’s core duties are to keep a copy of the technical documentation and cooperate with the competent authority, without directly carrying vigilance reporting; the U.S. Agent bears no such duties at all. Choosing an AR in Saudi Arabia is therefore in substance choosing a local compliance partner able to carry vigilance business, not a mailing address.

The notarisation and legalisation chain of the AR agreement is described at https://www.grzan.cn/regulations/saudi/ar-agreement-legalization-chain-32 , and the AR licence duty list at https://www.grzan.cn/regulations/saudi/authorized-representative-licensing-and-duties-31 .

4. Practical recommendations

• Start AR screening alongside the technical documentation, vetting whether the Establishment licence scope covers the product category; do not wait until just before filing.
• The AR agreement must fully embody the three elements — a domestic legal entity, written authorisation, and implementing the law and regulation on the manufacturer’s behalf — with clauses on vigilance cooperation, document retention and traceability.
• Allow time for the notarisation and legalisation chain — home-country notarisation, Ministry of Foreign Affairs attestation, Saudi embassy legalisation; a missing step means GHAD will not accept the submission.
• Open the SFDA E-Services portal account early to obtain the Establishment Number (MDS-G030 Step 1), so it does not become the final bottleneck.
• Agree in writing with the AR on the division of Saudi-DI data maintenance: name the persons responsible for model names, GMDN codes and UDI-DI.
• Define vigilance reporting responsibilities: the AR must complete NCMDR reports within the 2-day, 10-day and 30-day deadlines and answer NCMDR follow-up within 5 days.
• Budget the AR licence fee at SAR 2,600 per contract per year (Saudi Riyal, SAR) plus 15% VAT (practical estimate); in practice the GHAD invoice governs.
• The AR-related item numbers of MDS-REQ1 Article 4 and MDS-REQ9 were not obtained one by one in this review; download the current versions and verify before submission (practical estimate).

5. Verification checklist

• □ Confirmed the company has no Saudi legal entity and must appoint an AR
• □ AR is a legal entity located in Saudi Arabia holding a valid Establishment licence
• □ AR agreement contains the elements: domestic legal entity, written authorisation, and implementation of the law and regulation on the manufacturer’s behalf
• □ All three steps of the notarisation and legalisation chain completed (notarisation, Foreign Ministry, Saudi embassy)
• □ SFDA E-Services account created and Establishment Number obtained
• □ Saudi-DI data maintenance responsibilities agreed in writing with the AR
• □ Vigilance reporting mechanism rehearsed, the three deadlines (2, 10 and 30 days) written into the SOP
• □ AR licence fee budgeted at SAR 2,600 per year plus 15% VAT (practical estimate)
• □ AR-related item numbers of MDS-REQ1 Article 4 and MDS-REQ9 verified against current downloaded versions

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Saudi Arabian market. Our team manages SFDA medical device marketing authorisations and Saudi Authorized Representative arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com