Authorized Representative Licensing and Duties in Saudi Arabia

1. Key takeaways

The Saudi Arabian Authorized Representative (AR) is a legally defined role: a legal entity located within Saudi Arabia, holding written authorization from the foreign manufacturer to perform the Law of Medical Devices and Supplies on its behalf. The AR licence is issued by the SFDA under Law M/54, counted per contract; practical estimate SAR 2,600 per contract per year plus 15% VAT. AR duties go beyond filing applications: MDS-REQ 11 V2.0 places the AR, the manufacturer and healthcare institutions in one obligation sequence, reporting adverse events and complaints to the NCMDR within 2, 10 or 30 days, with replies to NCMDR follow-ups due within 5 days. GRZAN treats the AR as a continuously operating compliance channel, not a one-off stamping vendor.

• Two independent requirements: an in-country legal entity and written authorization from the foreign manufacturer.
• The AR licence is counted per contract; practical estimate SAR 2,600 per contract per year plus 15% VAT.
• Adverse event and complaint reporting timelines of 2, 10 and 30 days, and 5 days to answer NCMDR follow-ups.
• The AR licence is billed through GHAD; the invoice amount prevails.
• Agreements should allocate vigilance duties, deadlines and account ownership before signature.

2. Legal basis

The table below lists the instruments cited. Items marked as a practical estimate have not been verified against an official SFDA fee schedule and remain pending verification against GHAD billing.

3. Expert insights

1. In-country legal entity and written authorization are two independent requirements. Article 1 of Law M/54 states both requirements side by side. The first half answers jurisdiction: the SFDA needs an in-country party it can serve, inspect and hold accountable. The second half answers authenticity and scope: the foreign manufacturer must state who is authorized and to do what. The most common failure covers only half: the authorization letter is signed by an overseas trading company rather than the legal entity itself, or the in-country entity’s registered business activities do not cover medical devices. GRZAN checks the commercial registration against the SFDA Establishment Number, plus the authorization letter’s signatory, scope and validity. Reliance projects (MDS-G030 V1.0) cannot skip this step, since reliance shortens review timelines, not entity eligibility.

2. The AR licence is counted per contract, so one licence does not cover everything. The billing unit is per contract per year (practical estimate SAR 2,600 plus 15% VAT), and the unit reveals the assumption: one foreign manufacturer, one AR contract, one AR licence. A group with several independent legal entities each holding an MDMA must sign separate authorizations, obtain separate licences and pay separately. Conversely, one in-country AR may serve several foreign manufacturers, each with a separate authorization and licence record. Some sources indicate validity options of 1 to 10 years (practical estimate), shaping multi-year cost modelling: annual payment and a long upfront term give very different cash flows. Terms and rates follow the GHAD billing statement.

3. AR obligations truly begin after the device is on the market. MDS-REQ 11 V2.0 sets enforceable duties for the AR: report adverse events and complaints to the NCMDR and follow up investigations, trace devices at the SFDA’s request, build a tracking system for supply and distribution data, document event follow-up procedures, and designate an SFDA contact person. Timelines are hard: 2 days for a serious public health threat; 10 days where death or serious injury may directly or indirectly result or be contributed to; 30 days otherwise; replies to NCMDR follow-ups within 5 days; investigation and final reports at 15, 30 and 60 days. The AR is thus the de facto responsible party in Saudi Arabia, so the agreement must allocate vigilance duties, deadline ownership and reporting accounts before signature.

4. Comparison with other markets. The EC-REP under the EU MDR was long treated as a nominal responsible person, with duties significantly increased after the MDR; the UKRP and CH-REP follow similar designs. Saudi Arabia differs in writing AR duties into specific MDS-REQ 11 provisions with reporting timelines, tying them directly to the NCMDR and Saudi Vigilance channels, and requiring a separate licence and separate fees. The Australian AR (sponsor) centres on including devices in the ARTG. For Chinese manufacturers with EC-REP experience, the main increments are a separately licensed entity, separate fees and a separate post-market interface, so the same agreement text cannot be reused.

The AR’s full post-market surveillance obligations pair with https://www.grzan.cn/regulations/saudi/post-market-surveillance-ncmdr-and-saudi-vigilance-41 ; for AR change and MDMA certificate ownership, see https://www.grzan.cn/regulations/saudi/authorized-representative-transfer-and-mdma-change-33 .

4. Practical recommendations

• Verify entity eligibility: confirm the proposed AR is a Saudi legal entity whose commercial registration covers medical device activities, matching its SFDA Establishment Number.
• Build an authorization letter checklist: signed by the foreign manufacturer’s legal entity, stating device scope, authorized matters, effective date and termination conditions, dispute handling and record handover after termination.
• Keep a ledger per contract: submit the AR licence application in GHAD under MDS-REQ 9, recording contract number, licence number, validity, receipts and renewal reminders.
• Pay via SADAD per the GHAD billing amount including 15% VAT, retain receipts and archive them against the contract number.
• Write the post-market interface into the agreement: NCMDR reporting duties, internal triggers for the 2/10/30 day timelines, the 5 day response owner, and retention and handover of investigation files.
• Designate and back up contacts: the AR designates the SFDA contact person; the manufacturer keeps a backup, updated in writing and synchronized in GHAD when staff change.
• Review annually: check that AR licence validity and contract term stay aligned, so an expired licence does not block MDMA changes or renewals.
• Ask the authorities when uncertain: SFDA offers free technical support via call centre 19999 and md.rs@sfda.gov.sa; keep answers on file.

5. Verification checklist

• □ Proposed AR is a Saudi legal entity whose commercial registration includes medical device activities
• □ A written authorization letter signed by the foreign manufacturer’s legal entity is in hand, with scope matching the device list
• □ The AR licence has been submitted in GHAD under MDS-REQ 9 and a licence number obtained
• □ Fees budgeted at SAR 2,600 per contract per year (practical estimate) plus 15% VAT
• □ SADAD payment receipts archived, amounts matching the GHAD billing statement
• □ Adverse event reporting duties, timelines and contacts between AR and manufacturer documented in writing
• □ The AR has designated an SFDA contact person and the manufacturer holds a backup contact
• □ Post-market procedures documented, covering traceability, the tracking system and event follow-up
• □ AR licence validity aligned with the authorization letter validity, with renewal reminders set
• □ Current version numbers of MDS-REQ 9 and MDS-REQ 11 checked on the SFDA website

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 coordinates Saudi Authorized Representative arrangements, import licences, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com