Authorized Representative Transfer and MDMA Change

1. Key takeaways

The official position in MDS-G011 Part 3 is that the SFDA issues the MDMA certificate in the name of the manufacturer. The rights holder of the MDMA is therefore the foreign manufacturer, not the AR: changing the AR does not invalidate the certificate, and there is no legal act of transferring it from the old AR to the new one. What must be done is to update the authorized representative information for that MDMA in GHAD and obtain an independent AR licence for the new AR. AR licences are counted per contract, at a practical estimate of SAR 2,600 per contract per year plus 15% VAT; if the change also touches the legal manufacturer’s name or address, it may be treated as a major change charged at the full fee, while minor changes are set at SAR 5,000. GRZAN’s assessment: the technical difficulty is low, and the risk concentrates in the vigilance gap period and record handover.

• The MDMA certificate is issued in the manufacturer’s name, so changing the AR is not a certificate transfer.
• The new AR must hold its own AR licence before being linked to the MDMA in GHAD.
• AR licence: SAR 2,600 per contract per year plus 15% VAT (practical estimate).
• Minor changes SAR 5,000; legal manufacturer changes may be charged at the full fee.
• The main risk is a duty gap between old and new AR for NCMDR reporting.

2. Legal basis

The table below lists the instruments cited for AR transfer and MDMA changes; items marked as a practical estimate are pending verification against GHAD billing invoices.

3. Expert insights

1. Issued in the manufacturer’s name means an AR change is not a certificate transfer. This statement in MDS-G011 Part 3 is the foundation of the operation: the MDMA holder is always the foreign manufacturer, and the AR’s role on the certificate is the contact and responsibility entry point, not a rights holder. Three conclusions follow: changing the AR requires no full technical review and no certificate transfer procedure; the old AR cannot hold the certificate hostage, holding no certificate rights; and the new AR must obtain its own licence before being linked to the MDMA in GHAD. Conversely, if the change touches the legal manufacturer itself, for example a group moving production from company A to B, that is a manufacturer change, usually at the full fee and a different workload scale.

2. The real risk is a duty gap in post-market obligations. MDS-REQ 11 V2.0 places the manufacturer, the AR and healthcare institutions in one reporting sequence: adverse events and complaints go to the NCMDR within 2 days for a serious public health threat, 10 days where death or serious injury may directly or indirectly result or be contributed to, and 30 days otherwise, with replies to NCMDR follow-ups within 5 days. In a transition, responsibility blurs easily: the old AR says the authorization has ended, the new AR says the system change is incomplete. GRZAN handles this via a contract handover date and retrospective period: events before handover are reported by the old AR with the manufacturer’s cooperation, events after it pass to the new AR, and the old AR hands over historical records and investigation files within a defined period. UDI-DI data in Saudi-DI is maintained by the manufacturer or the AR, so confirm database responsibility is synchronized after the change.

3. How the change is classified determines the fee and the process. Under the fee schedule (practical estimate): adding devices, adding models, brand name changes and minor changes of manufacturer name or address are each SAR 5,000; risk class changes and legal manufacturer name or address changes are charged at the full fee; label updates, IFU updates and advertising material updates are each SAR 1,100. Where an AR change falls depends on how GHAD currently classifies it; the billed amount prevails. Easily triggered in cascade is a simultaneous brand name or address adjustment: combining an AR change with packaging changes upgrades the change. Separate them: complete the AR change, confirm it took effect, then handle label-type changes, avoiding confusion of two changes in one application.

4. Cross-effects on the reliance pathway and Saudi-DI. A Reliance Form under the reliance pathway (MDS-G030 V1.0) must be signed and sealed by the authorized signatory, declaring the approvals submitted apply to all listed devices. After an AR change, the signatory and filing contacts change; confirm whether contacts and the authorization chain in existing records need updating (practical estimate, per GHAD). The MDMA certificate states its issue and expiry dates and grants a Marketing Authorization Number and a Medical Device National Listing Number, which should not change after an AR change. If the numbers change in the system, the change was treated as a new application; contact the SFDA immediately.

For entity eligibility and duty boundaries before an AR change, see https://www.grzan.cn/regulations/saudi/authorized-representative-licensing-and-duties-31 ; for UDI-DI data maintenance responsibility, see https://www.grzan.cn/regulations/saudi/udi-and-saudi-di-database-37 .

4. Practical recommendations

• Confirm the certificate holder first: retrieve the MDMA certificate, verify it is issued in the manufacturer’s name, and record the Marketing Authorization Number and Listing Number.
• Licence the new AR first: obtain an independent AR licence under MDS-REQ 9 (practical estimate SAR 2,600 per contract per year plus 15% VAT) before terminating the old authorization.
• Terminate the old authorization in writing: obtain a termination confirmation and agree the scope and deadlines for handing over historical adverse event files, investigation dossiers and Saudi-DI data.
• Ask the billing system about classification: before filing in GHAD, confirm the current classification and fee for an AR change to avoid the full fee.
• Separate the change from packaging work: file the AR change and label/IFU changes separately, avoiding cross-contamination between the SAR 5,000 and SAR 1,100 categories.
• Eliminate the duty gap: state the handover date, retrospective period and NCMDR reporting owner so the 2/10/30 day timelines always have an assigned owner.
• Synchronize contacts: update contacts and account permissions in GHAD, NCMDR and Saudi-DI together, keeping screenshots.
• Fall back on official channels: where the system display contradicts the certificate, use SFDA free support, call centre 19999 and md.rs@sfda.gov.sa.

5. Verification checklist

• □ MDMA certificate confirmed as issued in the manufacturer’s name, with number and listing number recorded
• □ The new AR holds an independent licence, with licence number and contract number archived
• □ The old AR’s termination letter obtained, handover scope and deadlines agreed in writing
• □ Authorized representative information for the MDMA updated in GHAD, screenshots retained
• □ Change fee classification confirmed with the GHAD billing system (practical estimate)
• □ Marketing Authorization Number and Listing Number unchanged
• □ Contacts and account permissions synchronized across NCMDR, Saudi-DI and GHAD
• □ Adverse event handover date and retrospective period written into the agreement
• □ Reliance Form authorized signatory reconfirmed where applicable
• □ Current version numbers of MDS-G011, MDS-REQ 1 and MDS-REQ 11 checked

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