GHAD Electronic Portal: SFDA E-Services Submission System

1. Key takeaways

GHAD is the unified electronic submission system of SFDA for medical devices. MDMA applications, AR accounts and technical file uploads all run through it, with no parallel paper or email channel. Third-party accounts say SFDA launched the unified GHAD electronic system in December 2019, replacing the two former gateways of MDNR (low risk) and MDMA (medium and high risk), and after several extensions fully replaced the legacy system on 27 September 2022 (these dates are not corroborated by the original SFDA website text and are treated as a practical estimate). MDS-G030 V1.0 expresses it in the application steps as the SFDA E-Services portal, so the prudent formulation is the SFDA electronic services platform (GHAD / E-Services). Its institutional meaning has three layers: single gateway, checkpoint of data consistency, and the vehicle through which SFDA maintains continuous supervision of companies and products.

• GHAD is the single electronic gateway; MDMA applications, AR accounts and technical file uploads all run through it.
• GHAD launched in December 2019 and fully replaced the legacy MDNR and MDMA gateways on 27 September 2022 (practical estimate).
• MDS-G030 V1.0 Step 1 requires an SFDA E-Services portal account and an Establishment Number.
• In the reliance pathway, Section (2.1) of the Overview part must be answered Yes to activate Section (2.1.1), and the uploaded Annex (1) file must be named Reliance Form with the country set to Saudi Arabia.
• Model names and GMDN codes must be accurate and identical in both GHAD and Saudi-DI (MDS-REQ 7 V4.0).

2. Legal basis

The table lists the documents and systems behind the GHAD submission flow, including the reliance pathway steps.

3. Expert insights

A single gateway means data inconsistency will always surface

After the MDNR and MDMA gateways merged, the risk class, classification decision, model name, GMDN code and UDI-DI data of the same device all sit in one data foundation. MDS-REQ 7 V4.0 requires the manufacturer or the AR to submit and maintain the data in Saudi-DI, with the data in GHAD and Saudi-DI — model names, GMDN codes — accurate, and new UDI-DI data in the database when the device is placed on the market. A model name differing by a single space between the registration team and the UDI owner can be caught in the comparison at customs clearance or market sampling. Compared with EUDAMED, whose modules went live on a scattered timetable and some of which are not yet fully mandatory, and the US GUDID, where data submission and 510(k) review are also two systems, Saudi Arabia binds registration and the database much more tightly. The benefit is high regulatory efficiency; the cost is that companies must internally integrate three data sources — registration, UDI and labelling.

The submission details of MDS-G030: two hard gates hidden in three steps

The reliance pathway application steps are written concretely, and two spots are easiest to get wrong. The first is the Establishment Number at Step 1: if the company has not opened an account on the SFDA E-Services portal, none of the subsequent actions can start — which is why GRZAN recommends running this in parallel with AR screening. The second is the linkage of Step 2 and Step 3: the question at Section (2.1) of the Overview part of the MDMA application must be answered Yes before Section (2.1.1) is activated; Country and Title are then completed item by item and each approved Evidence Document uploaded. The Step 3 file, the Reliance Form of Annex (1), must be named exactly Reliance Form, with the country of applicability set to Saudi Arabia. Such hard conventions on field and file names show GHAD runs automated validation no human explanation can bypass. Once through, the standard review timeline is 35 to 60 working days, identical across the four risk classes.

Comparison with China’s NMPA, the EU and the US systems: open the account once, maintain it long term

China’s NMPA electronic submission (eRPS) mainly serves registration filings, with separate systems for production licensing and adverse events; the EU’s EUDAMED covers economic operator registration, UDI, certificates and vigilance in several modules; the US FDA separates FURLS/Device Facility from GUDID. Saudi GHAD concentrates these functions further, with the AR account, entity qualification, technical files and product authorisation sharing one account system. GHAD account permission management must therefore be treated as a compliance asset: who holds submission and edit rights, and how leavers’ access is revoked, need written rules. One mistaken submission creates an official record immediately, and withdrawal and correction cost far more than prior control. GRZAN recommends a three-way verbatim comparison before submission, aligning the product model in GHAD, the UDI-DI in Saudi-DI and the physical label. This benefits EU and US projects too, but in Saudi Arabia it is a hard requirement: the registration system and the device database share the same keys, and once the model diverges, every subsequent change amplifies the mismatch. In addition, SFDA provides manufacturers free technical support (call centre 19999, mailbox md.rs@sfda.gov.sa, meetings with the SFDA technical team and workshops); system-level rule questions can be put directly to the authority, keeping the reply on file.

Account opening and its AR link are discussed at https://www.grzan.cn/regulations/saudi/sfda-authorized-representative-mandatory-05 , and the reliance pathway submission details at https://www.grzan.cn/regulations/saudi/sfda-reliance-pathway-mds-g030-12 .

4. Practical recommendations

• Open the SFDA E-Services portal account in parallel with AR screening and obtain the Establishment Number early.
• Establish a GHAD account permission management system: name the holders of submission, edit and approval rights, revoking access immediately on departure or change.
• Integrate registration, UDI and labelling data sources; keep model names and GMDN codes identical in all three, and confirm new UDI-DI data is in the database before market placement.
• Follow Step 2 strictly: answer Yes at Overview Section (2.1) to activate Section (2.1.1), then complete Country and Title item by item and upload the Evidence Documents.
• When uploading the Annex (1) Reliance Form, name the file exactly Reliance Form and set the country of applicability to Saudi Arabia, checking both verbatim before submission.
• Schedule the review cycle at 35 to 60 working days, with the same figure for Classes A, B, C and D.
• For system-level rule questions, use the free SFDA support channels (call centre 19999, mailbox md.rs@sfda.gov.sa) for official confirmation, retaining the replies.
• Cite the GHAD launch and switch-over dates as a practical estimate; formally defer to current SFDA announcements and portal notices.

5. Verification checklist

• □ SFDA E-Services account created and Establishment Number obtained
• □ GHAD account permission list established, covering submission, edit and approval rights and revocation
• □ Model names and GMDN codes identical across GHAD, Saudi-DI and label
• □ New UDI-DI data retrievable in Saudi-DI before market placement
• □ Reliance application confirmed with Overview Section (2.1) answered Yes and Section (2.1.1) activated
• □ Reliance Form file name and country field checked verbatim
• □ Review cycle scheduled at 35 to 60 working days
• □ Replies from official technical support channels retained
• □ GHAD-related dates flagged as a practical estimate, listed for re-checking

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