GRZAN Saudi Compliance Calendar and Action List 2026-2027

1. Key takeaways

The obligations covered across these ten articles can be compressed into one executable calendar. Every quarter, run one classification and Saudi-DI review; every six months, one review of the bundling scheme and change judgements; every year, complete the PSUR or PMS report, the system-versus-product cross audit and MDMA renewal scheduling; event-driven actions trigger on the 2-day, 10-day and 30-day reporting tiers and the 15-day, 30-day and 60-day investigation tiers. The three 2026 instruments each have fixed anchors: MDS-G030 can be used for application planning from 2026-09-09 with review in 35-60 working days; MDS-G028 applies as the bundling criterion from 2026-05-03; e-GHAD classification decisions carry a validity of 1 year and an appeal period of 30 days (a practical estimate, subject to current SFDA announcements). GRZAN has organised this rhythm into the table below for Chinese manufacturers to schedule directly into internal plans.

• Quarterly: classification review and Saudi-DI reconciliation.
• Semi-annually: bundling scheme and change judgement review.
• Annually: PSUR or PMS report, cross audit, MDMA renewal scheduling.
• Event-driven: the 2/10/30-day reporting tiers and 15/30/60-day investigation tiers.
• The 2026-2027 calendar spreads classification re-reviews across quarters to level the load.

2. Legal basis

The calendar draws together the deadlines and cycles established across the series; the statutory items carry official numbers, while the renewal lead time and the PSUR cycles are a practical estimate pending verification on the SFDA platforms.

3. Expert insights

1. The value of a calendar is turning passive obligations into active scheduling. Most failures in post-market compliance come not from not knowing the rules but from not scheduling them. The three reporting tiers are event-driven and cannot be scheduled in advance; but classification reviews, Saudi-DI reconciliations, PSURs, MDMA renewals and system audits can all be scheduled. Once the schedulable items are scheduled, the team has capacity left for the event-driven ones. GRZAN recommends merging Saudi obligations into the global compliance calendar rather than maintaining a separate table, because a standalone table is the first thing to lose ownership when personnel change.

2. The three new instruments have different time anchors and cannot run on one rhythm. MDS-G028 is a pre-application decision rule, applying immediately to every new application and change; MDS-G030 is a route selection rule, used once at product initiation and submission strategy stage, but re-checked as RRA approval status changes; e-GHAD classification decisions are a periodic state, re-scheduled against the validity period. Mixing the three into one monthly checklist produces rhythm errors: treating MDS-G028 as an annual item misses immediate judgements, and treating classification as a one-off event means running past the validity period.

3. The main variable for 2027 is the first overlap of classification re-reviews and periodic documents. On the current calibre, classification decisions applicable from 2025-11-20 expire in sequence after their 1-year validity (a practical estimate), so the second half of 2026 through 2027 is the first concentrated re-review window; in the same period the annual PSURs of Class C and D devices and routine MDMA renewals also stack up. If all three categories of actions land in the same quarter, the load on the AR and the internal registration team rises sharply. Spreading the classification re-reviews across different quarters within 2026 is the cheapest way to level the peak.

4. Practical recommendations

Q4 2026 (October-December)

• Download and archive the current texts of MDS-G030 V1.0 (2026-09-09) and MDS-G028 V1.0 (2026-05-03) and establish the internal reference versions.
• Verify on e-GHAD the validity of classification decisions for all licensed and pending products, and spread the expiry dates across 2027 quarters (the related dates are a practical estimate).
• Complete one GHAD and Saudi-DI data reconciliation, focusing on model names and GMDN codes.
• Re-plan product family schemes against MDS-G028 and identify applications needing additional technical files or component list letters.

Q1 2027

• Complete the reliance eligibility self-assessment: check the 6 RRA approvals, technical sameness and the Saudi-specific requirements item by item (including Part 401 of the Saudi Building Code, label language, and storage and transport requirements).
• Re-plan the market timetable on 35-60 working days, putting the Reliance Form and RRA approval evidence into the submission pack.
• Build or review the PMS ticketing system so the three investigation tiers generate deadlines automatically.

Q2 2027

• Execute the annual system-versus-product cross audit and update the inspection response pack.
• Complete the PSUR for Class C and D devices and the PMS report for Class A (the cycle is a practical estimate, subject to current SFDA documents).

Q3 2027

• Start MDMA renewal for licences at least 90 days before expiry (a practical estimate, follow the GHAD portal prompts), and review in parallel how ISO 13485 certificate validity constrains the MDMA term.
• Review the exclusion status and alternative strategies of the SaMD and AIeMD product lines under the reliance pathway.

All-year event-driven actions

• Whenever any RRA jurisdiction triggers a recall or FSCA, start the Saudi-side assessment within 24 hours and report under the three-tier deadlines.

5. Verification checklist

• □ Current texts of MDS-G030 and MDS-G028 have been archived
• □ The e-GHAD classification decision validity list has been established (a practical estimate)
• □ The quarterly GHAD and Saudi-DI reconciliation mechanism is running
• □ Product family schemes have been re-planned under MDS-G028
• □ The reliance eligibility self-assessment has been completed
• □ The Reliance Form and RRA approval evidence are ready
• □ The PMS ticketing system can generate the three investigation-tier deadlines
• □ The annual system and product audit has been executed
• □ PSUR and PMS report cycles have been verified on the portal (a practical estimate)
• □ MDMA renewal scheduling carries a 90-day lead time (a practical estimate)
• □ The global recall ledger is bound to the Saudi notification action

Regulatory information verified as of October 29, 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 adverse event reporting and recall coordination with the SFDA National Center, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com