MDMA Validity and Renewal: Certificate Dates, QMS Links and Fees

1. Key takeaways

There is no fixed number for MDMA validity that can be quoted directly into a budget table. Under the Implementing Regulation of the Medical Devices Law (SFDA Board Resolution No. (3-29-1443)), the MDMA must state its issue date and expiry date, and it simultaneously grants a Marketing Authorization Number and a Medical Device National Listing Number — so the only authoritative source of the validity is the dates printed on the certificate itself. Public third-party accounts diverge between 3 years and 5 years (practical estimate), and the MDMA validity is further constrained by the expiry of the supporting quality certificate — mainly the ISO 13485 certificate — so the actually granted term may be shorter than either of those caps. On renewal, the account consistent across multiple sources is that the application must be submitted at least 90 days before expiry (practical estimate); the renewal fee is generally 5,000 Saudi Riyal (SAR) plus 15% VAT (practical estimate, subject to the invoice issued by the GHAD billing system). Regulatory information verified as of 29 October 2026.

• The MDMA must state its issue and expiry dates; those printed dates are the only authoritative validity source.
• Third-party accounts of 3 years and 5 years diverge (practical estimate); the QMS certificate expiry can shorten the term.
• Renewal: submit at least 90 days before expiry (practical estimate).
• Renewal fee: generally 5,000 SAR plus 15% VAT (practical estimate), per the GHAD billing invoice.

2. Legal basis

The following instruments govern what the certificate must state, the QMS that supports it, and the third-party accounts on validity and renewal that still require verification against official output.

3. Expert insights

1. Why no unified validity can be cited

This is not the result of incomplete research; it is what the system design produces. The Implementing Regulation does not write the validity as a fixed number of years; it requires the MDMA to state its issue date and expiry date — the legislature placed the power to set the term at the issuance stage rather than fixing a uniform term at the legal level. The benefit is that the issuing authority can weigh the circumstances of the specific product at issuance; the cost is that companies cannot extrapolate uniformly across products. The 3-year and 5-year figures circulating in third-party articles very likely correspond to actual issuance outcomes of different periods, risk classes or quality-certificate states; applying them as universal rules will produce errors in budget ledgers. The operational approach is: do not extrapolate, register — record the printed issue and expiry dates of every MDMA in the ledger and back-plan the renewal from them. GRZAN manages its agency projects exactly this way: the ledger records only the dates as they appear on the certificate, never any extrapolated result.

2. The real time boundary is often on the quality certificate

The MDMA validity cannot exceed the expiry date of the supporting QMS certificate — a key link in understanding the Saudi certificate system. The QMS answers within what period the company’s quality commitment has been validated; since the MDMA is built on the QMS, once the QMS certificate expires the MDMA loses its support and its validity naturally cannot run longer. This rule produces a counter-intuitive result: a company may receive a 5-year MDMA, but if the supporting ISO 13485 certificate has only 2 years left, what can actually be used is 2 years. Two management actions follow: first, treat the ISO 13485 or MDSAP certificate expiry as a first-level alert date, rather than waiting until the MDMA nears expiry; second, leave enough lead time when scheduling quality-certificate renewal so the MDMA does not break first.

3. Renewal is not resubmission

What the renewal review really turns over is everything that happened during the past term. New models added, key suppliers changed, packaging materials modified, label language adjusted, production sites expanded — each of these carried a notification duty at the time it occurred (see the significant and non-significant change determination of MDS-G12). Where those changes were notified and approved through procedure, renewal is usually smooth; where changes actually happened but were never notified, renewal concentrates the exposure — at best deficiency fixes, at worst a demand for reassessment against the as-is state. Renewal preparation should therefore start on the day a change occurs, not 90 days before expiry: every change leaves a compliance record, and expiry is only the moment of aggregation. The fee account is in https://www.grzan.cn/regulations/saudi/sfda-mdma-fee-structure-sar-38 ; the change-determination framework is in https://www.grzan.cn/regulations/saudi/significant-and-non-significant-change-46 .

4. Practical recommendations

• Build a dual-date ledger: the MDMA issue and expiry dates and the QMS certificate expiry date — record both and set separate alerts.
• Set the alert line conservatively: complete the QMS certificate renewal before discussing the MDMA renewal.
• Start the renewal at least 90 days ahead (practical estimate); do not compress submission into the final week.
• For every product, process, label, site or system change, make the MDS-G12 judgement the same day and archive the conclusion for aggregation at renewal.
• If the product has gained a new RRA approval meanwhile, assess whether the next application can move to the MDS-G030 reliance pathway and write the pathway upgrade into the renewal plan.
• Prepare the fee budget as the 5,000 SAR renewal fee plus 15% VAT (practical estimate); the amount paid follows the GHAD billing invoice and payment goes through SADAD.
• Enter the Marketing Authorization Number and the Medical Device National Listing Number into the ledger; filings, labels and UDI data maintenance all follow them.
• If the company name, address or AR changes, first confirm whether the MDMA change procedure is triggered; do not leave it to renewal.

5. Verification checklist

• □ The printed issue and expiry dates of every MDMA certificate are recorded in the ledger
• □ The expiry dates of the supporting ISO 13485 / MDSAP certificates are recorded and set as a first-level alert
• □ The ledger does not hard-code 3 years or 5 years; it uniformly states that the certificate dates prevail
• □ The renewal is back-planned to start at least 90 days ahead (practical estimate)
• □ All changes during the certificate term have been determined under MDS-G12 with records kept
• □ It has been checked whether any supplier, process or label change went unnotified
• □ It has been assessed whether the next application can switch to the MDS-G030 reliance pathway
• □ The renewal budget includes 5,000 SAR plus 15% VAT (practical estimate), with SADAD as the payment channel
• □ The Marketing Authorization Number and Medical Device National Listing Number are entered and consistent with GHAD

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 MDMA applications across classes, prepares reference-approval dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzan.com