Saudi Arabia medical device registration timeline

Source-linked clocks

Saudi Food and Drug Authority (SFDA) review clocks and end-to-end planning ranges, using the 4-class (A, B, C, D) classification system.

4 pathways4 of 4 clocks verifiedvalidity 3 years for Class A non-sterile non-measuring devices; for all other classes the MDMA runs to the remaining validity of the underlying reference-market certificate, or 3 years where that certificate has no defined validityMDSAP not acceptedreviewed 2026-08-30sfda.gov.sa

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class A(MDMA Registration (Technical File Assessment)) SFDA publishes one lead time for every fee group in its MDMA evaluation fees table: 35 working days, from the lowest group (all Class I and general IVDs) to the highest. The FAQ repeats the same 35-business-day maximum without distinguishing risk class There is no separate low-risk listing route any more. The Medical Device National Registry, which let non-sterile non-measuring Class A devices be listed without a technical file or an Authorized Representative, was cancelled in September 2022 What Class A still gets is a lighter dossier, not a lighter process: MDS-REQ 1 item 4 cuts the submission for low-risk devices that are not IVDs, sterile, measuring, reusable surgical instruments or novel down to six elements — device description and specification, information provided by the manufacturer, essential principles checklist, evidence of compliance, risk management file, and post-market surveillance plan and report The abbreviated dossier is conditional: SFDA may demand the full technical documentation at any point, including after the MDMA has been granted, and it must be supplied within 10 days	35 working days	1.5-3 months	—	Verified
Class B(MDMA Registration) SFDA FAQ: the marketing authorization (MDMA) is issued within 35 business days as a maximum if all requirements are fulfilled Full technical file required since Jan 2022	35 working days	1.5-3 months	—	Verified
Class C(MDMA Registration) SFDA FAQ: the marketing authorization (MDMA) is issued within 35 business days as a maximum if all requirements are fulfilled Clinical data may be required	35 working days	3-5 months	—	Verified
Class D(MDMA Registration) SFDA FAQ: the marketing authorization (MDMA) is issued within 35 business days as a maximum if all requirements are fulfilled Extensive clinical data required	35 working days	4-6 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Saudi Arabia Medical Device Registration Process

Step-by-step SFDA registration process. Total estimated timeline: 1.5-3 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by SFDA. Appoint a Saudi Authorized Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to SFDA including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

SFDA reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

35 working days

In-depth technical assessment of device safety and performance. SFDA may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, SFDA issues Saudi Arabia market authorization certificate.

Summary: The Saudi Arabia medical device registration process through Saudi Food and Drug Authority (SFDA) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

FDA 510(k)GHTF route canceled Jan 2022 - data helps but no expedited pathNone

EU CE MarkGHTF route canceled Jan 2022None

Key requirements

Saudi Authorized Representative
Complete Technical File (since Jan 2022)
Arabic labeling
ISO 13485 certification
One route for everything: MDMA-2, the Technical File Assessment, has been the only live pathway since January 2022, after the GHTF reliance route closed at the end of 2021 and the low-risk national registry closed in September 2022
Filed through the GHAD unified electronic system by a licensed local manufacturer or by the Authorized Representative, who must hold their own GHAD licence before the MDMA application can be lodged (MDS-REQ 1 item 4)
Clinical trial approval granted no later than 60 days when requirements are met (MDS-ExcE Art. 7.5(1))
Advertising review: 1st Track (within the MDMA application) 35 days; 2nd Track (separate) 10 days; missing documents must be provided within 90 days of the incompleteness notification or the application is VOID
Post-approval reporting clocks: significant changes must reach SFDA through the electronic system within 10 days, non-significant changes within 30 days (MDS-REQ 1 item 5)
Renewal is filed before expiry and the request can be submitted from 90 days before the expiry date (MDS-REQ 1 item 6)

Primary regulator sources

sfda.gov.sa · SFDA FAQ — MDMA issued within 35 business days sfda.gov.sa · SFDA MDMA evaluation fees table — 35 working day lead time for every fee group, MDMA validity 3 years sfda.gov.sa · SFDA MDS-REQ 1 V6 — Requirements for Medical Devices Marketing Authorization sfda.gov.sa · SFDA MDS-ExcE — clinical trial approval no later than 60 days (Art. 7.5(1))

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against SFDA publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:saudi-arabia:class-a