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Saudi Arabia Medical Device Registration

Saudi Food and Drug Authority (SFDA) approval timelines and requirements

1-2 weeks
Typical Timeline
4
Device Classes
No
MDSAP Accepted
Required
Saudi Authorized Representative

Saudi Arabia Medical Device Registration Overview

Saudi Arabia medical device registration through SFDA typically takes 1-2 weeks for Class A devices. The official SFDA target is 1 week, but realistic timelines include preparation, documentation review, and potential questions from regulators.Saudi Arabia uses a 4-class (A, B, C, D) risk-based classification system. Foreign manufacturers must appoint a Saudi Authorized Representative to register devices in Saudi Arabia. Registration is valid for 5 years.

Registration Timeline by Device Class

Saudi Arabia uses a 4-class (A, B, C, D) risk-based classification system.

Class A

MDNR Listing

Low Risk
Official
1 week
Realistic
1-2 weeks

• Fastest pathway

Class B

MDMA Registration

Medium Risk
Official
1-2 months
Realistic
1.5-3 months

• Full technical file required since Jan 2022

GMP/QMS Required

Class C

MDMA Registration

High Risk
Official
2-4 months
Realistic
3-5 months

• Clinical data may be required

GMP/QMS Required

Class D

MDMA Registration

Highest Risk
Official
3-5 months
Realistic
4-6 months

• Extensive clinical data required

Clinical Trial RequiredGMP/QMS Required
Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Saudi Arabia registration.

FDA 510(k)
GHTF route canceled Jan 2022 - data helps but no expedited path
None
EU CE Mark
GHTF route canceled Jan 2022
None
Key Requirements
  • Saudi Authorized Representative
  • Complete Technical File (since Jan 2022)
  • Arabic labeling
  • ISO 13485 certification
Registration Validity:

5 years

Registration Process Flowchart

Saudi Arabia Medical Device Registration Process

Step-by-step SFDA registration process. Total estimated timeline: 1-2 weeks.

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

1 week

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.
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Related Resources
SFDA Regulation NewsGovernment Registration Fees
Compare With
🇺🇸 United StatesFDA🇪🇺 European UnionEU MDR🇨🇳 ChinaNMPA🇯🇵 JapanPMDA🇧🇷 BrazilANVISA🇨🇦 CanadaHealth Canada
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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.