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MDS-REQ 8 & Saudi-DI UDI
Labeling, IFU, UDI & Advertising Compliance (SFDA)
The Saudi-Market Product Must Match the Authorized Regulatory Position. Labeling and Instructions for Use should remain consistent with the intended purpose, technical file, risk controls and marketing authorization. Saudi requirements may also affect language presentation, manufacturer and AR information, symbols, UDI and promotional claims.
When This Support Is Needed
Preparing Arabic and English product labels, packaging artwork, and IFUs for Saudi market launch
Implementing physical and digital Unique Device Identification (Saudi-DI UDI) on product packaging
Reviewing marketing, commercial advertising, or promotional campaign materials under MDS-REQ 8
Updating manufacturer, legal Authorized Representative, or regulatory contact details on labeling
What We Challenge Before Submission
Does the device require mandatory Arabic instructions for use based on its intended user (lay person vs professional)?
Are the Authorized Representative's legal name, establishment license number, and Saudi address displayed accurately?
Do Saudi-DI UDI records in the SFDA portal match the physical packaging hierarchy (unit of use, box, carton)?
Do promotional marketing claims in Arabic strictly reflect the clinical intended use authorized in the MDMA?
Are temperature, humidity, sterility, and expiration symbols completely aligned with study validation reports?
Our Labeling & Advertising Scope
Product label and Instructions for Use (IFU) regulatory compliance review against SFDA standards
Bilingual Arabic and English language alignment for professional and lay-user medical devices
Legal manufacturer and Saudi Authorized Representative identification on primary/secondary packaging
Warnings, contraindications, precautions, and residual risk statement harmonization
Standardized symbol verification (ISO 15223-1) and localized storage/sterility condition labeling
Saudi-DI UDI code assignment, barcode verification (GS1 / HIBCC), and electronic database submission
IVD-specific labeling, reagent storage, specimen handling, and performance claim review
Electronic Instructions for Use (e-IFU) eligibility assessment and secure hosting compliance
Medical device advertising, commercial brochure, and promotional campaign review under MDS-REQ 8
Regulatory impact assessment for post-approval packaging revisions and artwork changes
Consistency Rule:
We compare the label against the MDMA record, technical file and underlying evidence. A labeling change can become a regulatory change if it alters intended purpose, indication, performance claims or risk profile.
Ensure Bilingual Arabic Labeling and Saudi-DI UDI Compliance
Our regulatory team audits packaging artwork, translates clinical IFUs into Arabic, and manages Saudi-DI electronic submissions.