SFDA has issued Version 9.0 of the “Products Classification Guidance”, introducing updated principles, procedures, and sector-specific rules that define how products are classified across all SFDA-regulated categories.

🔍 What’s new:

• Updated classification principles covering food, drugs, medical devices, cosmetics, pesticides, feed, veterinary products, tobacco, raw materials, and mixed-category items.
• Enhanced procedural guidance for electronic submission through the SFDA classification platform, including documentation requirements, decision issuance, objection procedures, and reclassification pathways.
• Expanded clarification on borderline products, mixed products, innovative product classification, and raw-material regulatory routes.

💡 Why it matters:

Accurate product classification determines the applicable regulatory pathway, sector oversight, technical requirements, and post-market obligations. Misclassification may lead to delays, additional data requests, or rejection.

📋 Key points:

• Defined sector-specific classification rules and decision criteria.
• Clear electronic submission steps with required documentation.
• Formal objection process within 30 days of decision issuance.
• Dedicated pathway for innovative products and reclassification requests.

📌 How ReguLinked can support you:

• Evaluating product positioning to confirm the appropriate SFDA regulatory sector.
• Preparing and submitting structured classification applications through the SFDA platform.
• Supporting objection filings and reclassification strategies.
• Ensuring documentation completeness and regulatory readiness prior to submission.

Need to classify new products or reclassify existing products?
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📧 bd@regulinked.com | 🌐 www.regulinked.com

📎 Official Guideline: Products Classification Guidance V9

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