KUWAIT — The Ministry of Health’s Medicines & Medical Products Registration & Regulatory Administration has released the Ministerial Decree 344/2025, establishing a rigorous new framework for the registration, importation, and marketing of cosmetic products.
This comprehensive 22-page guidance aligns Kuwait’s regulatory standards with EU Cosmetic Regulation (EC) No 1223/2009 and GSO Standards, introducing stricter controls on product claims, ingredients, and labeling. For medical device manufacturers with “companion” skincare or aesthetic portfolios, the Decree introduces critical “borderline” product reclassification risks that may impact market access strategies.
EU COSMETIC REGULATION (EC) NO 1223/2009 : KEY HIGHLIGHTS OF DECREE 344/2025
The Decree outlines mandatory requirements for manufacturers, local agents, and Marketing Authorization Holders (MAH) intended to ensure product safety and prevent misleading therapeutic claims.
- Strict “Medical Claim” Prohibition: The Decree explicitly defines “Unacceptable Claims” as any statement implying a product treats a medical condition or alters physiological functions. Products making such claims will likely be rejected as cosmetics and may require registration as pharmaceutical or medical products.
- “Medicated Features” Verification: Products that possess “medicated features” (often found in post-procedure dermatology lines) are now subject to higher scrutiny. Applicants must submit efficacy and safety studies to substantiate these specific features.
- Reclassification Authority: The Ministry reserves the right to reclassify existing registered products based on their claims or ingredient concentrations. If a product is deemed “medical” during an audit, it may be forced into a transition period to re-register under the correct department.
- EU-Aligned Ingredient Bans: Kuwait has harmonized its “Prohibited and Restricted Substances” list with Annexes II & III of the EU Cosmetic Regulation. This includes a strict ban on Carcinogenic, Mutagenic, and Reprotoxic (CMR) substances.
- Mandatory Bilingual Labeling: All product labels must now include key information (warnings, instructions, ingredients) in Arabic and/or English. Specific warnings are mandatory for tanning products without SPF, and nano-materials must be explicitly labeled with the suffix.
IMPACT ON MEDICAL DEVICE & AESTHETICS MANUFACTURERS
While this Decree targets “Cosmetics,” its implications for the MedTech sector specifically Aesthetics, Dermatology, and Wound Care are significant.
- Portfolio Risk: Manufacturers selling topical creams, gels, or serums alongside devices (e.g., laser cooling gels, post-peel neutralizers) face a high risk of reclassification if their marketing materials use therapeutic language like “healing,” “treatment,” or “cure.”
- Clinical Evidence Burden: The requirement for efficacy studies for “medicated features” shifts the burden of proof. Manufacturers can no longer rely solely on ingredient safety data; they must demonstrate that the “medicated” aspect works as claimed without crossing the line into drug territory.
- Labeling Overhaul: Global SKUs may need specific Kuwait-compliant over-labeling to meet the bilingual and specific warning requirements, particularly regarding the declaration of nanomaterials and allergens.
RECOMMENDED ACTIONS FOR MANUFACTURERS
To ensure continued market access and compliance with MD 344/2025, companies are advised to:
- Conduct a Claims Audit: Review all marketing materials and packaging for “borderline” products to remove medical terminology prohibited under the new “Unacceptable Claims” definition.
- Verify Ingredient Lists: Cross-reference all formulations against the latest EU Annex II & III lists to ensure no prohibited preservatives or CMR substances are present.
- Prepare Clinical Data: For products with “medicated” claims, organize existing clinical evaluation reports (CERs) or safety studies to meet the new submission requirements.
- Monitor Reclassification: Stay in close contact with your Authorized Representative in Kuwait for notifications regarding product reclassification to utilize the provided grace periods effectively.
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