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Libya medical device regulations

Official sources linked

Ministry of Health rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.

3 documents3 categories100% linked to official sourcesauthority Ministry of Health3 readable HTML
CodeRegulationCategoryEffectiveProvenance
قانون رقم 106 لسنة 1973
القانون الصحي
Complete forty-page Arabic publication of the 1973 Health Code, preserved by FAOLEX. It provides the general statutory context for therapeutic institutions, pharmaceutical establishments, medical professions and medical apparatus; this is a historical framework source, not an asserted current device-specific registration regulation. OCR replaces a corrupted embedded Arabic text layer. Later amendments and device-specific implementing requirements remain to be verified.
General—Official
قرار وزير الاقتصاد والتجارة رقم 379 لسنة 2023
بشأن تطبيق معايير (تجي إس 1 – GS1) ووضع مصفوفة البيانات (باركود ثنائي الأبعاد) على المنتجات الدوائية والمعدات الطبية بالسوق الليبي
Complete signed and stamped four-page Arabic Decision 379/2023 of the GNU Minister of Economy and Trade, visibly dated 23 July 2023 (5 Muharram 1445), with full preamble, Articles 1–8 and both barcode examples. It applies GS1/DataMatrix identification to pharmaceuticals and medical equipment in Libya. Article 5 specifies GTIN, batch and a unique random serial per equipment item; Article 4 separately specifies pharmaceutical expiry information, which is not added to the equipment article. Article 6 states a six-month implementation deadline from issue and later circulation prohibition for products/equipment without the prescribed barcode. The literal drafting of Article 3 and illustrative digit strings are retained rather than repaired. This Economy and Trade instrument is not issued by the 2025 GAMESD authority. Implementation extensions, exemptions, amendments and applicability in 2026 remain unverified.
UDI—Official
قرار وزير الاقتصاد والتجارة رقم 692 لسنة 2023
بشأن حظر استيراد سلعة
Complete signed and stamped one-page Arabic Decision 692/2023 of the GNU Minister of Economy and Trade, visibly dated 14 November 2023 (30 Rabi al-Thani 1445). Article 1 prohibits import of used medical devices/equipment of all forms, types and classifications, including their spare parts. The signed article contains no Ministry of Health exception; the extra exception wording in the official trade-directory summary is excluded from the source text. Article 2 assigns follow-up to the Ministry of Health with the technical/security committee under Decision 1211/2023 and enforcement/re-export to Customs and competent authorities. Article 3 requires execution and repeals contrary provisions. This issuer is not GAMESD. Later amendments, committee materials and applicability in 2026 remain unverified.
Registration—Official
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Tracked from official Ministry of Health publications · row IDs are stable — cite as regulations:libya:health-law-106-1973