Resolution No. (48) of 2020

Resolution No. (48) of 2020, issued by the Chairman of the Supreme Council of Health, is the instrument that puts medical devices and products under quality control in Bahrain. Eighteen articles: the definition set (Article 1, including the device definition and the persons it binds), the objective and the scope over all health facilities that use devices, the Authority's monitoring and market-surveillance powers (Articles 4 and 11–12), the electronic registration system (Article 5), the obligations of importers, distributors, manufacturers and authorized representatives (Article 6), the licensing and permit requirements for facilities (Articles 7–8), storage and transport duties (Article 9), the prohibition on marketing or advertising an unregistered device (Article 10), disposal (Article 13), delegation to the Conformity Assessment Department (Article 14), the penalty clause (Article 15), the Chief Executive Officer's power to issue the requirements, controls and procedures that carry it into practice (Article 16), fee categories (Article 17) and the implementation clause (Article 18). The Arabic original is dated 14 Jumada I 1442 / 29 December 2020, was published in Official Gazette No. 3504 of 31 December 2020 (pp. 39–45) and entered into force the day after publication; the NHRA English translation prints 28 December 2020 as its issue date. Each NHRA guideline row on this page is issued under a stated article of this resolution and quotes it: Article (5) for registration, Article (6) for authorized representatives, Article (7) for importation, Article (11) for field safety notices and Article (16) for reporting. The PDF is the English text only; the Arabic original is not part of this file, so no Arabic source file is recorded against this row.

Resolution No. (48) of 2020 is the official identifier NHRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.