Bahrain medical device regulations

Medical Device Authorized Representative Registration Guideline, Version 7.4 (June 2023) — how a foreign manufacturer's authorized representative is registered and what the role carries. Nine numbered sections: the introduction, the general rules, the submission of registration, the requirements, the inspection process and its elements, certificate renewal and variation, the registered authorized representative classification, the commercial registration certificate and the annex. This is the row a foreign manufacturer needs, because the authorized representative is the legal person through whom the Bahraini registration is held. The document states no publication date of its own.

Circular No. (1) of 2022 — the cases that will not be included in the regulation of medical devices in Bahrain. It is a short instrument that states the exclusions: a single continuous passage listing the product situations the NHRA does not take into the device regime, which is why its extract is one body block rather than a set of articles. The circular is printed in Arabic and English side by side on the same official PDF. It is one instrument, so it has one regulation id; the Arabic and the English are recorded as two source files under that id, and both language versions are readable from the same page.

Circular No. (18) of 2022, from the Chief Executive Office of the NHRA — the assignment of a post-market surveillance officer. It tells the holders of Bahraini registrations who the officer is and what the role carries in post-market surveillance, and it opens by quoting Article (4) of Resolution (48) of 2020 — the Authority monitors the use of medical devices and products in the Kingdom and takes the measures needed to ensure their safe use and maintenance — as its basis, which is why the officer is placed with the facilities rather than with the Authority. Like Circular (1), it is printed in Arabic and English on one official PDF: one instrument, one regulation id, two source files. The English and Arabic passages are both short and each is carried as a single body block.

Medical Device Classification Guideline, Version 2.4, dated 29 June 2022 — how a device's risk class is determined in Bahrain. Eight numbered sections: the introduction, the important rules, the submission for classification, the requirements of classification, classification based on level of risk, the classification rules based on product technical details, the glossary and the annex. Read against the registration guideline, this is the guideline that fixes which of the four classes an application falls into. The document's own body numbering is off by one against its table of contents: the body prints 1, 2, 2, 3, 4, 5, 6, 7 for its eight sections — a repeated "2" and no "3" — while the contents page lists eight consecutive numbers. The extract follows the body, so the block ids run sec-1 … sec-8 in body order and the duplicated number is visible in the text rather than corrected.

Medical Devices Field Safety Notice Guideline — the rules for field safety notices (FSNs) and field safety corrective actions (FSCAs) for devices on the Bahraini market. Nine numbered sections: the definitions, the introduction, the general rules, the classification of a field safety notice, the process, the sources of field safety notices, the membership, the roles and responsibilities and the annex, and it opens by quoting Article (11) of Resolution (48) of 2020 — the Authority's power to review and check the communications its Medical Devices and Products section receives, and to take the measures a notice requires — as its basis. The version this row records is the one the document itself states on its cover: Version 2.1, January 2021, Ref. 2021-MDGUD-Q1-009. The registry lead for this file was titled "Version 3.0"; the file that URL actually serves is 2.1, and that is the version recorded here and printed in the summary, because the version a reader will find in the document is the version the row has to match.

Medical Device Importation Guideline (OFOQ), Version 11.1 (July 2024) — the import route for devices into Bahrain, run through the OFOQ single-window system. Ten numbered sections: the definitions, the introduction, the general rules, the requirements, the process of an OFOQ application, fee calculation and payment, product classification, samples, violations and the glossary. The section on fees is the one that connects this guideline to Resolution (24) of 2021, which is where the fee categories themselves are set. The document states no publication date of its own.

Medical Devices Labeling Guideline, Version 1.0 (January 2020) — the labelling standard for devices placed on the Bahraini market. Four numbered sections: the introduction, the definitions, the labeling standard and the label requirements. It is the shortest of the NHRA guidelines, and its title uses the American spelling "Labeling", which is the spelling the document and its source URL both carry; the row keeps it. The document states no publication date of its own.

The Medical Devices Registration Guideline, Version 9.1 (September 2024) — the operational statement of how a device is registered in Bahrain, and the longest of the NHRA guidelines. Fourteen numbered sections: the introduction, the general rules, the submission process, listing, the requirements of registration, software registration, research-use-only devices, appeal, licence variation, licence renewal, transfer of the local representative, manufacturer acquisition, the registration cancellation reasons and the bundling process. It is the guideline an applicant works through step by step. The document states no publication date of its own; the version number and the month are printed on the cover.

Medical Devices Reporting Guideline, Version 1.1 (January 2021) — the adverse-event reporting rules for devices on the Bahraini market. Nine numbered sections: the introduction, the definitions, the adverse event reporting types, the NHRA process, the roles and responsibilities, the reporting time frame, complaints, the reporting requirements during a pandemic and the annex. The time-frame and pandemic sections are what an applicant cannot infer from the statute, and the guideline opens by quoting Article (16) of Resolution (48) of 2020 — the clause that lets the Chief Executive Officer issue the requirements, controls and procedures the resolution is carried out by — as its basis. The document states no publication date of its own.

Resolution No. (24) for 2021, published in the National Gazette No. 3513 of 4 March 2021, issued by the Minister of Health. Two articles: Article 1 adds Table (3) — the schedule of services and requests for medical devices and products in the National Health Regulatory Authority — to the tables annexed to Resolution (20) for 2016 on fee categories for private health facilities, and Article 2 is the implementation clause. The annexed schedule is carried in four tables: authorized-representative licensing services, device registration services, importation services and other services, each listing the service, the item, the type of fee and the amount as the PDF lays them out. This is the instrument behind every fee a device applicant pays, and it is the instrument the importation guideline points at when it explains fee calculation. The resolution is issued by the Minister of Health, not by the NHRA, which is why this row carries a different agency from the rest of the Bahraini set.

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. (69) of 2024, published in the Official Gazette, Issue No. 3781 of Thursday 21 November 2024, and issued by the President of the Supreme Council of Health. Six articles amend Resolution No. (48) of 2020 in place: Article One replaces the definition of "Facility" and Articles (3), (6), (7) and (9) and the first two paragraphs of Article (10); Article Two adds a definition to Article (1); Article Three inserts a new Article (7) bis; Article Four appends a phrase to Article (12); Article Five revokes the definitions of "Importer" and "Distributor" in Article (1); Article Six is the implementation clause. This is the amendment that Article (48)'s definitions must now be read through, so the two rows should be cited together. The resolution prints its own articles as "Article One" … "Article Six" in words rather than numerals, which is why the block ids on this extract are art-1 … art-6 with the source's own wording kept in each heading.

قرار رقم (85) لسنة 2023, issued by the Ministry of Industry and Commerce, which adopts the Gulf standard specifications for the health sector issued by the Gulf Standardization Organization (GSO) and recognises them as national standard specifications. Three articles: Article One adopts the annexed list of standards, Article Two repeals anything inconsistent with the resolution, and Article Three is the implementation clause addressed to the undersecretary and those concerned. It matters to a device applicant because it is the route by which a Gulf standard becomes a Bahraini one. Two things about this file should be known before the text is read. First, only pages 1–2 — the resolution's own articles — carry a text layer; pages 3–11, the annexed list of adopted standards that Article One makes operative, have none, so the list of which standards were adopted cannot be read out of this file. Second, the text layer that does exist is degraded: the pages contain unmapped-glyph replacement characters in a number of words (for example in وزارة الصناعة والتجارة and in مرسوم). The extract holds exactly what the file contains, replacement characters included; nothing was repaired or reconstructed.