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NHRA MDR

MDR Guideline — Medical Device Registration, Ver 9.1

Medical Devices Registration Guideline, Version 9.1
BahrainNational Health Regulatory Authority (NHRA)Registration
What this code is

MDR Guideline — Medical Device Registration, Ver 9.1 is the official NHRA identifier for “Medical Devices Registration Guideline, Version 9.1”. MDR Guideline — Medical Device Registration, Ver 9.1 is the official identifier NHRA uses for this instrument.

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MDR
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MDR Guideline — Medical Device Registration, Ver 9.1
Category
Registration
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About this regulation

Medical Devices Registration Guideline, Version 9.1

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.

MDR Guideline — Medical Device Registration, Ver 9.1 is the official identifier NHRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.