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MDR Guideline — Medical Devices Field Safety Notice, Ver 2.1

Medical Devices Field Safety Notice Guideline, Version 2.1
BahrainNational Health Regulatory Authority (NHRA)Vigilance
What this code is

MDR Guideline — Medical Devices Field Safety Notice, Ver 2.1 is the official NHRA identifier for “Medical Devices Field Safety Notice Guideline, Version 2.1”. MDR Guideline — Medical Devices Field Safety Notice, Ver 2.1 is the official identifier NHRA uses for this instrument.

Instrument
MDR
Full name
MDR Guideline — Medical Devices Field Safety Notice, Ver 2.1
Category
Vigilance
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English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
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About this regulation

Medical Devices Field Safety Notice Guideline, Version 2.1

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.

MDR Guideline — Medical Devices Field Safety Notice, Ver 2.1 is the official identifier NHRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.