NHRA MDRMDR Guideline — Medical Devices Reporting, Ver 1.1
MDR Guideline — Medical Devices Reporting, Ver 1.1 is the official NHRA identifier for “Medical Devices Reporting Guideline, Version 1.1”. MDR Guideline — Medical Devices Reporting, Ver 1.1 is the official identifier NHRA uses for this instrument.
- Instrument
- MDR
- Full name
- MDR Guideline — Medical Devices Reporting, Ver 1.1
- Category
- Vigilance
- Authority source
- English
- Readable HTML
- 0 articles · 1 language version
- Published
- —
- Effective
- —
Open a language version
Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Medical Devices Reporting Guideline, Version 1.1
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.
MDR Guideline — Medical Devices Reporting, Ver 1.1 is the official identifier NHRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.