ZAMRA ZAMRAZAMRA/MA/GUD/0001
ZAMRA/MA/GUD/0001 is the official ZAMRA identifier for “Essential Principles of Safety and Performance of Medical Devices”. ZAMRA/MA/GUD/0001 is the official identifier ZAMRA uses for this instrument.
- Instrument
- ZAMRA
- Full name
- ZAMRA/MA/GUD/0001
- Category
- General
- Authority source
- English
- Readable HTML
- 28 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.
Essential Principles of Safety and Performance of Medical Devices
ZAMRA/MA/GUD/0001, the essential-principles guideline, and the substantive safety-and-performance standard a Zambian device application is assessed against. It follows the IMDRF GRRP WG/N47 FINAL: 2018 structure: the principles applicable to all devices and IVDs, then the principles applicable to devices other than IVDs, then those applicable to IVDs. It cites IMDRF/GRRP WG/N040:2017 in its references, and the running footer carries "31 October 2018". Two appendices are ingested with it (use of standards in meeting the essential principles, and guidance on the essential principles).
ZAMRA/MA/GUD/0001 is the official identifier ZAMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.