ZAMRA ZAMRAZAMRA/MA/GUD/0003
ZAMRA/MA/GUD/0003 is the official ZAMRA identifier for “Guidelines for Grant of Marketing Authorisation of In-Vitro Diagnostic Medical Devices for Human Use”. ZAMRA/MA/GUD/0003 is the official identifier ZAMRA uses for this instrument.
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- ZAMRA/MA/GUD/0003
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Guidelines for Grant of Marketing Authorisation of In-Vitro Diagnostic Medical Devices for Human Use
ZAMRA/MA/GUD/0003, the IVD marketing-authorisation guideline, and the IVD counterpart to the non-IVD guideline. It runs from the general requirements and the application through screening, evaluation, laboratory analysis and GMP inspection to the grant, validity, amendment and renewal of an IVD marketing authorisation, with the IVD classification rules and the application compilation at 1.14 and 1.15. One thing about the copy is recorded rather than repaired: its own cover version-history block states "Version 2 published for implementation" with no date, while the running footer on every page reads "V 1.0". The version stated here is the footer's, which is the one the document repeats on every page and the one the round-207 registry row carries.
ZAMRA/MA/GUD/0003 is the official identifier ZAMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.