ZAMRA ZAMRAZAMRA guideline Version 2, 21 June 2024
ZAMRA guideline Version 2, 21 June 2024 is the official ZAMRA identifier for “Guidelines on Application for Grant of Marketing Authorisation of Non In-vitro Diagnostic Medical Devices for Human Use”. ZAMRA guideline Version 2, 21 June 2024 is the official identifier ZAMRA uses for this instrument.
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Guidelines on Application for Grant of Marketing Authorisation of Non In-vitro Diagnostic Medical Devices for Human Use
The core ZAMRA device marketing-authorisation guideline and this market's lead instrument. Its cover version history reads "Version 1 draft 21st May, 2021 / Version 1 released for comment 17th September, 2021 / Version 2 published for implementation 21st June, 2024"; the copy states no ZAMRA document number, so the version and date are what identify it. It sets the general requirements on the applicant and the dossier, the product information, the classification of a non-IVD device, and the technical information required for each class, and it carries the application form and the product-dossier checklist as annexes (ANNEX I with Parts I to III, ANNEX II, Annex III and Annex IV, which is ZAMRA's 1.xx-numbered dossier item index). It is the instrument that states the device marketing-authorisation requirement in Zambia today.
ZAMRA guideline Version 2, 21 June 2024 is the official identifier ZAMRA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.