NMPB RFmRFm/R/01/01, Issue 3 (1 August 2019)
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
RFm/R/01/01, Issue 3 (1 August 2019) is the official NMPB identifier for “Requirements for the registration of Foreign Plant — medical-device section4”. RFm/R/01/01, Issue 3 (1 August 2019) is the official identifier NMPB uses for this instrument.
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Requirements for the registration of Foreign Plant — medical-device section4
Complete one-page NMPB controlled requirements, RFm/R/01/01 issue 3, issued 1 August 2019, with printed expiry of 1 August 2022. General section A requires an application and authorized translation for documents outside English/Arabic. Section B.4 expressly addresses medical-device foreign plants: origin manufacturing licence with listed geographic exceptions, origin GMP certificate or ISO 13485, CE certificate as support, and the literal ambiguous line “Document for European countries.” No missing document type is invented for that line. Medicine, supplement and cosmetics sections B.1–3 are retained only as full-page context and are not generalized to MD/IVD. The current controlled copy, interpretation of B.4(4), geographic exceptions and requirements in 2026 remain unverified.
RFm/R/01/01, Issue 3 (1 August 2019) is the official identifier NMPB uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.