Kemenkes DocumentPP 64/2019 — selected medical-device fee annex pages
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
PP 64/2019 fee annex — medical-device licensing, changes, renewal and certificate pages is published by Ministry of Health. This document is identified by its title; no separate official document code is recorded.
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PP 64/2019 fee annex — medical-device licensing, changes, renewal and certificate pages
Six selected complete physical pages from the full 241-page official BPK-hosted annex: identity/cover page 1 and pages 160–164, which contain medical-device licensing and certificates, distribution-permit changes, device marketing-permit issue/renewal/change/renewal-with-change rows, and production certificates. Full original PDF and full native extraction remain archived. Whole source page context includes neighboring pharmaceutical and PKRT rows; those are not device requirements. Original printed marketing-permit classes I–III and production-certificate classes A–C are preserved separately and are not mapped to current risk classes A–D. Page images govern damaged original OCR; no correction or current 2026 fee/IVD applicability/question completion is asserted. This is not the whole annex or a separate new law from its companion body.
This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.