Ministry of Health EvaluationEvaluation Guidelines 2020
Evaluation Guidelines 2020 is the official Kemenkes identifier for “Guidelines for Evaluation of Medical Devices and In Vitro Diagnostics”. Evaluation Guidelines 2020 is the official identifier Kemenkes uses for this instrument.
- Instrument
- Evaluation
- Full name
- Evaluation Guidelines 2020
- Category
- Registration
- Authority source
- English
- Readable HTML
- 1 language version
- Published
- 2020
- Effective
- 2020
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Guidelines for Evaluation of Medical Devices and In Vitro Diagnostics
Official 2020 bilingual evaluation guideline (ISBN 978-623-301-025-2, 226 pages; Indonesian authoritative with English translations) issued by the Directorate of Medical Device Evaluation under Permenkes 62/2017: legal basis, definitions, and the full registration procedure — User ID/password application, new product-license applications (evaluation requirements by risk class), renewals, variations, renewal-with-variation, technical development and consultation — plus Lampiran 1-10 (requirement matrices by application type, document lists, forms, contacts, evaluation flows, and the application flowchart). Ingested BAB I-III with all numbered subsections and the ten annexes. Still served as the evaluation guidance on the official Regalkes portal; note its parent instrument PMK 62/2017 is marked repealed by Permenkes 5/2026 on the Ministry JDIH (see EXP-21 for the current legal family).
Evaluation Guidelines 2020 is the official identifier Kemenkes uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.