Indonesia medical device regulations

Permenkes No. 5 Tahun 2026 tentang Perbekalan Kesehatan — the current Kemenkes instrument for pharmaceuticals and medical devices, promulgated in Berita Negara 2026 No. 283 (established 17 April 2026, promulgated 4 May 2026, 52 pages). Implements PP 28/2024 and repeals PMK 62/2017, moving distribution permits (izin edar) into the perbekalan kesehatan regime; its transitional articles (BAB IX, Pasal 122–125) keep specified PMK 62/2017 provisions in force pro tempore. Ingested Bab I–X, Pasal 1–126, and the pengundangan block from the official Ministry JDIH PDF.

PP No. 42 Tahun 2024 tentang Penyelenggaraan Bidang Jaminan Produk Halal — the controlling halal instrument for medical devices, implementing UU 33/2014 (as amended by UU 6/2023 Cipta Kerja) and repealing PP 39/2021 (Lembaran Negara 2024 No. 229, TLN No. 6998; established and promulgated 17 October 2024). Pasal 161(1)(g)–(i) phase the certification obligation for alat kesehatan by risk class: kelas A by 17 October 2026, kelas B by 17 October 2029, kelas C by 17 October 2034 (no separate kelas D deadline appears); Pasal 126 assigns the BPJPH–Kemenkes cooperation scope for alat kesehatan and perbekalan kesehatan rumah tangga; Pasal 162 lets obat/biologi/alkes with non-halal starting materials circulate with origin labelling pending a further Peraturan Presiden. Ingested Bab I–XVII, Pasal 1–198, the pengundangan block, and the Penjelasan from the official salinan scan mirrored on the Kemenkoinfra JDIH (the scan's OCR layer carries disclosed digit/header artefacts; the deadline years in Pasal 161 are digit-clean).

Official CDAKB certification portal. Effective July 1, 2024, CDAKB certificate is mandatory for distributors to register new medical products. MOH audits distributor facilities.

Comprehensive information system for pharmaceutical and medical device regulations, including registration requirements and regulatory updates.

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).

Official online portal for medical device registration, distribution permits, and regulatory submissions to Indonesia Ministry of Health.

Historical PMK No. 62 Tahun 2017 on distribution permits (izin edar) for medical devices, IVDs, and household health supplies. Ingested Bab I–XIII, Pasal 1–68, and Lampiran I–II from the official Regalkes PDF. Established 29 December 2017 and promulgated 12 January 2018 (Berita Negara 2018 No. 82). Superseded by Permenkes No. 5 Tahun 2026 (id-permenkes-5-2026), whose transitional articles keep specified PMK 62/2017 provisions in force pro tempore.

Ditjen Kefarmasian dan Alat Kesehatan classification guide (September 2016), the original Indonesian authority expression of the AMDD-harmonized rules: Ketentuan 1-22 for medical devices (sec-3-1) and PERATURAN 1-7 for IVD (sec-3-2), classes A-D. Replaces the former AHWP third-party copy (ahwp.info unreachable). The statutory classes are now Permenkes 5/2026 Pasal 55; this pedoman remains the rule-level detail. Exact official PDF ingested as sec-1 through sec-4 plus Annexes 1-3.

Official Regalkes Guideline Penentuan Kelas table: 2,943 authority-published product-type rows with device/IVD context, category, subcategory, product name, optional HS code, numeric class, and ASEAN risk class. This is product-level classification evidence; id-classification remains the rule-level source.