A regulatory gap analysis of ISO 14155:2026 and Indonesia’s Permenkes 63/2017 on clinical investigations to support harmonisation
£69.00
Identify the regulatory gaps between ISO 14155:2026 and Indonesia’s clinical investigation requirements, and the key recommendations for aligning with international best practice
English
Abstract:
ISO 14155:2026, the fourth edition of the international standard for Good Clinical Practice (GCP) in medical device clinical investigations, introduces significant updates reflecting advances in clinical methodology, digital health, and evolving regulatory expectations globally. Peraturan Menteri Kesehatan Republik Indonesia Nomor 63 Tahun 2017 (Permenkes 63/2017) constitutes Indonesia’s national framework for GCP for medical devices. In this article, Ivon Septriyana and Agus Gunadi present a comprehensive gap analysis comparing the requirements of ISO 14155:2026 with those of Permenkes 63/2017, with the aim of identifying regulatory gaps and providing evidence-based recommendations to support the revision of Indonesia’s legislation. The authors conducted a clause-by-clause comparison across all normative clauses and selected annexes of ISO 14155:2026 and corresponding provisions in Permenkes 63/2017. Of the 107 requirements that were analysed, a total of 40 gaps were identified: nine representing entirely absent provisions and 31 representing partially addressed requirements. Beyond identifying divergences, the article also examines the rationale underlying these developments and positions Indonesia within the wider international regulatory context. Permenkes 63/2017 demonstrates a strong regulatory foundation; however, targeted revisions are required to strengthen alignment with the 2026 edition of ISO 14155. The recommendations provided are intended to support the development of an updated Indonesian national Regulation that reflects international best practice in medical device clinical investigation.
Learning objectives:
- Identify systematically provisions in ISO 14155:2026 that are absent or only partially addressed in Permenkes 63/2017.
- Classify and prioritise these gaps based on the magnitude of the gap and potential impact on subject safety, data integrity and regulatory compliance.
- Understand the rationale for the 2026 changes and place the Indonesian findings in an international regulatory context.
- Provide actionable, evidence-based recommendations to support the development of a revised national Regulation for medical device clinical investigations in Indonesia.
About the authors:
Ivon Septriyana is a Graduate Student of the Faculty of Medicine and Health Sciences, Universitas Kristen Krida Wacana (UKRIDA), Jakarta Barat 11510, Indonesia.
Agus Gunadi is a Graduate Student of Clinical Epidemiology, Faculty of Public Health, Universitas Indonesia, Depok 12345, Indonesia.
Specification:
27 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the November 2026 issue of the Journal of Medical Device Regulation.
