The impact of halal certification on market access for medical devices in Indonesia – A comprehensive guide for global medical device and IVD manufacturers

English

Abstract:

Indonesia’s halal product assurance framework represents a distinct and legally binding compliance framework for global medical device and in vitro diagnostic (IVD) manufacturers seeking market access in the world’s largest Muslim-majority jurisdiction. This article by Hussein H. Mashhour, Michal Wasserbauer, Daris Salam, Mutia Asyrima Wardhani, Dian Fitriani and Alfitra Sayidina Abi provides a comprehensive regulatory guide to the halal certification process, the implementation timeframes, the criteria for mandatory applicability and formal exemption, the requirements of the Halal Assurance System (SJPH), and the strategic integration of halal compliance into existing Quality Management System frameworks. Details of common regulatory pitfalls, supply chain traceability obligations, and packaging and labelling rules are also presented.

Learning objectives:

• An understanding of the legal framework surrounding Indonesia’s Halal Product Assurance Law and its expansion to medical products, detailing the mandatory compliance scope for medical devices and IVDs (Law No. 33 of 2014).
• Clear identification of the risk-based implementation timelines for halal certification, alongside exemption criteria for purely synthetic or metal-based products.
• Actionable guidance on navigating the BPJPH certification process, covering SJPH documentation, material traceability for animal-derived components, LPH audits, and the MUI fatwa review.
• Strategic advice on integrating halal compliance into global manufacturing operations, QMS frameworks, and device labelling.

About the authors:

Hussein H. Mashhour, MD, is co-founder and Chief Operating Officer of Product Registration Indonesia, where he leads end-to-end regulatory strategy for medical devices, IVDs, supplements, and cosmetics across the Indonesian market. A licensed medical doctor and healthcare strategist with over two decades of cross-sector experience, he has led complex product registrations with Indonesia’s Ministry of Health and the National Agency of Drug and Food Control (BPOM), and advises international manufacturers on market access, distributor structuring, and regulatory compliance across the globe. He has managed multi-brand portfolios and delivered award-winning commercial performance across the Asia Pacific region. He is also a mentor on the Austrade Landing Pad programme, supporting Australian health technology companies entering Indonesia. He holds certificates in Pharmaceutical & Medical Innovation from the University of Minnesota and in Business Analytics from the University of Illinois Urbana-Champaign.

Michal Wasserbauer, PhD, is an entrepreneur and regulatory affairs specialist based in Indonesia. With more than 15 years of experience in regulatory compliance and market access across Southeast Asia, he has supported numerous healthcare and medical device companies in product registration, regulatory strategy, and commercialisation in regulated markets. He is the co-founder of Product Registration Indonesia, a leading consulting company specialising in market entry, product registration and compliance services in Indonesia and Vietnam.

Daris Salam, an accomplished finance and operations executive with over a decade of experience navigating the complexities of the Indonesian market, currently leads Product Registration Indonesia as Chief Financial Officer. Drawing on a deep technical background derived from prior hands-on roles as a controller and analyst, he holds a certificate as a Halal Supervisor. His work focuses on aligning financial discipline with operational excellence to simplify complex operational hurdles, helping international businesses scale with confidence in the region.

Mutia Asyrima Wardhani, S.Farm, Apt, is a registered pharmacist currently serving as a Regulatory Affairs Specialist at Product Registration Indonesia. She specialises in dossier compliance reviews, formula compliance evaluation, and regulatory alignment. With diverse expertise spanning over two years in packaging development and a current focus on multi-sector registrations including food and beverages, medical devices, health supplements, and halal certification, her professional work centres on navigating complex regulatory frameworks to ensure product safety and market compliance.

Dian Fitriani, S.Farm, Apt, is a Regulatory Affairs Consultant specialising in ensuring compliance with local and international regulations across regulated industries. She provides strategic guidance on regulatory requirements, supports product registration and submissions, and helps to navigate the processes for product approvals for medical devices, cosmetics, food and beverages, food supplements, halal certification, and household goods.

Alfitra Sayidina Abi is a Regulatory Affairs Specialist with experiences across the medical device, cosmetic, traditional medicine, and food and beverages sectors. Currently serving on the regulatory team at Product Registration Indonesia, Alfitra specialises in navigating complex Kemenkes and BPOM compliance frameworks. His extensive portfolio includes securing medical device distribution licences, processed food safety approvals, and vital operational credentials.

Specification:

14 pages plus covers, in English, supplied by email as a PDF.

This article will be published in the August 2026 issue of the Journal of Medical Device Regulation.