Halal Certification for Medical Devices in Indonesia: Complete Guide for Global Manufacturers in 2026

As the world’s largest Muslim-majority country, Indonesia is shaping the global direction of the Halal industry, extending far beyond food and cosmetics. Today, medical devices are part of this fast-evolving framework.

Global manufacturers from the U.S., Europe, and Asia are beginning to understand that Halal certification for medical devices in Indonesia is no longer optional, but it’s a strategic necessity.

Indonesia’s Halal Product Assurance Law (Law No. 33/2014) mandates Halal certification for products entering its market, including medical devices that contain, or may contain, animal-derived components. This new requirement offers foreign manufacturers both an opportunity and a challenge: an opportunity to enter an expanding medical device market worth over $13 billion, and a challenge due to the intricate documentation, audits, and language barriers.

To navigate this landscape successfully by understanding the Indonesian Halal system through the BPJPH halal certification process is crucial.

In this complete guide, we’ll explore the legal framework, key requirements, step-by-step certification, and why working with experts like Product Registration Indonesia helps global manufacturers achieve compliance faster and with confidence.

Understanding Indonesia’s Halal Regulation Framework

Halal certification in Indonesia operates under a dual system that integrates religious, regulatory, and technical elements.

• Legal Foundation: The Halal Product Assurance Law (Law No. 33/2014) and Government Regulation No. 39/2021 outline mandatory Halal certification for all products distributed in Indonesia.
• Regulatory Body: The process is governed by BPJPH (Badan Penyelenggara Jaminan Produk Halal) under the Ministry of Religious Affairs. BPJPH handles the administrative side, receiving applications, coordinating audits, and issuing certificates.
• Audit & Assessment: The technical audit is carried out by accredited Halal Inspection Bodies called LPH (Lembaga Pemeriksa Halal), often supervised by LPPOM MUI, which ensures the Halal status of materials and production processes.

Halal certification for medical devices is currently being phased in until 2026, with a focus on devices that contain or come into contact with animal-derived materials.

In short, Halal compliance for medical devices in Indonesia is a shared responsibility: BPJPH handles certification, LPH audits the process, and manufacturers ensure all documents and materials meet Halal standards.

Why Halal Certification Matters for Medical Device Companies

Many foreign manufacturers initially assume Halal certification is only relevant to food or cosmetics. However, medical devices are equally significant for Muslim-majority markets like Indonesia because they directly contact human tissue or bodily fluids.

Here’s why Halal certification is vital for the medical device industry:

1. Regulatory Compliance – As part of the Halal product registration Indonesia system, Halal certification is now embedded into the country’s national regulatory framework. Devices that fail to meet Halal requirements risk rejection or restricted distribution.
2. Market Access Advantage – Certified products are more easily accepted by hospitals and clinics, especially those under Indonesia’s public health insurance program (BPJS Health).
3. Reputation and Trust – Halal certification reinforces product credibility in both local and global Muslim markets. It signals ethical manufacturing and transparency.
4. Tender Eligibility – Many government tenders and e-Katalog listings under the Ministry of Health now give preference to Halal-certified products.
5. Long-Term Business Strategy – Companies that adopt Halal standards early are more likely to secure stable partnerships and brand loyalty in Indonesia and neighboring ASEAN countries.

By integrating Halal certification into your compliance strategy, you not only meet regulations but also gain a sustainable competitive advantage.

Classification: Which Medical Devices Require Halal Certification?

Under current BPJPH and Ministry of Health guidelines, medical devices that require Halal certification include those:

• Containing animal-derived ingredients such as collagen, gelatin, or enzymes.
• Having direct contact with the body, blood, or tissue.
• Used in invasive or surgical procedures.

Examples of devices requiring certification:

• Surgical sutures, implants, orthopedic prosthetics.
• Wound dressings or hemostatic sponges containing gelatin.
• Diagnostic kits with biological reagents of animal origin.
• Dental materials, catheters, syringes with animal-based lubricants.

Devices that may be exempted:

• Non-invasive equipment (MRI, CT scanners, monitors).
• Devices made entirely of synthetic or metal components.

Note: The requirement is being enforced gradually based on product class (A to D) and risk profile. Full enforcement for all relevant medical devices is expected by October 2026.

Step-by-Step Halal Certification Process for Medical Devices

Step 1: Pre-Assessment & Classification

Determine whether your device falls under the Halal certification requirement. This involves assessing raw materials, components, and contact levels with the human body.

Step 2: Document Preparation

Compile all regulatory documents required for BPJPH halal certification. The main dossier includes:

• Halal Assurance System (HAS 23000) manual.
• Detailed material and ingredient lists.
• Supplier declarations and Halal certificates for raw materials.
• GMP / ISO 13485 certificate (legalized).
• Certificate of Free Sale (CFS) from the country of origin.
• Manufacturing flowchart showing segregation of non-Halal materials.

Step 3: Application Submission via SiHalal (BPJPH System)

Manufacturers must register through SiHalal, accessible at halal.go.id. The portal requires filling in product data, uploading legalized documents, and paying the official government fee (PNBP).

Step 4: Halal Audit by LPH

An accredited Halal Inspection Body (LPH) reviews your application and conducts an audit. For foreign manufacturers, the audit may involve:

• Document review and factory inspection (onsite or virtual).
• Verification of materials, manufacturing line, and sanitation procedures.
• Audit report submission to BPJPH.

Step 5: Certificate Issuance

Once approved, BPJPH issues the official Halal Certificate valid for four years.

Step 6: Post-Certification Maintenance

You must maintain a valid Halal Assurance System (HAS), submit periodic reports, and renew certification before expiry.

Required Documents for Halal Certification of Medical Devices

Documentation is the backbone of Halal product registration in Indonesia. Here’s a checklist of the key requirements:

Many global manufacturers already hold FDA or CE documents, but these do not automatically fulfill BPJPH requirements; they must be localized and legalized.

Cost and Timeline Overview

Halal certification cost in Indonesia varies depending on product type, risk class, and chosen inspection body. Here’s a general overview:

Overall, the certification process takes 3–6 months on average. Common delays occur due to incomplete documentation, lack of translated materials, or coordination issues with suppliers.

Maintaining Halal Compliance After Certification

Obtaining Halal certification is only the beginning. To maintain compliance, manufacturers must:

• Conduct internal audits annually to verify Halal processes.
• Notify BPJPH of any changes in formulation, supplier, or manufacturing site.
• Renew certification before expiration (valid for four years).
• Implement continuous Halal Assurance System (HAS) monitoring.

We offer Halal Compliance Monitoring Services for ongoing assistance to ensure documentation, renewals, and post-market obligations are met without disruption.

Common Challenges Faced by Foreign Manufacturers

Foreign medical device producers often face unique challenges in meeting Halal standards in Indonesia:

1. Material Origin Uncertainty – Difficulty identifying animal-derived components in complex supply chains.
2. Document Legalization – Delays in embassy legalization of CFS, GMP, and LoA.
3. Translation Barriers – All materials, labels, and IFUs must be in Bahasa Indonesia.
4. System Familiarity – Navigating SiHalal and coordinating with BPJPH or MoH can be overwhelming.
5. Different Regulatory Logic – FDA/CE approvals focus on safety and performance, while BPJPH adds a religious compliance layer.

🟩 Tip: Working with a regulatory partner like Product Registration Indonesia helps minimize delays and avoid multiple audit revisions. Our team ensures every submission meets both BPJPH and MoH standards on the first attempt.

Halal certification is transforming Indonesia’s medical device landscape, from a voluntary practice to a legal requirement.

By understanding Indonesia’s framework, preparing documentation early, and collaborating with local experts, companies can achieve faster market access and greater brand credibility.

Why Choose Product Registration Indonesia (PRI)

Product Registration Indonesia is a trusted regulatory consulting firm with 15+ years of experience helping international companies register and certify products across sectors, especially medical devices.

• Comprehensive Halal & Regulatory Service: From pre-assessment, dossier review, BPJPH application, to audit liaison.
• Medical Expertise: Led by Dr. Hussein H. Mashhour, a healthcare strategist with a decade of experience navigating Indonesia’s health and Halal sectors.
• Local Representation & License Holding: PRI can act as your local license holder, enabling smooth registration without tying you to a single distributor.
• Efficiency & Accuracy: Reduced processing time through pre-verified documentation and regulator coordination.

Led by Dr. Hussein H. Mashhour, a regulatory and medical expert with more than 15 years of experience in Indonesia’s compliance landscape, PRI ensures that your medical devices enter Indonesia smoothly, ethically, and fully compliant.

Partnering with PRI means full compliance without complexity. Whether you’re in the U.S., Europe, or China, we ensure your products meet all Halal certification requirements seamlessly.