Medical Devices Must Be Halal Certified Starting 2026: What the New Rule Means

Starting in 2026, medical devices circulating in Indonesia are required to hold halal certification. Halal certification has long been closely associated with food, beverages, and cosmetics, but the health sector now sits squarely in the government’s regulatory focus too. Under recent policy, specific medical devices must obtain halal certification in stages, based on their risk classification, as part of a broader effort to expand Halal Product Assurance and strengthen consumer protection.

This policy confirms that medical devices need to be more than safe, high-quality, and effective, they also need to provide certainty about the halal status of their materials and production processes. For Indonesia’s majority-Muslim population, that clarity matters, since many medical products carry the potential to use animal-derived materials, alcohol, or other components whose halal status needs verification. This article breaks down the legal basis, why medical devices fall under this requirement, and how implementation actually works.

1. Introduction

Halal certification’s expansion into medical devices reflects Indonesia’s broader strategy of extending Halal Product Assurance into new strategic sectors, healthcare included. Rather than applying all at once, the requirement rolls out in stages tied to each device’s risk classification, giving manufacturers time to adjust.

2. Legal Basis for Mandatory Halal Medical Devices

The obligation rests on a clear legal foundation: Presidential Regulation No. 6 of 2023 on Halal Certification for Medicine, Biological Products, and Medical Devices. This regulation was issued as part of implementing Indonesia’s Halal Product Assurance Law, which continues to expand into various strategic sectors, healthcare among them.

The Presidential Regulation confirms that medical devices entering, circulating, and being traded in Indonesia must follow halal certification requirements in stages. The government subsequently reinforced this through Government Regulation No. 42 of 2024, which sets out the implementation stages based on each product’s risk category.

3. Risk Classes and the Phased Implementation Timeline

Halal certification for medical devices is rolled out in stages, giving the industry time to adapt. Based on Government Regulation No. 42 of 2024 on the Administration of Halal Product Assurance, this phasing is structured according to each device’s risk class.

These phase-in periods are set out in Presidential Regulation No. 6 of 2023 on Halal Certification for Medicine, Biological Products, and Medical Devices.

4. Why Medical Devices Need Halal Certification

Many people assume medical devices are entirely neutral when it comes to halal status. In reality, various medical products can contain critical materials whose origin needs to be traced in detail. Devices such as surgical sutures, catheters, certain gauzes, wound dressings, and alcohol swabs, along with additives like glycerin, gelatin, magnesium stearate, and plasticizers, can potentially originate from animal sources or other materials whose halal status must be confirmed.

If those materials come from halal animals processed according to Islamic law, the product can meet halal standards. But if they originate from pigs or other prohibited sources, the product cannot obtain halal certification.

Beyond that, halal certification also protects Muslim consumers’ right to use health products with genuine peace of mind. In this context, halal isn’t only a religious matter, it also speaks to transparency, raw-material traceability, and assurance of a clean, controlled production process.

5. Halal Critical Points in Medical Devices

Halal certification for medical devices doesn’t just evaluate the finished product. Examination runs comprehensively from upstream to downstream.

Raw Materials and Additives

Every primary and additional component needs a clear, traceable source and process, including materials of animal, chemical, or biological origin.

Lubricants, Sanitizers, and Production Facilities

Machine lubricants, facility cleaning agents, sanitizers, and even the media used to validate cleaning results in production areas all need confirmation that they’re free from prohibited or najis elements that could cause cross-contamination.

Packaging, Storage, and Distribution

Primary packaging, storage, and distribution also draw scrutiny, since each can affect a product’s halal integrity. In other words, halal status for medical devices is a comprehensive system covering the entire supply chain, not just a label on the packaging.

6. What Happens If a Device Isn’t Halal Certified Yet

The government still leaves room for products that aren’t yet halal, or that use non-halal materials, to circulate where needed, particularly under specific conditions. However, these products must clearly display a non-halal declaration on their label, packaging, or product information, in line with Presidential Regulation No. 6 of 2023.

This requirement exists to give consumers transparency, so the public can make decisions based on open, accessible information.

7. Impact on Manufacturers and the Industry

For manufacturers, this policy demands significantly greater readiness in raw-material management, internal auditing, documentation, and implementation of a Halal Product Assurance System (SJPH). Manufacturers need to review their supply chains to confirm every component meets halal standards.

Despite the challenges involved, this regulation also opens up real opportunity. Halal-certified medical devices carry stronger potential in both the domestic and global market, particularly in countries where demand for halal products continues to grow. Halal certification can also strengthen consumer trust and reinforce a company’s reputation.

8. Benefits for Consumers

For the public, this regulation delivers real, tangible benefits. Consumers gain certainty that the products they use have gone through a clear halal verification process, creating a sense of safety, comfort, and alignment with religious requirements.

More than that, this policy extends the halal lifestyle concept into the health sector, making consumer protection a matter that spans not just food consumption, but everyday medical product use as well.

9. What This Means for Foreign Medical Device Companies

For foreign medical device manufacturers and distributors selling into Indonesia, this staged mandate is worth building into market planning now, not after a deadline arrives.

• Identify your product’s risk class early — Class A products face the nearest deadline (October 2026), so confirming classification now determines your real compliance timeline
• Audit critical materials proactively — sutures, catheters, wound dressings, alcohol swabs, and additives like glycerin or gelatin are common halal-critical points worth reviewing before submission
• Build SJPH into your quality system, not alongside it — halal assurance needs to run through raw materials, facilities, lubricants and sanitizers, packaging, and distribution together
• Plan for the Non-Halal declaration pathway if needed — products using non-halal materials aren’t automatically blocked from circulation, but they must be transparently labeled
• Treat halal certification as a market advantage, not just compliance — certified products carry real appeal in Indonesia and other markets with strong halal demand

10. Conclusion

Mandatory halal certification for medical devices starting 2026 is a strategic step by the Indonesian government to strengthen the national halal ecosystem while expanding consumer protection. This regulation marks an important shift: medical devices are no longer judged on safety and quality alone, but also on the clarity of their materials and production processes.

For industry players, this is a moment to adapt and raise production standards. For consumers, it represents a genuine form of certainty and transparency that further strengthens trust in Indonesia’s health products. With early preparation, the medical device industry can be far better positioned to enter this new era of national halal certification.

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