Countdown to Indonesia’s New Halal Certification Rules: How Medical Device, Food and Drug Companies Should Prepare

From 18 October 2026, the scope of mandatory halal certification in Indonesia will expand further to cover cosmetics, chemical products, household health products (PKRT), certain consumer goods and Class A risk medical devices, among others.

This is not only a concern for Indonesian manufacturers; it is also quietly affecting companies that “seem” unrelated to halal certification – such as overseas manufacturers supplying industrial raw materials like nonwovens, fibers and textile materials to Indonesian customers, and companies exporting drugs, natural medicines, health supplements and medical devices to Indonesia.

Many raw material manufacturers’ first reaction is: we don’t sell directly to Indonesian consumers and have no Indonesian consumer brand of our own, so halal certification shouldn’t concern us.
But reality is often different. Halal certification audits never look only at the finished product, but also at the raw materials and excipients used to make it. When an Indonesian downstream manufacturer – for example of tissues and hygiene products, wet wipes and personal care products, household cleaning products or certain healthcare products – applies for halal certification of its products, the audit may well trace back to upstream raw material suppliers and require:

  • Halal certificates for raw materials
  • Material composition or product specifications
  • Animal-origin declarations
  • Raw material manufacturer information
  • Production process information
  • Raw material source declarations
  • Information on processing aids or additives

In other words, the question is not “must my raw material itself be certified”, but “will my Indonesian customer need me to provide halal documents when it applies for halal certification of its finished product?”

A business scenario worth considering

Imagine two raw material suppliers with similar products:

  • Supplier A: can provide halal certificates and supporting documents at any time;
  • Supplier B: cannot provide any halal-related documents.

If the Indonesian customer’s finished product is undergoing or planning halal certification, it’s not hard to guess which supplier makes the customer’s compliance process smoother and is more likely to be preferred. Halal readiness is gradually turning from a “bonus” into an implicit threshold some customers use to screen suppliers.

2. Drugs, Natural Medicines, Health Supplements and Medical Devices: A Distinct Certification Logic

For pharmaceutical and medical device companies, determining Indonesian halal compliance is more complex than for general consumer goods; you cannot simply conclude that “a Class A risk medical device must always be certified”.
The main current legal bases include the amended Halal Product Assurance Law (Law No. 33 of 2014), Government Regulation No. 42 of 2024, Presidential Regulation No. 6 of 2023, Minister of Health Regulation No. 3 of 2024 and the current implementing requirements of BPJPH (the Indonesian Halal Product Assurance Agency).

Important: the halal obligation generally applies to medical devices derived from animals and/or containing animal components. A product being classified as Class A risk does not by itself mean it must be halal-certified – this must still be determined product by product.

For this reason, halal projects for drugs and medical devices should not be seen as a one-off “mark registration”. A defensible certification conclusion needs a complete chain of evidence covering the product itself, its raw materials/excipients, and the production management and control system that maintains halal integrity. A halal certificate is issued for a specific approved product scope, and evidence on raw materials and production processes is the foundation for that scope.
Countdown to Indonesia's New Halal Certification Rules: How Medical Device, Food and Drug Companies Should Prepare – Figure 1

3. Three Questions Companies Can Ask Themselves

  • Do our customers have products that are entering or planning to enter the Indonesian market?
  • Might customers ask us to provide halal raw materials or halal-related documents in future?
  • If a customer asks for halal documents, are we ready now?

Companies don’t need to wait until customers make formal, urgent requests. A safer approach is to do an initial assessment first – understanding whether halal requirements apply to your products, which documents are needed and which certification route fits – before deciding on next steps.
Countdown to Indonesia's New Halal Certification Rules: How Medical Device, Food and Drug Companies Should Prepare – Figure 2

4. How EVERBIZ Can Help

EVERBIZ has long provided practical support on Indonesian halal compliance for overseas manufacturers and raw material suppliers, including:

  • Initial halal applicability assessment – determining whether products fall within mandatory or recommended certification scope
  • Product and raw material review, identifying gaps in raw materials/excipients and production processes
  • Halal certification route analysis, including BPJPH halal certification and eligible foreign certification routes
  • Assessment of the applicability of existing overseas halal certificates
  • Preparation and review of halal application documents
  • Preparation and coordination support for audits/on-site inspections
  • Follow-up of corrective actions on audit findings and coordination within the agreed scope
  • Guidance on ongoing maintenance of halal labels, marks and certification scope

Before formally applying for certification, we recommend completing an assessment of regulatory applicability and halal readiness, to avoid entering the formal application process before product documents, supplier evidence and production controls are adequately prepared – which can lengthen the audit cycle or lead to repeated requests for more information.
Generally, once documents are complete and accurate and the application is formally submitted, a project is expected to take about 2 months, depending on audit scheduling, the processing progress of the authority or certification body, and how quickly audit findings are closed – this is an estimate based on project experience, not a commitment to official processing times.

5. Summary

Indonesia is a market of over 245 million people, about 87% of whom are Muslim, and halal compliance capability is evolving from a single “market entry threshold” into an issue shared across the supply chain. Whether you are a brand selling directly to Indonesian consumers, an upstream raw material supplier, or a drug or medical device manufacturer, understanding your products’ halal applicability and preparing documents in advance is a practical way to meet future customer requirements and stay competitive.
If you would like to learn more about the halal applicability of your products in Indonesia or assess a suitable certification route, contact EVERBIZ – we’ll be happy to give tailored advice based on your product portfolio, manufacturing locations and specific needs.

Regulatory note: BPJPH has confirmed that the mandatory halal certification phase from 18 October 2026 covers cosmetics, chemical products, household health products (PKRT), certain consumer goods and Class A risk medical devices, including foreign/imported products; the specific halal route should still be determined product by product.

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Countdown to Indonesia's New Halal Certification Rules: How Medical Device, Food and Drug Companies Should Prepare – Figure 3

About Us

COMPANY INTRODUCTION
EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria), Thailand, Vietnam, Singapore and Malaysia, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).
Countdown to Indonesia's New Halal Certification Rules: How Medical Device, Food and Drug Companies Should Prepare – Figure 4

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Countdown to Indonesia's New Halal Certification Rules: How Medical Device, Food and Drug Companies Should Prepare – Figure 5
Countdown to Indonesia's New Halal Certification Rules: How Medical Device, Food and Drug Companies Should Prepare – Figure 6

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