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Halal Labeling — Government Regulation 42/2024

Background​

Indonesia has one of the world's largest Muslim populations, and the government has implemented a comprehensive Halal Product Assurance framework. Government Regulation (PP) No. 42 of 2024 introduced a phased mandatory Halal labeling and certification timeline for medical devices — one of the most significant recent regulatory developments for device manufacturers.

Phased Compliance Deadlines​

Device ClassHalal Compliance Deadline
Class A (Low Risk)17 October 2026
Class B (Low to Moderate Risk)17 October 2029
Class C (Moderate to High Risk)17 October 2034
Class D (High Risk) and Biological Products~2039 (TBC by subsequent regulation)

Class A deadline approaching — The October 2026 Halal compliance deadline for Class A devices is approximately 12–18 months away. Manufacturers with Class A devices currently on the Indonesian market or with pending Class A registrations should initiate Halal material assessments and certification processes immediately to avoid market distribution disruptions.

What Halal Compliance Requires​

Option 1: Obtain Halal Certification The device and its supply chain undergo Halal audit and certification by a recognised Indonesian Halal certification body (under the Halal Product Assurance Organising Agency, BPJPH). The certified device may carry the official Halal logo (MUI halal logo or BPJPH-issued logo).

Option 2: Non-Halal Declaration If the device contains materials derived from sources that are not Halal under Islamic law (e.g. porcine-derived materials, certain animal-derived biologicals), full certification may not be achievable. GR 42/2024 requires that such devices:

  • Display a specific non-halal icon or text on the label
  • This allows Muslim users and healthcare institutions to make informed decisions
  • The device is not prohibited — transparency is the requirement, not exclusion

Assessing Your Devices​

Manufacturers should conduct a Halal material assessment for each device, examining:

  • Are any materials derived from animal sources?
  • If so, what species? (Porcine derivatives are the most common concern)
  • Are any alcohol-based substances used in the device or packaging?
  • Are any materials derived from microbial fermentation using non-Halal substrates?

A complete Bill of Materials (BoM) with material origins is the starting point for this assessment.

Practical Preparation Steps​

  1. Compile Bill of Materials for all Indonesian-registered devices
  2. Identify any animal-derived materials and their species/source
  3. Assess feasibility of reformulation (where applicable and practical)
  4. Engage an Indonesian BPJPH-recognised Halal certification body
  5. Begin supply chain documentation for Halal certification audit
  6. If non-Halal materials cannot be replaced, design the required non-Halal declaration label elements

Impact on Existing NIEs​

If Halal labeling changes are made to an already-registered device, this constitutes a label change. Depending on the extent of the change, a change notification (Perubahan) or, in significant cases, a dossier update may be required through Regalkes. Plan label changes and regulatory submissions in parallel with Halal certification activities.

The non-Halal declaration must be clearly visible on the device label and packaging in Bahasa Indonesia and/or English. Common formats include a text statement such as "Mengandung bahan non-Halal" (Contains non-Halal materials) or a standardised non-Halal icon (if defined by BPJPH). The statement should identify the specific non-Halal material (e.g., "Contains porcine-derived gelatin") to provide transparency to end-users and healthcare institutions.

The Halal Product Assurance Organising Agency (BPJPH — Badan Penyelenggara Jaminan Produk Halal) maintains a list of accredited Halal certification bodies (LPH — Lembaga Pemeriksa Halal) that are authorised to conduct audits and issue Halal certificates. Manufacturers should verify that their chosen certification body is BPJPH-accredited before engaging. The certification process typically requires a complete supply chain audit and documentation of material sources, production conditions, and storage/handling procedures.