Indonesia: Implementation of Halal Product Assurance for Medical Devices Circulating in Indonesia

The Government of Indonesia has introduced Government Regulation No. 42 of 2024 on Halal Product Assurance, enhancing and expanding on the prior Government Regulation No. 39 of 2021. This regulation aims to provide legal certainty and assurance to the public regarding the halal status of products available within Indonesia. All products that are circulated, supplied, and traded within Indonesia must obtain halal certification, with the exception of products derived from prohibited (haram) ingredients. These exempted products must be clearly labelled with non-halal information.

Key Details of the Halal Product Assurance Implementation

The Halal Product Assurance Organizing Agency (BPJPH) has been designated by the government to oversee the implementation of halal assurance for products in collaboration with relevant ministries and agencies, including the Ministry of Health. BPJPH’s role includes:

  • Supervision of Halal Certificates and Labels for medical and household health products
  • Facilitation of halal certification for medical devices and household health supplies
  • Recommendations for revocation of Halal Certificates and Labels if necessary
  • Additional Responsibilities related to the administration of Halal Product Assurance

Highlights of Government Regulation No. 42 of 2024

Key provisions within this regulation include:

  1. Implementation of Halal Product Assurance: Managed by BPJPH to ensure compliance and oversight.
  2. Separation Requirements: Locations, tools, and processes for halal and non-halal products must be clearly separated.
  3. Halal Inspection Procedures: Establishment, accreditation, and revocation procedures for Halal Inspection Agency approvals.
  4. Rights and Obligations of business actors, including guidelines for Halal Supervisors.
  5. Application and Renewal: Procedures for applying and renewing halal certificates under BPJPH.
  6. Micro and Small Business Certification: Simplified certification process for eligible micro and small businesses.
  7. Labeling Requirements: Mandatory inclusion of Halal Labels and information on non-halal products.
  8. BPJPH’s Oversight Role: Supervision of Halal Product Assurance and collaboration with relevant ministries.
  9. Certification for Foreign Products: Product registration and certification requirements for foreign products.
  10. Halal Certification Stages: Defined stages and types of halal-certified products, including medical devices.
  11. Public Participation: Involvement of the public in ensuring compliance with Halal Product Assurance.
  12. Administrative Sanctions: Penalties for non-compliance with Halal Product Assurance.

Halal Certification Timeline for Medical Devices

According to Article 161, the timeline for mandatory halal certification of medical devices remains consistent with previous regulations (Government Regulation No. 39 of 2021):

  • Risk Class A Medical Devices: October 17, 2021, to October 17, 2026
  • Risk Class B Medical Devices: October 17, 2021, to October 17, 2029
  • Risk Class C Medical Devices: October 17, 2021, to October 17, 2034
  • Non-Halal Medical Devices: Medical devices, pharmaceutical, and biological products not sourced from halal materials or produced through non-halal processes, as specified by law.

Business entities may apply for halal certification for non-food, non-beverage products, including non-slaughtered products, before the specified staging period mentioned above.

Additional Resources and Contact Information

For more information about this regulation, please refer to the detailed document Salinan_PP_Nomor_42_Tahun_2024.pdf (Indonesian only).

Should you have further inquiries or need assistance, please reach out to us at sales@andamanmed.com or click the button below.

Sign up for our regulatory roundup delivered once a month to your inbox



Scroll to Top

Stay Ahead in Southeast Asia's Medical Device Market!

Subscribe to our Newsletter

Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!

Contact Us