Indonesia’s Halal Regulation Update
On 27 June 2023, the Ministry of Health (MoH) of Indonesia invited relevant stakeholders to gather
input on the Draft Guidelines for Halal Manufacturing Practices for Drugs, Biological Products, and
Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical
Devices. Andaman Medical Indonesia was amongst those who were invited by the MoH, as a
distributor who conducts distribution process from medical devices originating from animals or
containing animal materials. Learn more here.
This regulation, consisting of 6 articles and 2 appendixes, will be signed by the Minister of Health in
Indonesia. The scope of halal certification in medical devices and non-halal labelling is regulated in
Non-halal labelling itself becomes imperative since it is stated in articles 92 – 94 in Governmental
Regulation No. 39 Year 2021. Highlighted articles in the draft are Article 3 and 5 which mentioning
the scope of halal certification that is only applicable for medical devices originating form animals
and/or containing animal elements and non-halal information obligatory for medical devices
originate from prohibited material and/or the method of manufacturing is not halal yet.
There are 2 types of non-halal labelling are regulated by this draft of regulation.
1. ‘Bahan Tidak Halal’ label or in English it would be ‘Non-halal ingredients’ for Medical Devices
whose ingredients are Haram materials and have not been sourced from halal materials.
2. ‘Proses Belum Halal’ label or in English it would be ‘The process is not lawful’ for Medical
Devices whose ingredients are Halal, and the manufacturing method is not Halal yet.
Halal Obligation including the labelling requirement is implemented in stages based on Class Risk
according to Government Regulation No 39 Year 2021 and Presidential Regulation No 6 Year 2023.
– 17 Oct 2026: Class A medical devices
– 17 Oct 2029: Class B medical devices
– 17 Oct 2034: Class C medical devices
– 17 Oct 2039: Class D medical devices
If you have any queries regarding this draft, please contact us or click the button below.