The Minister of Health of Indonesia has established regulation Number 3 of 2024 about Guidelines on Halal Manufacturing Methods for Drugs, Biological Products, and Medical Devices, as well as The Inclusion of Information on The Origin of Materials for Medical Devices on 5th March 2024 and stipulated on 2nd April 2024.
To ensure the achievement of the goals to maintain and improve the degree of public health in the form of promotive, preventive, curative, rehabilitative, and/or palliative that are of quality, safe, efficient, equitable, and affordable by the public, the support of all resources in the health sector is needed. This includes pharmaceutical preparations in the form of drugs and biological products, as well as medical devices that meet the requirements of safety, efficacy, quality, and affordability. The fulfillment of quality requirements is carried out through the application of good manufacturing methods for drugs and biological products, natural medicines, and medical devices under the provisions of laws and regulations.
The Health Law also mandates that pharmaceutical preparations and medical devices must meet the provisions of halal product assurance in accordance with the obligation of halal. The implementation of halal certification obligations is further regulated through Government Regulation Number 39 of 2021 concerning Implementation of the Halal Product Assurance Sector and Presidential Regulations Number 6 of 2023 concerning Halal Certification of Drugs, Biological Products and Medical Devices carried out in stages by considering the availability of constituent materials and halal manufacturing methods.
Halal manufacturing methods are guidelines used in a series of halal drug, biological products, and medical device manufacturing activities, including the provision of ingredients, processing, storage, and packaging, which is required in the halal certification process.
Details of the types of medical device products that must be halal certified in accordance with the provisions of laws and regulations are as follows:
1. Clinical chemistry and clinical toxicology devices
2. Haematology and pathology devices
3. Immunology and microbiology devices
4. Anesthesiology devices
5. Cardiovascular devices
6. Dental devices
7. Ear, nose, and throat devices
8. Gastroenterology-urology (GU) devices
9. General hospital and personal use devices
10. Neurological devices
11. Obstetrical and gynecological devices
12. Ophthalmic Devices
13. Orthopedic devices
14. Physical medicine devices
15. Radiology devices
16. General And Plastic Surgery Devices
17. Other medical devices
Inclusion of information on the origin of ingredients for medical devices is provided in Appendix 2 as follows:- Medical devices whose materials are prohibited ingredients and not yet sourced from halal ingredients
Medical Devices whose ingredients are Haram materials and have not been sourced from halal materials. Materials derived from animals that are prohibited and have not been sourced from halal materials include carrion, blood, pigs, and/or animals slaughtered not in accordance with Sharia.
In English:
2. Medical devices whose ingredients are halal and the manufacturing process is not halal yet. Medical devices are made from halal and the production is not halal including medical devices made using materials that have been certified halal but in the process of making medical devices using or intersecting with haram ingredients.
In English:
Should you have any inquiries or require further assistance, please do not hesitate to contact us at sales@andamanmed.com or click the button below.