INDONESIA: REGULATION OF THE MINISTER OF HEALTH NO. 3 YEAR 2024 – ON INDONESIA'S HALAL MEDICAL DEVICE MANUFACTURING - August/September 2024

2024-09-17

Indonesia has a large Muslim population, with a growing demand for Halal products. The concept of "Halal" refers to products and practices that are permissible according to Islamic law. In recent years, there has been a growing emphasis on the production of halal products across various industries, including the healthcare sector. On April 2, 2024, the Regulation of the Minister of Health of the Republic of Indonesia No. 3 Year 2024 (Permenkes No. 3 Year 2024) has been ratified in development to halal medical devices’ (MDs) regulation in Indonesia. This article aims to provide a comprehensive overview of the key points introduced in Permenkes No. 3 Year 2024 and its implications for medical device manufacturers and related entities.

In Relation to Previous Regulations

Permenkes No. 3 Year 2024 acts as a derivate, building upon the previous framework established by Presidential Regulation No. 6 Year 2023. It provides more details on halal regulations of MDs, encompassing stringent requirements for halal ingredient utilization, facility segregation, and labeling. Furthermore, it mandates staff training and comprehensive documentation of compliance measures.

(Related news articles on previous halal medical device regulations are also referenced at the end of this page for more information)

Key Provisions of Permenkes No. 3 Year 2024

The new regulation outlines several key provisions for Halal MDs in Indonesia:

  • MDs Mandated for Halal Certification: The new regulation breaks down the list of medical device types that is mandatory to apply for halal certification if containing animal derived ingredients, which includes:
  1. 1. Clinical chemistry and clinical toxicology equipment
  2. 2. Hematology and pathology equipment
  3. 3. Immunology and microbiology equipment
  4. 4. Anesthesia equipment
  5. 5. Cardiology equipment
  6. 6. Dental equipment
  7. 7. Ear, nose, and throat equipment (ENT)
  8. 8. Gastroenterology-urology equipment (GU)
  9. 9. General and private hospital equipment (RSU&P)
  10. 10. Neurology equipment
  11. 11. Obstetrics and gynecology (OG) equipment
  12. 12. Eye equipment
  13. 13. Orthopedic equipment
  14. 14. Physical health equipment
  15. 15. Radiology equipment
  16. 16. General surgery and plastic surgery equipment
  17. 17. Other medical devices

  • Halal Manufacturing Practices: Permenkes No. 3 Year 2024 mandates strict adherence to Islamic law in the production of drugs, biological products, and MDs. This includes the use of halal ingredients, the separation of facilities for halal and non-halal products, and stringent labeling and packaging guidelines. The regulation also addresses the use of alcohol, genetic engineering, and the purification of impure substances in MDs, along with the specific guidance and resources for manufacturers to ensure compliance with Halal production standards.
  • Inclusion of Material Origin Information for MDs: If there are materials derived from animals in the product, information regarding the materials’ origin must be included at least on the primary and secondary packaging to clarify that the devices are:
  1. a) made from prohibited materials and not yet sourced from halal materials; or

b) made from halal materials and the method of manufacture is not yet halal.

The regulation also informs manufacturers to disclose the origin of materials used in their MDs through its labeling/packaging. The non-halal statement for materials and manufacturing method that are not halal includes information in the form of printing the name of the material in a different color, ensuring it is easy to see and read, not easily erased, removed, or damaged.

  • Internal Audit Checklist: To ensure compliance to halal regulations, a periodic monitoring and evaluation of a manufacturer’s halal methods are mandatory. This includes detailed records of ingredients used, processes followed, and internal audits conducted to ensure compliance. Staff members are also required to undergo training to understand the requirements of the regulation and implement them effectively.

An example of the internal audit checklist is provided in this regulation to help guide business actors in complying to the Halal regulations.

Impact on Medical Device Manufacturers

Compliance with Halal regulations may entail additional planning for medical device manufacturers; however, it also opens new market opportunities for halal-certified products, particularly in Muslim-majority countries where halal products are in demand. The regulation marks a significant shift from previous regulations and underscores Indonesia’s commitment to ensuring the quality, safety, and halal status of MDs.

Start the Halal Journey Today!

Medical device manufacturers and regulatory consultants must familiarize themselves with the requirements of the regulation and take steps to ensure compliance for the production of halal MDs in Indonesia. While there may be initial challenges in transitioning to the new regulation, the long-term benefits of producing halal-certified products are significant.

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.

Connect with us today here to unlock your medical device potential.

 

 

 

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