Why Are Medical Devices Required to Have BPJPH Halal Certification Starting in 2026?

BPJPH halal certification is now mandatory for the medical device industry, as per Government Regulation No. 42/2024. Starting in 2026, Class A medical devices must be halal for regulatory compliance, consumer protection, and product safety assurance, free from substances that are haram, and in accordance with Sharia law. This article discusses the critical points of halal certification for medical devices and LPPOM’s support in the certification process. 

Halal certification for medical devices is now a crucial concern, given the increasing public awareness of products used daily, including those that come into direct contact with the body. To support the fulfillment of safety, quality, and efficacy requirements for medical devices, the Indonesian Ministry of Health, through the Directorate of Production and Distribution of Medical Devices, held an online Technical Strengthening activity to fulfill the Safety, Quality, and Benefits of In Vitro Diagnostic Medical Devices for Marketing Authorizations on September 25, 2025. 

On this occasion, Mulyorini Rahayuningsih Hilwan, a member of the Halal Audit Quality Board LPH LPPOM, discussed “Critical Points of Halal Materials in the Halal Product Process for Medical Devices.” In her opening presentation, she emphasized the importance of understanding raw materials, additives, and auxiliary materials used in the production of medical devices. 

Raw materials and additives are all materials used to produce a product. They are part of its composition, while auxiliary materials are used to assist the manufacturing process but are not part of the final composition. Furthermore, other aspects such as primary packaging, lubricants, cleaners, and cleaning validation media that come into direct contact with the product are also important considerations in halal certification. 

In the context of Islamic law, the principles of intifa emphasize that the use of pork and its derivatives is prohibited. Regarding this, Mulyorini stated, “For materials deemed haram, Allah will certainly provide alternatives.” This statement emphasizes that any material deemed problematic for halal certification has a solution that the industry can take. 

Why Must Medical Devices Be Halal? 

Some medical devices may contain ingredients whose halal status is critical, such as animal derivatives or ethanol. Some products come into direct contact with the human body and are even manufactured in the same facilities as products that are not free from pork. 

Based on a study by the Indonesian Council of Ulama (MUI) Fatwa Commission team and GAKESLAB Indonesia, several medical devices made from animal materials are used in the human body, including surgical sutures, artificial heart valves, cardiac catheters, vascular graft prosthetics, vascular hemostatic devices, and bone grafts. Furthermore, some products come into direct contact with the body, such as wound dressings, and others contain alcohol, such as alcohol swabs. 

Mulyorini provided an interesting example of a seemingly simple medical device that could raise halal issues. She explained, “There’s a possibility that plastic tubing uses a plasticizer made from fat. The question is, where does that fat come from? If it’s from an animal, it must be clear which animal. Of course, if it’s from a pig, it cannot be certified halal.” 

As is well known, animal materials can have many derivatives. These include fats that can be used as ingredients in tallow (animal fat derived from cows, goats, or sheep), shortening (white butter), chicken fat, and processed derivatives such as glycerin (E422), fatty acids and their derivatives, fatty acid salts or esters, and additives like magnesium stearate. All of these have the potential to be used in medical devices, so their sources must be clearly identified. 

Mandatory Halal Regulations 

The legal basis for halal certification is strengthened through Government Regulation (PP) Number 42 of 2024, which requires all products circulating in Indonesia to be halal-certified, including medical devices. Implementation will be phased in, starting in 2026 for Class A medical devices, moving to Class B in 2029, Class C in 2034, and Class D and biological products in 2039. This provision obliges the industry to register its products for halal certification from the BPJPH (Indonesian Food and Drug Authority) as proof of regulatory compliance and consumer protection. 

To help the industry prepare, LPPOM has launched halal certification services for medical devices. One such program is the Halal On 30 program, accessible through bit.ly/HalalOn30. This program is designed to facilitate business actors in understanding the BPJPH halal certification process in just 30 minutes. 

This technical strengthening activity demonstrates that halal certification for medical devices is not merely about complying with regulations, but also about ensuring consumer protection, encompassing both safety and confidence. With awareness of the critical points of halal certification and industry support to meet them, it is hoped that medical devices distributed in Indonesia will be truly guaranteed to be halal, safe, and beneficial to the broader community. (YN)