The implications of the halal certification process for medical devices incorporating animal products in Indonesia
Catering to Indonesia’s growing need for halal products
Indonesia accounts for the largest Muslim population worldwide. With approximately 225 million Muslims, there is an increasing demand for Halal products. In response to this growing need, the Government aims to establish Halal certification for all products circulating in Indonesia.
As part of the undertaking, the Indonesian Government issued Regulation No. 33 dated 17 October 2014, also known as the Halal Law 2014, concerning the Halal Products Guarantee. Subsequently, as of October 2019, all imported, distributed, and traded products in Indonesia, including medical devices, are subject to Indonesia’s certification process and labeling requirements. The halal certification process establishes if a product adheres to the Islamic law,” halal,” or if they contain pork or deviate from the Islamic law, “haram.” The Halal Product Guarantee Agency or Badan Penyelenggara Jaminan Produk Halal (BPJPH), oversees all halal certification processes.
The Halal Inspection Agency or Lembaga Pemeriksa Halal (LPH) conducts inspection and Halal Product Testing. The role of the Indonesia Ulema Council or Majelis Ulama Indonesia (MUI) is issuing fatwas (legal decisions) in the certification process.
The recently issued GR 39/2021 regulation and what it means for medical devices
As Indonesia continues to depend on imported medical devices to support its healthcare sector, halal product guarantees for medical devices utilizing animal products are needed. The Indonesian Government recently issued the GR 39/2021 regulation entitled “Implementation of Halal Product Guarantee” to ensure medical device manufacturers’ compliance.
At present, halal certification for medical devices is voluntary. However, according to Article 141 of the newly implemented GR 39/2021 regulation, it will be mandatory for medical devices containing Animal Derived Materials (ADMs) to register for Halal certification according to the following schedule. The validity period of halal certification is four years.
Mandatory dates for Indonesia’s halal certification according to the four risk classes:
Risk Criteria | Device Class | Mandatory dates for halal certification and labeling requirements |
Low Risk | A | 17 October 2026 |
Low Moderate Risk | B | 17 October 2029 |
Moderate-High Risk | C | 17 October 2034 |
High Risk | D | set in President Regulation |
To date, numerous imported medical devices incorporate a range of materials, containing animal tissues and other materials of animal origin, into the finished product. These ADMs are common and primarily used in polymers to stabilize formulations or manufacture medical device components such as coatings, tubing, connectors, and packaging.
ADMs may also constitute a significant portion of a finished device, such as bovine heart valves, bone substitutes, and collagen injection. What’s more, commonly used fibers and resins in the medical industry, PVC, PP, PVC, Acetal, TPU, TPV, and PE, may also contain ADMs. Forestomach, gelatine, collagen, tallow, wool, fat, bone, heart valves, pericardium, chondroitin sulfate, sub-intestinal mucosa, pericardium chitosan, and hyaluronic acid are animal origin technology that is currently in use for various clinical applications.
Although animal materials can provide therapeutic and biocompatibility advantages over non-animal materials, their use in medical devices is a cause of growing concern for the Muslim population.
The implications for medical devices containing ADM
Obligations for halal certification for medical devices containing ADM have been in place since October 2019. During the various transition periods, medical devices that are yet to be halal certified may circulate in Indonesia without specific labeling. However, once the respective transition period has passed, all products in that risk class must adhere to halal certification requirements, including labeling, stating if the medical device containing ADM has passed halal certification (halal) or not (non-halal).
Special consideration
In an event where the medical device did not pass the halal certification but is the only standard of care for treatment, the medical device is permitted to circulate in the market but with special labeling. GR 39/2021 Article 93 states that companies must utilize different colors to present the ingredients’ composition. Also, companies must highlight their haram ingredients in red, as per the regulations in Indonesia’s Halal Law (GR 33/2014) and Indonesia’s Halal Certification 2019 regulations (GR 31/2019).
Indonesia Halal Certification: the procedure
According to the new regulation no. GR 39/2021, Indonesia’s halal certification is as follows:
- Stage 1: Determination of halal product status
- Performed by the MUI delegation through the MUI halal fatwa session (refer to Article 76 paragraph 1)
- Stage 2: Submission of the decision on halal certification to the BPJPH
- Results are presented within 3 (three) days after the MUI receives the documents’ inspection results from the LPH (refer to Article 77 paragraph 1)
- Stage 3: Product label designation by the BPJPH (Halal or non-halal)
- Halal product certification: the BPJPH issues a Halal Certificate within not more than 1 (one) day (refer to Article 78 paragraph 2)
- Non-halal product designation: the BPJPH issues a non-halal letter of statement within 1 (one) day.
What manufacturers or distributors must know when applying for a halal certificate in Indonesia
- The BPJPH may request a halal certificate from manufacturers, importers, or distributors.
- Foreign manufacturers intending to supply medical devices containing ADM in Indonesia must obtain halal certification from an agency in their own country. The BPJPH must license this agency.
- There is no need for individual halal certificates for each raw material used in the medical device, but the medical device must comply with halal requirements.
How Andaman Medical can help
At present, only manufacturers are eligible to apply for halal certification online. If you are uncertain about the halal certification process or halal certification criteria and require further clarification regarding the need to get your product halal-certified, please contact us.
Andaman Medical has the in-house expertise to help foreign manufacturers import their animal-derived medical devices into Indonesia. We can provide a Regulatory Intelligence Report regarding the process and documents required for Halal certification to facilitate the application process.
