On January 2023, the President issued a Presidential Decree No. 6/2023 concerning Halal Certification for Drugs, Biological Products and Medical Devices which is based on Government Regulation No 39/2021 concerning Halal Product Implementation.
Compared to the previous halal regulation, this decree specifically regulates halal implementation on drugs, biological products, and medical devices while the basis regulation is broader compared to the decree. In the halal product implementation, all medical devices which originated from animals and/or contained animal derivatives circulating in Indonesia must be halal certified.
Halal Requirements
Medical devices must adhere to the halal requirements for both the production process and the materials in order to receive Halal certificates.
Materials in this case covers the following:
a. Raw materials including active substances and additives.
b. Packaging, lubricants, grease, or sanitizers that come in direct contact with materials or products.
c. Purification aids in direct contact with production facilities to produce products.
d. Media for validating purification results of facilities that have direct contact with materials or products.
The above “materials” refer to materials that come from animals, plants, microbes, materials produced through chemical processes, biological processes or genetical engineering processes. It’s also stipulated in the regulation that alcohol/ethanol materials are allowed as long as it does not originate from khamar (liquor) industries.
While the halal manufacturing process is part of the Halal Product Process (from Government Regulation No. 39/2021), which includes the provision of materials, processing, storage, and packaging.
Non-Halal Information Labelling
Medical devices that contain haram materials can still be sold in Indonesia as long as the Non-Halal Information/Statement written in the device’s labelling requirements are met. These requirements include specific labeling requirements for non-halal materials and non-halal manufacturing processes, as follows:
● For non-halal materials, the non-halal labelling must specify the haram materials with different colors than the rest of the composition materials written in the device’s labelling.
● For non-halal manufacturing processes but composed from halal materials, the non-halal labelling must have the information/statement indicating “Halal materials and in an effort to comply with the halal process” in the labelling.
Enforcement Timeline
Previously, the Government Regulation No. 39/2021 only specified the enforcement timeline for medical devices up to risk Class C. With the issuance of the new Presidential Decree No. 6/2023, the enforcement timeline has been extended to include risk class D medical devices. The specific due dates for each risk class can be found in the table below:
|
Risk Class |
Due Date of Enforcement |
|
A |
17th October 2026 |
|
B |
17th October 2029 |
|
C |
17th October 2034 |
|
D |
17th October 2039 |
As a result of this decree, it is anticipated that the related ministry such as the Mistry of Health and the Ministry of Religious Affairs will issue further regulations or guidance related to the implementation of the halal requirements for medical devices in the future.