The Halal Product Assurance Organizing Agency (BPJPH) has prepared draft guidelines on the implementation of the Halal Product Assurance System for medical devices and household health products.
The draft provides proposed criteria for determining which medical devices would be subject to halal certification, together with requirements relating to materials, halal product processes, products, monitoring, and evaluation under the Halal Product Assurance System (Sistem Jaminan Produk Halal or SJPH).
As the guideline remains in draft form, the requirements have not yet been officially implemented.
Read the draft guideline here: Draft Guidelines for the Implementation of the Halal Product Assurance System for Medical Devices and Household Health Product [PDF] in Indonesian. English translation is currently not available.
Purpose of the Draft Guideline
To provide proposed guidance on the implementation of halal certification requirements for medical devices and household health products in Indonesia.
The draft also outlines the proposed SJPH requirements applicable to affected products and provides criteria for determining whether a medical device would be subject to halal certification.
Scope of Halal Certification for Medical Devices
According to Chapter II, Section A, point d of the draft guideline, medical devices required to obtain halal certification must meet the following criteria:
- The medical device is derived from animals, contains animal elements, and/or contains alcohol; and
- The medical device enters the human body and/or comes into direct contact with human body parts.
These criteria apply only to medical devices used in connection with ritual worship that requires purity from impurities and uncleanness.
Medical devices that do not meet these criteria would be exempt from the halal certification requirement.
According to the draft, for exempt medical devices, there would be no requirement to assess materials and processes, apply halal-related labels, or submit related reports.
Products Using Non-Halal or Unverified Materials
Medical devices that meet the criteria for halal certification but are manufactured using:
- Haram materials
- Materials whose halal status has not yet been established
- Processes that do not comply with halal requirements
May still be distributed and traded, provided that they bear a “Not Halal” label in accordance with the applicable regulations.
For products originating from overseas, the “Not Halal” label may be affixed after the product arrives at the warehouse of the License Holder in Indonesia.
Key SJPH Requirements
1. Commitment and Responsibility from Business Actors
Business actors are expected to establish and maintain the required commitment and responsibilities for implementing the Halal Product Assurance System.
2. Materials
Materials used to manufacture medical devices and household health products may originate from animals, plants, microbes, or materials produced through chemical, biological, or genetic engineering processes.
Under the draft SJPH requirements, halal materials may include:
- Materials supported by a halal certificate or registered foreign halal certificate.
- Materials exempt from halal certification requirements.
- Materials not yet included under the applicable product or material regulations, provided they are either halal-certified or included in the list of materials exempt from halal certification.
Where applicable, supporting documentation may include:
- Production process flow
- Product composition
- Certificate of Analysis (CoA)
- Statements confirming that the material is free from impurities
- Halal questionnaires
- Material Safety Data Sheets (MSDS)
- Other documents whose authenticity can be verified by the Business Actor
Materials should also be produced while the relevant Halal Certificate remains valid.
3. Halal Product Process
The draft requires the Halal Product Process to include:
- Separation of premises and equipment from those used for processing non-halal products.
- Written and documented procedures.
4. Product Requirements
Under the proposed requirements:
- Products must be made from halal ingredients and processed in accordance with SJPH requirements.
- Premises, equipment, devices, production facilities, processing systems, packaging, and storage must not be contaminated with non-halal materials.
- Product names must not refer to prohibited or haram substances.
- Products must not contain pornographic elements or characteristics that indicate prohibited products or products declared haram under applicable halal fatwa rulings.
- Business operators must produce products or materials that are safe to use.
5. Monitoring and Evaluation
Business actors must conduct monitoring and evaluation in accordance with SJPH requirements.
Decision Tree for Medical Devices Subject to Halal Certification
The draft guideline includes a decision tree for determining whether a medical device would be subject to halal certification.
Please refer to Page 21 of the draft guideline.
This section is provided in Indonesian only, and no English translation is currently available.
Class A Medical Devices
Medical devices under Class A that are anticipated to require full implementation of halal certification are listed on Pages 22–25 of the draft guideline.
Manufacturers should note that these provisions remain in draft form and should not yet be treated as final requirements.
Implications to Clients
At this stage, no action is required from manufacturers, as the guideline remains in draft form and has not yet been officially issued or implemented by the relevant authority.
According to Page 3 of the draft guideline, the proposed requirements are expected to take effect three months after the regulation or guideline is officially issued.
Manufacturers should therefore continue to monitor developments, particularly if their products:
- Contain animal-derived materials or alcohol.
- Enter or directly contact the human body.
- Fall within the Class A product categories identified in the draft.
- May require halal certification or “Not Halal” labeling under the proposed framework.
No changes to existing product documentation, labeling, manufacturing processes, or halal certification activities should be made solely on the basis of this draft until the final requirements are officially issued.
Andaman Medical will continue to monitor the implementation of the halal certification requirements and provide further guidance on the applicable processes and required actions following official issuance.
Proposed Effective Date
The guideline has not yet been officially issued.
According to the current draft, the requirements are proposed to take effect three months after the regulation or guideline is officially issued.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Indonesia, please contact sales@andamanmed.com.