Indonesia Halal Certification for Medical Devices under Perpres No. 6/2023

Indonesia has introduced Halal certification requirements for medical devices through Peraturan Presiden No. 6 Tahun 2023, which governs halal certification for drugs, biological products, and medical devices.

Under this regulation, medical devices that originate from or contain animal-derived materials must obtain a Halal certificate before they can be marketed in Indonesia. Certification is issued by the Halal Product Assurance Organizing Body (BPJPH) under the Ministry of Religious Affairs.

Products already certified by a Foreign Halal Certification Body (LHLN) with a Mutual Recognition Agreement (MRA) with BPJPH do not require a new certification, but the existing certificate must be registered with BPJPH before marketing.

Scope of Halal Certification

• Who is affected: All medical devices, drugs, and biological products containing animal-derived materials.

• Responsible authority: Badan Penyelenggara Jaminan Produk Halal (BPJPH) under the Ministry of Religious Affairs.

• Foreign certification recognition: Certificates from recognized foreign bodies (LHLN) with an MRA with BPJPH are accepted, provided they are registered in Indonesia.

Devices without animal-derived materials are currently exempt, but any non-Halal ingredients must be labeled accordingly.

Implementation Phased by Risk Class

The phased implementation allows manufacturers to plan certification processes according to the risk class of their products.

Compliance Steps for Manufacturers

1. Identify products containing animal-derived or prohibited materials.

2. Apply for Halal certification with BPJPH for domestic certification.

3. Register existing foreign Halal certificates if the certifying body has an MRA.

4. Update product labeling to indicate non-Halal ingredients, where applicable.

5. Plan compliance according to risk-class phased deadlines.

Early planning ensures smooth entry into the Indonesian market and avoids potential regulatory sanctions.

Regulatory and Market Impact

• Enhanced consumer assurance: Ensures that animal-derived medical devices meet Indonesia’s Halal standards.

• Market access requirements: Halal certification becomes a prerequisite for market entry for affected products.

• Global harmonization: Mutual Recognition Agreements allow some foreign certifications to be recognized, reducing duplication.

• Labeling transparency: Non-Halal materials must be declared clearly to comply with the regulation.

References and Official Sources

• Peraturan Presiden No. 6 Tahun 2023 (Official Presidential Regulation)

Internal References

• MOH Indonesia Medical Device Registration

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