Maintaining Halal Compliance is one of the most important post-market responsibilities for foreign medical device manufacturers entering Indonesia. While obtaining a Halal certificate is a major milestone, the real work begins after approval.
Indonesia’s Halal Product Assurance Law requires manufacturers to ensure the ongoing integrity of materials, production processes, and distribution—long after the certificate has been issued.
Medical device companies that fail to maintain Halal compliance may face certificate suspension, distribution barriers, tender disqualification, and reputational risk.
Why Post-Market Halal Compliance Matters
Medical devices containing biological, animal-derived, or mixed-material components fall under Halal regulation. Even fully synthetic devices require monitoring to ensure no changes occur in upstream sourcing or downstream handling.
Post-market compliance matters because:
- Halal is a continuous obligation, not a single approval
- MoH (Regalkes) renewal depends on a valid Halal status
- Hospitals, distributors, and e-Katalog require continuous compliance
- BPJPH can conduct surveillance without prior notice
- Any change in materials or the supply chain must be reported
In short, Halal certification is not the finish line—it is the starting point.
Indonesia’s Regulatory Expectations After Certification
BPJPH requires manufacturers and local representatives to maintain:
- SJPH (Halal Assurance System) implementation
- Annual monitoring by BPJPH or LPH
- Incident and change reporting (materials, suppliers, facilities)
- Label consistency in MoH Regalkes
- Distribution compliance with IDAK and CDAKB requirements
Even small changes, like switching adhesive suppliers or updating a packaging material, must be evaluated for Halal impact.
Foreign manufacturers often struggle with post-market Halal obligations because they sit at the intersection of supply chain management, audit preparedness, regulatory updates, distributor coordination, and documentation control.
This is where Product Registration Indonesia becomes your strategic partner by supporting manufacturers across the entire 4-year certificate lifecycle.
1. Continuous Halal Compliance Monitoring
- Tracking supplier changes
- Assessing new materials for Halal risk
- Ensuring updated SJPH documentation
- Verifying Halal logo use and label consistency
- Monitoring distributor licenses (IDAK, CDAKB)
2. Surveillance & Audit Support
BPJPH/LPH audits may occur annually or based on risk signals. Product Registration Indonesia assists with pre-audit checks, preparing evidence, declarations, and traceability files. We also support corrective action responses by communicating with auditors on your behalf.
3. Renewal Planning to Avoid Market Delays
Halal certificates expire every 4 years. Product Registration Indonesia manages renewal timeline tracking and avoiding disruptions that could block tenders or procurement.
To guide medical device manufacturers in preparing their Halal Certification process in Indonesia, Product Registration Indonesia provides a comprehensive guideline.
Maintaining Halal Compliance Ensures Long-Term Market Access
Maintaining Halal Compliance is not optional—it is a continuous responsibility that determines renewal, regulatory acceptance, distribution stability, and brand trust in Indonesia’s rapidly growing medical device market.
With Product Registration Indonesia as your partner, foreign manufacturers gain structured, proactive, and audit-ready compliance management that keeps products legal, competitive, and protected.
