CPB Certificate (Good Manufacturing Practice) for Medical Devices
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What Is a CPB Certificate for Medical Devices?
The The CPB Certificate (Good Manufacturing Practice for Medical Devices) is an official certification granted to medical device manufacturers that have complied with government standards for production quality systems and quality control.
CPB memastikan bahwa alat kesehatan yang diproduksi:
✅ aman digunakan
✅ memenuhi standar mutu
✅ sesuai tujuan penggunaan medis
Sertifikat CPB merupakan persyaratan wajib untuk kegiatan produksi alat kesehatan di Indonesia.
➡ CPB is the updated regulatory framework replacing the previous system (CPAKB).
Legal Basis for the CPB Certificate for Medical Devices
Medical device manufacturing regulations now refer to:
- Minister of Health Regulation No. 11 of 2025 on Business Activity Standards and Product Standards under Risk-Based Business Licensing in the Health Subsector
- Risk-Based Business Licensing System (OSS-RBA)
Under the latest regulation:
✅ Produsen wajib menerapkan CPB untuk memperoleh Persetujuan Berusaha untuk Menunjang Kegiatan Usaha (PB UMKU)
✅ Sertifikat CPB diberikan setelah verifikasi dokumen dan/atau verifikasi lapangan
✅ Sertifikat menjadi bukti pemenuhan standar produksi alat kesehatan
Benefits of Holding a CPB Certificate for Medical Devices
- Primary requirement to obtain medical device distribution authorization
- Official legal status for manufacturing activities
- Enhances trust from distributors and buyers
- Required for participation in government tenders and export activities
- Evidence of an implemented production quality management system
Latest Provisions for CPB Certification for Medical Devices (Regulatory Update 2026)
The following are the key adjustments in the medical device manufacturing certification mechanism:
- Change in nomenclature from CPAKB to CPB for Medical Devices
The production certification system has been updated in accordance with the latest standards issued by the Ministry of Health of the Republic of Indonesia. - Quality system principles remain based on Good Manufacturing Practice
The focus remains on production process control, product quality, and user safety. - The CPB Certificate serves as compliance with standards for Risk-Based Business Licensing (PB UMKU)
Certification forms part of the mandatory fulfillment of business activity standards in the health sector. - Verification is conducted through document evaluation and/or on-site inspection
The verification method is determined based on risk level and the readiness of the production facility. - Corrective Action and Preventive Action (CAPA) mechanism is provided (maximum 30 days)
If requirements are not met, the company must implement corrective actions based on audit findings. - Applications are processed after all requirements are complete and PNBP fees have been paid
These provisions refer to business activity standards for the health subsector under Minister of Health Regulation No. 11 of 2025.
Early preparation of documentation, quality systems, and production facilities is essential to ensure a smooth certification process.
Why Choose Us?
- Extensive experience assisting Alkes and PKRT manufacturers
- Full support for SOP development and factory layout review
- Fast, transparent process in full compliance with regulations
FAQ – Frequently Asked Questions
- Can a new company apply for the CPAKB Certificate?
Yes. New companies can apply as long as they have a compliant production facility, valid legal documents, and qualified technical personnel. - What if we don’t have technical staff yet?
We can help you find or recommend qualified personnel that meet regulatory standards. - Can PT Multi Jasa Berjaya help with SOP preparation?
Yes, we offer end-to-end services including SOP preparation and implementation assistance. - Is it mandatory to own a production facility?
Ideally, yes. Your facility must meet CPAKB standards and will be subject to audit by the Ministry of Health. Third-party facilities may be accepted if formal agreements and compliance can be demonstrated. - Can the process be done without traveling to Jakarta?
Yes. Most of the process can be conducted online. However, a site audit by the Ministry of Health will still be carried out at your company’s distribution facility. - How do I start the process with PT Multi Jasa Berjaya?
You can contact us via WhatsApp or the contact form on our website. We'll schedule a consultation session to assess your company’s readiness and explain the entire process in detail. - How much does the CPAKB service cost?
Fees depend on your company’s condition and readiness. Please contact our team for the best offer and free consultation.
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