CDAKB (Medical Devices Good Distribution Practice)

Why is Medical Device Distribution Important?

The availability of medical devices is crucial for public health and the healthcare system. These devices not only support disease prevention but also play a vital role in diagnosis, treatment, and patient care. To maintain a reliable supply chain, the distribution of medical devices must follow proper standards to ensure quality and safety. In Indonesia, the distribution process is regulated under the Cara Distribusi Alat Kesehatan yang Baik (CDAKB), or Good Distribution Practices for Medical Devices (GDP-MD).

CDAKB refers to the regulatory framework that governs the proper distribution of medical devices in Indonesia. It ensures that medical devices maintain their safety, quality, and effectiveness throughout the supply chain. According to Minister of Health Regulation No. 4 of 2014, all medical device distributors and their branches must comply with these standards to operate legally.

CDAKB outlines specific requirements for medical device distributors, including:

• Quality Management System: Implementing procedures to manage the acceptance, storage, distribution, and sale of medical devices.
• Resource Management: Ensuring sufficient personnel and resources for compliant operations.
• Buildings and Facilities: Maintaining appropriate facilities for safe storage and handling.
• Inventory Control: Implementing systems for proper tracking and storage of medical devices.
• Product Traceability: Ensuring the ability to track devices by maintaining records of manufacturers, serial numbers, customer data, and authorization numbers.
• Complaint Management: Establishing a system to handle and resolve customer complaints effectively.
• Field Safety Corrective Action (FSCA): Implementing procedures to address safety issues or recalls.
• Return and Disposal Systems: Managing returns and the safe disposal of medical devices.
• Illegal and Non-Compliant Devices: Identifying and managing non-conforming or unauthorized products.
• Internal Audits and Management Reviews: Conducting regular internal reviews to ensure continuous compliance.
• Third-Party Oversight: Monitoring and controlling outsourced activities to ensure regulatory adherence.

CDAKB certification is mandatory for all medical device distributors in Indonesia. It not only ensures compliance with national regulations but also provides several benefits, including:

1. Ensuring Patient Safety: Certified distributors maintain high-quality standards, ensuring safe and effective medical devices.
2. Market Access: CDAKB certification is required for listing medical devices in Indonesia’s sectoral e-Catalogue.
3. Regulatory Compliance: It helps companies comply with Government Regulation No. 28 of 2024, minimizing legal risks and protecting their reputation.
4. Operational Efficiency: Implementing CDAKB standards improves inventory management, quality control, and overall efficiency.

Recent Updates: Mandatory CDAKB Certification for e-Catalogue

As per Circular Letter No. HK.02.02/E/1753/2024, the Indonesian Ministry of Health mandates that all medical device distributors must obtain CDAKB certification to list their products in the e-Catalogue system starting January 1, 2025. This update emphasizes the government’s commitment to maintaining high standards for medical device distribution.

Steps to Obtain CDAKB Certification

1. Application Submission: Submit the CDAKB application through the Online Single Submission (OSS) system.
2. Document Verification: The Ministry of Health reviews and verifies the application documents.
3. On-Site Audit: If documents meet the criteria, an on-site audit is scheduled at the distribution facility.
4. Corrective Actions (CAPA): Any non-conformities identified during the audit must be addressed and resubmitted.
5. Certification Issuance: Once all corrective actions are verified, the CDAKB certificate is issued.

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Navigating the CDAKB certification process can be complex, but INSIGHTOF simplifies it with expert guidance and efficient service. Our team provides comprehensive support, ensuring your business meets all regulatory requirements quickly and effectively.

Why Choose INSIGHTOF?

• Regulatory Expertise: Deep knowledge of Indonesian medical device regulations.
• Efficient Processes: Streamlined certification assistance to save you time and resources.
• Local Connections: Strong relationships with regulatory authorities for smoother approvals.
• Tailored Support: Personalized services to meet your specific business needs.

Ensure your medical device distribution complies with Indonesia’s regulatory standards. Contact INSIGHTOF today for expert assistance in obtaining your CDAKB certification.

For any inquiries, please feel free to contact us at marketing@insightof.co.id.