Do you know what CDAKB is? Let's dig into what CDAKB is.

CDAKB is (Cara Distribusi Alat Kesehatan yang Baik), which serves as the implementation of the Health Law Number 36/2009, articles 96 and 107, regarding pharmaceutical preparations and medical devices. The purpose of CDAKB is to ensure that medical devices, in-vitro diagnostics, and household health supplies are guaranteed, maintaining their safety, quality, and intended benefits.

CDAKB certification is granted to medical device and in-vitro diagnostics distributors who meet the standards for product distribution, handling, and storage. This certification is issued by the Indonesian Ministry of Health. Every distributor of medical devices (Ijin Distribusi Alat Kesehatan-IDAK) in Indonesia is required to comply with the Ministerial Regulation Number 4/2014 concerning Good Distribution Practices for Medical Devices.

Medical device distributors with an existing license as IPAK (License for Health Device Distributor) are required to migrate their permits to IDAK (Medical Device Distribution License). Subsequently, during the CDAKB certification process, the distributor company will be audited and evaluated by an audit team covering 13 aspects, including:

1. Quality Management System

2. Human resources

3. Buildings and facilities

4. Inventory storage and handling

5. Overall evaluation

6. Customer complaints

7. Field safety corrective action

8. Returns

9. Destruction of damaged goods

10. Illegal or non-compliant products

11. Internal audits

12. Management review

13. Third-party activities

The audit team will evaluate the quality of the distributor's management system, including hygiene, handling of medical devices, receiving and storing medical devices, and product delivery. After successfully passing the evaluation process, the medical device distributor, in-vitro diagnostics, and household health supplies will be awarded the CDAKB certificate by the Ministry of Health, represented by the Director-General of Pharmaceuticals and Medical Devices – Directorate of Medical Device Surveillance. This certificate indicates that the distributor has met the standards set by the Ministry of Health. The certification instills consumer confidence that the distributed medical devices have undergone appropriate and safe processes. Distribution Companies for Medical Devices in Indonesia.

Source: Ditwaskes

In the context of the industry, when you are a business player involved in the distribution of medical devices, in-vitro diagnostics, and household health supplies in Indonesia, obtaining CDAKB certification is mandatory and crucial. This certification ensures the quality and safety of your products and contributes to the sustainability of your business. Currently, for registering imported medical devices (AKL registration), distributors must possess the CDAKB certificate. This requirement aims to enhance the quality of the medical device and in-vitro diagnostics industry in Indonesia, ultimately improving the level of safety in providing healthcare services to the public.

PT INSPIRY INDONESIA KONSULTAN is here to assist you, entrepreneurs in the distribution of in-vitro diagnostics, medical devices, and household health supplies. We serve as a reliable partner in providing services to facilitate the CDAKB certification process. Our assistance includes:

1. Preparation of legal documents

2. Preparation of 48-50 Standard Operating Procedures

3. Work assistance socialization

4. Internal audit socialization

5. Internal audit assistance

6. Open-Closing CAPA

7. Submission to OSS (Online Single Submission)

8. External audit

9. Open-Closing CAPA for external audit

10. Issuance of the CDAKB certificate

With our experience, dedication, and commitment, we are ready to help your company achieve the CDAKB certification. Together, let's collaborate to strengthen the medical device industry and drive Indonesia's economic growth.