What is CDAKB?
In Indonesia, Good Distribution Practices for Medical Devices, known as Cara Distribusi Alat Kesehatan yang Baik (CDAKB), establish standards for the distribution and quality control of medical devices. These guidelines ensure that medical devices meet the required standards for their intended use, maintaining their quality, safety, and effectiveness throughout the distribution process.
CDAKB certification focuses on implementing Standard Operating Procedures (SOPs) within medical device distribution companies to ensure compliance with regulatory standards. This certification guarantees that distributed products meet the required standards, preventing substandard and counterfeit devices from entering the supply chain. According to Indonesia’s Minister of Health Regulation No. 4 of 2014, all medical device distributors must implement CDAKB. Moreover, Government Regulation No. 5 of 2021 mandates that medical device distributors must obtain a CDAKB certificate as part of their licensing requirements.
Why is CDAKB Certification Important?
Obtaining CDAKB certification offers several key benefits, such as:
- Ensuring the quality, safety, and efficacy of medical devices distributed to the public.
- Increasing consumer confidence in the medical devices available in the market.
- Helps companies comply with regulations and improve efficiency
- CDAKB certification helps companies comply with the government’s regulatory requirements, minimizing the risk of penalties and protecting the company’s reputation.
Requirements for CDAKB Certification
According to Ministry of Health Regulation No. 4 of 2014, the requirements for obtaining CDAKB certification are as follows:
- Must have a quality management system
- There must be evidence of resource management related to personnel
- Have buildings and facilities that comply with good medical device distribution practices
- Have a good storage and inventory handling system
- Able to trace products
- Handle customer complaints
- Handle field safety corrective actions (FSCA)
- Have a system for returning medical devices
- Have a mechanism for the disposal of medical devices
- Identify illegal medical devices and those that do not meet requirements
- Internal audit
- Management review
- Evidence of third-party activity control (outsourcing activities)
Steps to Obtain CDAKB Certification
To obtain CDAKB certification, follow these steps:
- Applicant submits CDAKB Certificate application for Medical Device Distribution via the OSS system
- Complete the requirements through Online Single Submission (OSS) System
- Officer receives application document files and verifies them. If the requirements are not yet complete, the officer provides notes on things that must be completed and corrected through OSS System.
- For documents that have met the requirements, a schedule is made and On Site Audit is carried out at Medical Device Distribution facilities.
- Audit results are submitted in an official report.
- Corrective Active Preventive Action (CAPA) are addressed and submitted via OSS.
- Officers assess the CAPA submitted through the OSS system to ensure that the requirements are met.
- CDAKB Certificate is issued once CAPA is verified and all requirements are met.
How InsightOf Can Help?
Need help with CDAKB certification for your medical device distribution? InsightOf makes the process fast and easy. With our expertise and local connections, we ensure quick, cost-effective certification and smooth market access. Contact us today!
Insightof Advantages:
- Expert guidance on regulatory compliance for CDAKB certification.
- Fast and efficient service, saving you time and costs.
- Strong local contacts for smoother market access.
- Tailored support to navigate complex regulatory processes.
- Proven experience with medical device distribution requirements.
Sources:
Ministry of Health Regulation No. 4 of 2014
Module of CDAKB
https://drive.google.com/file/d/1RZRgWxPfBcEdlBzkwKiBkoNDZu9lwYTM/view
Handbook Self-Assessment CDAKB
