1.      The Good Distribution Practice for Medical Devices (CDAKB) is a guideline for the distribution activities and quality assurance of medical devices. The concept of CDAKB is equivalent to ISO.

2.      The purpose of obtaining CDAKB certification is to guide medical device distributors to carry out distribution activities—such as ordering, storage, transportation, and other related aspects—in accordance with the Ministry of Health’s standards based on Good Distribution Practice (GDP).

3.      In the process of obtaining a distribution license for medical device products, a medical company or medical branch company must first obtain IDAK certification, then CDAKB certification, and only afterward can they apply for AKL/AKD certification.

4.      Currently, obtaining CDAKB certification is not mandatory. However, according to Ministry of Health Regulation No. 4 of 2014 and Government Regulation No. 5 of 2021, in the future, every medical company or medical branch company that holds an IDAK certification and intends to apply for AKL/AKD certification will be required to obtain CDAKB certification.

5.      The CDAKB certification process involves audits of documentation, buildings (including offices and warehouses), and human resources.

6.      All information on the CDAKB certificate is based on the information from the IDAK certificate, including the registered categories of medical devices.

7.      The main requirements for applying for CDAKB certification are as follows:

–        The business scope includes 46691

–        Have an active OSS RBA account.

–        Hold a valid IDAK certificate.

–        Own buildings and facilities that comply with CDAKB standards.

–        Have ISO 9001 / ISO 13485 certification for medical device distribution scope (if available).

–        The Technical Person in Charge (PJT) must be employed full-time and hold a CDAKB training certificate.

8.      The CDAKB certificate is valid for 5 years and can be renewed.