Good Distribution Practice Requirements (CDAKB) in Indonesia

CDAKB Compliance Required for New and Renewing IPAK Licenses 

There is no set implementation date for the CDAKB guidelines, however, a certificate of CDAKB compliance is now required to receive an IPAK certificate, the Indonesian medical device distribution license which retains its validity for five years. In order to renew their IPAK certificate, or recieve a new one, Indonesian distributors must be CDAKB compliant, making it imperative for medical device distributors in the region to follow the guidelines set forth by the Ministry of Health. More information on Indonesia License Holding and Indonesia Medical Device Registration can be found on the Asia Actual website.  

Requirements are similar to those found in ISO 13485, whose specifications can be found here. Manufacturers will want to check with their distributors to ensure they meet the qualifications set forth in this notice.  

The CDAKB Requirements for distributors are detailed below. Indonesian distributors looking to be IPAK certified must submit evidence of the following:  

1. Company Data, including valid IPAK (if renewing), medical device approval, and more.  
2. Technical person of responsibility on staff.  
3. Management representative on staff for licensing procedures, and more.  
4. Distribution quality control procedures.  
5. Hygiene, pest control, safety quality procedures.  
6. Human resources procedures, including employee recruitment and training.  
7. Marketing, including customer satisfaction, complaint and quality procedures.  
8. Purchasing procedures, including supplier selection and evaluation.  
9. Storage capabilities.  
10. Maintenance and repair procedures.