ILHAM HIDAYATTULAH

“Distributors with existing IPAK licenses will need to show compliance to CDAKB upon renewal. Manufacturers should confirm with their distributors that they are in compliance by the time their IPAK license is set to expire.”

Ilham Hidayattulah
Principal Consultant
Asia Actual Indonesia

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Good Distribution Practice Requirements (CDAKB) in Indonesia

Published on: October 28th, 2022

New Requirements Put in Place in 2020

In 2014, the Indonesian Ministry of Health introduced the Good Method of Distribution of Medical Devices (or CDAKB) in order to enforce good distribution practice requirements in the country. The CDAKB is a series of guidelines put in place to standardize quality control across the Indonesian medical device market. The regulation has had a long period of implementation, only becoming mandatory in 2020, six years after its introduction. 

CDAKB was put in place to regulate quality control across medical devices distributed in Indonesian markets. It affects all major aspects of distribution, including handling of products and record keeping. The CDAKB makes it so that in the event of a product recall there is a clear pipeline of access to the distributors/manufacturer in order to ensure complete user safety. This brings local alignment with similar distributor requirements in the region like GDPMDS in Singapore. If you are looking for more specific information on CDAKB compliance please contact us here. 

The following are requirements of CDAKB and are utilized to promote good distribution practice in Indonesia: 

  1. Quality management system
  2. Resource management
  3. Building and facilities 
  4. Storage and inventory handling 
  5. Product traceability  
  6. Complaint handling 
  7. Field safety corrective action 
  8. Return system 
  9. Destruction system 
  10. Illegal and unqualified medical devices recording 
  11. Internal audit 
  12. Management review 
  13. 3rd party / Outsourcing activity 

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.  

Come Grow with Us 

Asia Actual has an office in Indonesia staffed by experienced, bilingual regulatory and commercial professionals to address any questions or provide support. Please contact us to explore if this new program is appropriate for your devices. 

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services. 

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