Understanding the CDAKB Certification Process

The Certificate of Good Medical Device Distribution Practices (CDAKB) is important to prevent the entry of substandard and counterfeit medical devices into the medical device supply chain in the community. In order to support the acceleration of safe business licensing from Law No. 11 of 2020 concerning Job Creation, since mid-2022, several changes have been made to the CDAKB certification process, one of which is self-assessment. The purpose of the self-assessment is for companies to be able to conduct an independent initial assessment of the implementation of CDAKB. To access the self-assessment facility and other certification processes, users must first register an account on the Online Single Submission (OSS) system.

CDAKB Certification Application Process:

1. Account Registration: Business actors must be registered in the OSS RBA system and have a standard certificate or a distribution permit for medical devices
2. Login and Form Filling: Log into the OSS RBA system, select the PB UMKU menu corresponding to KBLI code 46691, then click the “Fulfillment of Requirements” button in the Ministry/Agency (K/L) system
3. Document Submission: Switch to the Seralkes system, select the CDAKB menu, and upload the required documents.
4. Document Review: The submitted documents will be reviewed by the relevant authorities.
5. Audit Scheduling: The audit will be scheduled after the document review is completed
6. Audit Process: The audit is conducted through a Remote Audit and a Site Visit to evaluate whether all aspects of distribution and quality control for medical device distributors meet CDAKB regulations.
7. PNBP Payment: Business actors must make the payment for Non-Tax State Revenue (PNBP).
8. CAPA Process: After the audit, any evaluation findings requiring corrections must be addressed through Corrective Action Preventive Action (CAPA) in the OSS system.
9. Resume Creation: The resume and technical data attachments are prepared in the Seralkes system.
10. Certificate Issuance: The CDAKB certificate is issued through the OSS RBA system once all requirements are fulfilled.