On May 16, 2024, the Indonesia Ministry of Health issued an Announcement Number FR.03.01/E/884/2024 about the Implementation of the CDAKB Certificate (Good Distribution Practice of Medical Devices) as a Requirement for Marketing Authorization. The Ministry of Health (MoH) is providing a transition period from May 1st to June 30th, 2024. Therefore, Local Distributors and License Holders must have obtained the CDAKB Certificate, or have proof of the submission’s progress, by July 1st, 2024 in order to register a product with the MoH.
CDAKB is a set of guidelines established to standardize quality management across the Indonesian medical device market and includes the following.
- Quality management system
- Resource management
- Building and facilities
- Storage and inventory handling
- Product traceability
- Complaint handling
- Field safety corrective action
- Return system
- Destruction system
- illegal and unqualified medical devices recording
- Internal audit
- Management review
- 3rd party / Outsourcing activity
This means that from July 1, 2024, the implementation of CDAKB certificate mandatory requirements will apply when applying for a medical device distribution license.
Please refer to the attached file below for more information.
If you have any questions about medical device,
Please contact us with the below.
info@jnmglobal.net
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