To ensure the safety, quality, and efficacy of medical devices domestically, and to enhance compliance with the Good Distribution Practices for Medical Devices (CDAKB), the Ministry of Health has issued a new policy as outlined in Announcement Number FR.03.01/E/884/2024.
In accordance with the Ministry of Health Regulation Number 4 of 2014 on Good Distribution Practices for Medical Devices, Article 2, Paragraph (1), all medical device distributors and their branches are required to implement CDAKB in their distribution activities. The aim of CDAKB is to ensure that distributed medical devices meet the standards for their intended use. CDAKB provides comprehensive guidelines for organizations involved in the ordering, storage, transportation, and distribution of medical devices.
To enforce this, the Ministry of Health will require CDAKB certification for medical device distribution license applications. The implementation will proceed as follows:
- Socialization for the implementation of CDAKB will take place from May 1 to June 30, 2024, through the regalkes system.
- The requirement for CDAKB certification in the application for medical device distribution licenses will be enforced starting July 1, 2024.
- Further information regarding CDAKB certification applications can be found at the link: sertifikasialkes.kemkes.go.id.
All stakeholders are encouraged to comply with these regulations to support higher standards in the production and distribution of medical devices within the country.
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