CDAKB (Good Distribution Practices for Medical Devices)
CDAKB, or Good Distribution Practices for Medical Devices, is mandatory for medical device distributors in Indonesia to ensure the safety and quality of distributed products. According to Dra. Eka Purnamasari, Apt., MKM, Director of Medical Device Supervision, during a PJT training event in Semarang, “Only 30% of registered distribution facilities in Indonesia meet CDAKB standards, according to the Ministry of Health.”
In accordance with the obligations of medical device distributors as outlined in Annex II of Government Regulation No. 5 of 2021, CDAKB certification must be obtained before commencing operational activities to ensure products meet quality and safety requirements.
Benefits of CDAKB compliance include:
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Consistency in storage, handling, distribution, and traceability
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Regulatory compliance
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Cost-effectiveness
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Customer satisfaction
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Continuous improvement
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Data-driven operations
The ultimate goal is to ensure that distributed medical devices are safe, high-quality, and beneficial.
The CDAKB audit at PT. Multi Sinergi Anugrah Sejahtera on November 7, 2023, proceeded smoothly and satisfactorily. The audit was attended by representatives from the Ministry of Health, including Ms. Rizky Firstya Novani and Mr. Muhammad Taufiq, as well as the Central Java Provincial Health Office, represented by Ms. Raharti Sulastini.
Several observations were noted during the audit; however, with strong commitment, PT. Multi Sinergi Anugrah Sejahtera is taking prompt action to address these notes and uphold CDAKB standards.
