Understanding CDAKB in the Medical Device Industry

The availability of medical equipment is a vital necessity for the government and society. As supportive instruments, these tools not only prevent, but also treat and maintain our health. To maintain the sustainability of the pharmaceutical industry, the distribution of medical equipment must be managed efficiently. Proper and efficient distribution supports medical services regulated in the CDAKB.

What is CDAKB?

In accordance with the Regulation of the Minister of Health of the Republic of Indonesia Number 4 Year 2014, every Medical Device Distributor and Branch of Medical Device. Good Distribution Practice (GDP) as referred to includes the following aspects: 

⦁ Quality management system; 

⦁ Resource management; 

⦁ Buildings and facilities; 

⦁ Storage and inventory handling; 

⦁ Product traceability; 

⦁ Complaint handling; 

⦁ Field Safety Corrective Action (FSCA); 

⦁ Return of medical devices; 

⦁ Disposal of medical devices;

⦁ Illegal and non-compliant medical devices; 

⦁ Internal audits; 

⦁ Management reviews; and 

⦁ Third-party activities (outsourcing activities).

Reference:
Permenkes No. 4 Tahun 2014
Petunjuk Teknis CDAKB

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