Certificate for Good Distribution Practice of Medical Devices (CDAKB) for Medical Device Distributors
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UMKU Details
Parameter: All
Authority: Minister/Head of Agency
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Requirements:
- Certificate of Medical Device Distribution Duration: -
- Electronic production reports for medical devices Duration: -
- Data on the distribution permit of Medical Devices Duration: -
- Quality guidelines Duration: -
- Conducted internal audits Duration: -
- Conducted management reviews Duration: -
- Master List of Documents for the implementation of the CDAKB quality management system Duration: -
- Quality procedures and records Duration: -
- Issuance of certificates based on a comprehensive audit of distribution facilities Duration: -
- Responsibilities:
Sector: Health
Status: Available
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