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

  1. Requirements:
    1. Certificate of Medical Device Distribution Duration: -
    2. Electronic production reports for medical devices Duration: -
    3. Data on the distribution permit of Medical Devices Duration: -
    4. Quality guidelines Duration: -
    5. Conducted internal audits Duration: -
    6. Conducted management reviews Duration: -
    7. Master List of Documents for the implementation of the CDAKB quality management system Duration: -
    8. Quality procedures and records Duration: -
    9. Issuance of certificates based on a comprehensive audit of distribution facilities Duration: -
  2. Responsibilities:
Sector: Health
Status: Available
Belongs to:
46691

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