Certificate for Good Distribution Practice of Medical Devices (CDAKB - Cara Distribusi Alat Kesehatan yang Baik) for Branches of Medical Device Distributors

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UMKU Details

Parameter: Business coverage in the Province

Authority: Governor

  1. Requirements:
    1. Medical Device Distribution Permit (if applicable) Duration: -
    2. Data on the distribution permit of Medical Devices Duration: -
    3. Quality guidelines Duration: -
    4. Conducted internal audits Duration: -
    5. Conducted management reviews Duration: -
    6. Master List of Documents for the implementation of the CDAKB quality management system Duration: -
    7. Quality procedures and records Duration: -
    8. Proof of Non-Tax State Revenue (PNBP) payment Duration: -
    9. Electronic distribution reports for medical devices (if applicable) Duration: -
    10. List of distributed products Duration: -
    11. Building layout Duration: -
  2. Responsibilities:
Sector: Health
Status: Available

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