Certificate of Good Manufacturing Practice (GMP) for Medical Devices
UMKU Details
Parameter: All
Authority: Minister/Head of Agency
-
Requirements:
- Issuance of Certificates based on comprehensive audits of production facilities Duration: -
- Quality guidelines Duration: -
- Conducted internal audits Duration: -
- Conducted management reviews Duration: -
- Master Document List for the implementation of the quality management system CPAKB Duration: -
- Quality procedures and records Duration: -
- Production Certificate for Medical Devices (for High-Risk) Duration: -
- Electronic production reports for medical devices Duration: -
- Marketing Authorization data for Medical Devices Duration: -
- Responsibilities:
Sector: Health
Status: Available
Belongs to:
32503
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