Approval Letter for the Import of Medical Devices and In Vitro Diagnostic Medical Devices via the Special Access Scheme (SAS)
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Micro, Small, and Medium Enterprises (UMKU) Details
Parameter: All
Authority: Minister/Head of the Agency
Requirements:- Proof of Payment of Non-Tax State Revenue (PNBP) Duration: -
- Administrative Requirements Duration: -
- Technical Requirements Duration: -
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Obligations:
- Reporting on Product Utilization within 1 (one) month Duration: -
- Reporting on Product Re-Export for Exhibitions, no later than 14 (fourteen) days after the exhibition Duration: -
- Reporting on Adverse Events or suspected adverse effects of the use of Medical Devices entering through the Single Access System (SAS), no later than 7 (seven) days after the event Duration: -
Sector: Health
Status: Not available
Belongs to:
32503
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