للاطلاع على النماذج المصدرة باللغة الأنجليزية برجاء الضغط على الرابط
الإدارة العامة للسماح بالتداول
| النوع | التصنيف | الوصف |
|---|---|---|
| نموذج |
الإدارة العامة للسماح بالتداول (طلبات الإستيراد الخاص) |
التعهد الخاص بالافراد / الاشخاص |
| نموذج |
الإدارة العامة للسماح بالتداول (طلبات الإستيراد الخاص) |
التعهد الخاص بالجهات |
| نموذج |
الإدارة العامة للسماح بالتداول (طلبات الإستيراد الخاص) |
تعهد الآثار العكسية |
| نموذج |
الإدارة العامة للسماح بالتداول (طلبات الإستيراد الخاص) |
تعهد الشركات باستخدام الوارد لصالح الجهة |
| نموذج |
الإدارة العامة للسماح بالتداول (طلبات الإستيراد الخاص) |
توصيات |
| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
الإدارة العامة للسماح بالتداول |
تعهد الأطلاع على الأدلة التنظيمية الخاصة بتسجيل المستلزمات الطبية |
| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
الإدارة العامة للسماح بالتداول |
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| نموذج |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents) |
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| نموذج |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents) |
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| نموذج |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents) |
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| نموذج |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents) |
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| نموذج |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents) |
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| نموذج |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents) |
Packaging Certificate
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| نموذج |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents) |
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| نموذج |
General Administration for Market Authorization |
IVD Free sale template (CE)
|
| نموذج |
General Administration for Market Authorization |
IVD Free sale template (Non-CE) |
النماذج الخاصة بالإدارة العامة للتسجيل
| النوع | التصنيف | الوصف |
|---|---|---|
| نموذج |
GA of Registration (Local and imported) |
Sterilization Certificate |
| نموذج |
GA of Registration (Local and imported) |
Composition Certificate |
| نموذج |
GA of Registration (Local and imported) |
|
| نموذج |
GA of Registration (Local and imported)
|
MANUFACTURER’S DECLARATION OF CONFORMITY according to MDR |
| نموذج |
GA of Registration (Local and imported) |
Shelf Life Certificate |
| نموذج |
GA of Registration (Local and imported) |
Packaging Certificate |
| نموذج |
GA of Registration (Local and imported) |
Certificate of Analysis |
| نموذج |
GA of Registration (variation)
|
Letter of no change |
| نموذج |
GA of Registration (variation) |
Shelf Life Statement |
| نموذج |
GA of Registration (variation) |
Table of comparison (For codes) |
| نموذج | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Appraisal plan example |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Applied Standard List |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Validation Master Plan |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
usability-study |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
quality-plan |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Incident Report |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Essential Requirements |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Document Master List |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Design validation |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Design output Review |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Design Input Review Sheet |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Design change Request |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Declarations of interests |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
CERTIFICATE OF ANALYSIS |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Biological Evaluation Report |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Risk Control |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
MANUFACTURER’S DECLARATION OF CONFORMITY according to MDD |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Clinical Evaluation report |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Stability Study Protocol |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
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| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
PMCF Plan |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
Packaging Validation Protocol |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
شهادة تداول حر لمستلزمات طبية محلية ( MDD) |
| نموذج |
Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates |
شهادة تداول حر لمستلزمات طبية محلية ( MDR) |
النماذج الخاصة بالإدارة العامة لثبات
| النوع | التصنيف | الوصف |
|---|---|---|
| نموذج |
stability unit |
تعهد مطابقة البيانات المقدمة لإدارة الثبات |
| نموذج |
stability unit |
Stability Study Requirements |