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Form of CA Of medical device

Forms Of General Administration for Market Authorization

Forms Of General Administration for Market Authorization

Doccument Name

Classification

Type
Undertaking for Individuals / Individual Declaration

General Administration for Market Authorization

(Private Importation Requests)

 Form
Undertaking for Entities / Corporate Declaration

General Administration for Market Authorization

(Private Importation Requests)

 Form
Adverse Events Undertaking / Pharmacovigilance (PV) Commitment Letter

General Administration for Market Authorization

(Private Importation Requests)

 Form

Corporate Undertaking for Using Imported Goods Solely for the End-User Entity

General Administration for Market Authorization

(Private Importation Requests)

 Form

Recommendations

General Administration for Market Authorization

(Private Importation Requests)

 Form
تعهد استيراد العينات بغرض الأنتاج التجريبي General Administration for Market Authorization Form

Undertaking for Importing Raw Materials for Production to Export

 General Administration for Market Authorization Form

Undertaking for the Use of Imported Goods in Production

 General Administration for Market Authorization Form

Registration Samples Undertaking

 General Administration for Market Authorization Form

Undertaking for Medical Gloves Importers

 General Administration for Market Authorization Form

Undertaking to Submit Original Documents

 General Administration for Market Authorization Form

Minimum Data Requirement Undertaking

 General Administration for Market Authorization Form
تعهد استيراد العينات لأغراض غير تجارية General Administration for Market Authorization Form
undertaking for precautionary release General Administration for Market Authorization Form
Acknowledgment of Reviewing Regulatory Guidelines for Medical Device Registration General Administration for Market Authorization Form
تعهد استيراد العينات بغرض الأنتاج التجريبي General Administration for Market Authorization Form

Import Plans Undertaking

 General Administration for Market Authorization Form

Composition Certificate

General Administration for Market Authorization (Department of Registration of Laboratory Reagents)

 Form
MANUFACTURER’S DECLARATION OF CONFORMITY (IVDD)

General Administration for Market Authorization (Department of Registration of Laboratory Reagents)

 Form
MANUFACTURER’S DECLARATION OF CONFORMITY (IVDR)

General Administration for Market Authorization (Department of Registration of Laboratory Reagents)

 Form
Legal liability & Product Description

General Administration for Market Authorization (Department of Registration of Laboratory Reagents)

 Form
Packaging Certificate

General Administration for Market Authorization (Department of Registration of Laboratory Reagents)

 Form
Shelf-Life Certificate

General Administration for Market Authorization (Department of Registration of Laboratory Reagents)

 

 Form
IVD Free sale template (CE)

General Administration for Market Authorization

 Form
IVD Free sale template (Non-CE)

General Administration for Market Authorization

 Form

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