GA Of Registration
| type | GA | Dec |
|---|---|---|
| Form | GA of Registration | MANUFACTURER’S DECLARATION OF CONFORMITY |
| Form | GA of Registration | Composition Certificate |
| Form | GA of Registration | Sterilization Certificate |
| Form | GA of Registration | Certificate of Analysis |
| Form | GA of Registration | Packaging Certificate |
| Form | GA of Registration | Shelf Life and Storage condition Certificate |
| Form | GA of Registration | MD Free sale template (CE) |
| Form | GA of Registration | MD Free sale template (Non-CE) |
| Form |
GA of Registration (variation) |
Table of comparison |
| Form |
GA of Registration (variation) |
Shelf life statement |
| Form |
GA of Registration (variation) |
letter of no change |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Appraisal plan example |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Applied Standard List |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Validation Master Plan |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | usability-study |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | quality-plan |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | PMCF Plan |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Incident Report |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Essential Requirements |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Document Master List |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Design validation |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Design output Review |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Design Input Review Sheet |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Design change Request |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Declarations of interests |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | CERTIFICATE OF ANALYSIS |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Biological Evaluation Report |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Risk Control |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | MANUFACTURER’S DECLARATION OF CONFORMITY |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Clinical Evaluation report |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Stability Study Protocol |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Packaging Validation Report |
| Form | Unit for Registration of Locally Manufactured Medical Devices Without International Quality Certificates | Packaging Validation Protocol |
General Administration for Market Authorization
| النوع | التصنيف | الوصف |
|---|---|---|
| Form |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents) |
Composition Certificate |
| Form |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents |
MANUFACTURER’S DECLARATION OF CONFORMITY (IVDR) |
| Form |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents |
Legal liability & Product Description |
| Form |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents |
MANUFACTURER’S DECLARATION OF CONFORMITY (IVDD) |
| Form |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents |
Technical File for IVD Product Registration |
| Form |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents |
Packaging Certificate |
| Form |
General Administration for Market Authorization (Department of Registration of Laboratory Reagents |
Shelf-Life Certificate |
| Form |
General Administration for Market Authorization |
|
| Form |
General Administration for Market Authorization |