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 |
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 |
|
| 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 |
Packaging Validation Protocol |
General Administration for Market Authorization
| type | GA | DEC |
|---|---|---|
| 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 |