Regulatory Guidelines for General Administration Of Marketing Authorization
| Type | Issue date | Description | Issue NO. |
| Guide line | 09/2025 | Regulatory guideline of the procedures and rules of obtaining import approvals for laboratory and diagnostic equipment and their imported accessories | 02 |
| Guide line | 09/2025 | Regulatory guideline of issuance of import approvals of all types of medical devices | 02 |
| Guide line | 09/2025 | Regulatory guideline of issuing import approvals for medical equipment and their accessories | 02 |
Regulatory Guidelines for General Administration Of Registration
| Type | Issue date | Description | Issue NO. |
|---|---|---|---|
| Guide line | 09/2025 | Regulatory Guideline for Procedures of Registering Imported and Local Medical Devices holding International Quality Certificates | 02 |
| Guide line | 09/2025 | Regulatory Guideline of Registration of Locally Manufactured Medical Devices not holding International Quality Certificates | 02 |
| Guide line | 09/2025 | Regulatory Guideline of the Procedures and Rules Organizing the changes done to a Registration license Data of a Medical Device |
03 |
Regulatory Guidelines for General Administration Of Marketing Authorization and Registration
| Type | Issue date | Description | Issue NO. |
|---|---|---|---|
| Guide line | 12/2021 | 01 | |
| Guide line | 07/2023 | Regulatory Procedure of Importing and Registering Medical Devices, Medical and Laboratory Equipment and In vitro Diagnostics that are marketed in Great Britain (England - Wales - Scotland) and not Required to be Marketed in the European Union | 02 |
| Guide line | 08/2023 | Regulatory procedure of importing and registering medical devices ,medical and laboratory equipment and In Vitro Diagnostics circulated according to Japanese regulation | 01 |