EDA - Regulatory guidelines for the central Administration of Medical Device

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Regulatory Guidelines for General Administration Of Marketing Authorization

Type	Issue date	Description	Issue NO.
Guide line	12/2021	Regulatory guideline of the procedures and rules of obtaining import approvals for laboratory and diagnostic equipment and their imported accessories	01
Guide line	02/2022	Regulatory guideline of issuance of import approvals of all types of medical devices	01
Guide line	04/2022	Regulatory guideline of issuing import approvals for medical equipment and their accessories	01

Regulatory Guidelines for General Administration Of Registration

Type	Issue date	Description	Issue NO.
Guide line	09/2021	Regulatory Guideline for Procedures of Registering Imported and Local Medical Devices holding International Quality Certificates	01
Guide line	07/2022	Regulatory guideline of the Registration of Locally Manufactured Medical Devices without International Quality Certificates	01
Guide line	12/2023	Regulatory Guideline of the Procedures and Rules Organizing the changes done to a Registration license Data of a Medical Device	02

Regulatory Guidelines for General Administration Of Marketing Authorization and Registration

Type	Issue date	Description	Issue NO.
Guide line	12/2021	Regulatory Guideline on Requirements for Unique Device Identification (UDI) for Medical Devices	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

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