EDA - Notice to applicant Central Administration of Medical Devices

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General Administration of Medical Devices Marketing Authorization

تاريخ الأصدار	الوصف	رقم الأصدار
10/2023	Enforcement mechanism of the European parliament resolution(decision) REGULATION (EU) 2023/607 of March 2030 on the transitional grace periods granted for the implementation of rules and procedures of MDR and IVDR	02
08/2024	Procedures for Issuing Replacements for Lost or Damaged Documents	01
08/2024	Updating the categories of Medical Devices allowed for obtaining Annual Importation Plans	01
03/2025	Updating the Applicable Procedures for Issuing Annual Plans for Registered Medical Devices and submitting a Request for Change/Re-Registration/ New Registration	01
06/2025	Cases where Pharmaceutical and Biological Product Manufacturers must approach the Central Administration of Medical Devices (CAMD) to obtain an Import Approval or a Non-Jurisdiction statement.	01
09/2025	Mechanism for facilitating the procedures for the registration and issuance of import approvals for medical devices, medical equipment, and IVDs	02
11/2025	Essential Requirements for Receiving Applications for Importation Approvals, Precautionary Release, and Annual Importation Plans via the MeDevice Electronic Platform	01
11/2025	Minimum Requirements for Receiving Applications for Import Approvals of Medical equipment and their Spare Parts, Annual Approvals, Unified Procurement Authority (UPA) Approvals and Amendments to Import Approvals Via MeDevice Electronic Platform	01
11/2025	Minimum Requirements for Submitting Import Approval Requests for In-vitro Diagnostic medical devices and Laboratory Equipment/ Annual IVD Import Approvals/ Annual IVD Import Approval variations/ Imported IVD listing requests/ Local IVD listing requests/ Unified Procurement Authority (UPA) Files via the "MeDevice" Electronic Platform	01
01/2026	Procedures for the Market Placement of Medical Devices in Dosage Form	01

General Administration of Registration of Medical Devices

تاريخ الأصدار	الوصف	رقم الأصدار
08/2021	Notification Regarding the changes that may take effect as a result of applying of MDR (REGULATION (EU) 2017/745)	01
08/2023	Updating Procedures of Submitting Case Study File	02
10/2023	Enforcement mechanism of the European parliament resolution(decision) REGULATION (EU) 2023/607 of March 2030 on the transitional grace periods granted for the implementation of rules and procedures of MDR and IVDR	02
08/2024	Procedures for Issuing Replacements for Lost or Damaged Documents	01
08/2024	The mechanism for dealing with the changes mentioned in the MDD certificates extension letters issued by the Notified Body under MDR application in the event that they are not mentioned in the Registration License of the medical device.	01
09/2025	Mechanism for facilitating the procedures for the registration and issuance of import approvals for medical devices, medical equipment, and IVDs	02
09/2025	Regulation Procedures for Registration of Medical Devices with Pharmaceutical Dosage Form That have been previously Registered or Currently Under Registration as Pharmaceutical Products	02

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