2023-03-23
Laws and Regulations
Laws and Regulations
Regulations Exceptions List Click Here
Requirements for Post-Market Surveillance of Medical Devices (MDS – REQ11)
National Diagnostic Reference Levels
Requirements for Clinical Trials of Medical Devices (MDS-REQ 2)
Requirements for Licensing of Medical Devices Establishments (MDS-REQ9)
Requirements for Inspections and Quality Management System for Medical Devices (MDS – REQ10)
Requirements for Unique Device Identification (UDI) for Medical Devices (MDS – REQ 7)
Requirements of Importation and Re-Exportation for Radioactive Materials Used in Medical Applications (MDS-REQ6)
Requirements for Shipments Clearance of Medical Devices at Ports of Entries( MDS-REQ 5 )
Requirements for Importation of Minimally Manipulated Biological Products Intended for Human Application
2023-02-07
2022-12-26
2022-08-18
2022-07-28
2022-06-16
2022-04-12
2022-04-06
2022-01-31