Laws and Regulations

Requirements for Inspections and Quality Management System for Medical Devices (MDS – REQ10)

Requirements for Licensing of Medical Devices Establishments (MDS-REQ9)

Requirements for Medical Devices Marketing Authorization (MDS-REQ 1)

Requirements for Post-Market Surveillance of Medical Devices (MDS – REQ11)

Requirements for Safe Use of Medical Devices Inside Healthcare Facilities (MDS-REQ 3)

Requirements for the Import and Clearance of Medical Imaging Materials and Particle Accelerators Used in Radioisotopes Formation for Medical Applications

Requirements for Transporting and Storage of Medical Devices (MDS – REQ 12)

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 of transport and storage of pharmaceutical products subject to the supervision of the drug sector through customs ports

Requirements on Importation and Shipments Clearance of Medical Devices (MDS-REQ5)

Requirements to be Followed by E-Commerce Stores