[KOREA] MFDS Medical Device Certification
1. Certification Overview In Korea, medical devices are regulated by the Ministry of Food and Drug Safety (MFDS). The legal […]
Medical Device
[CHINA] NMPA Medical Device Certification
1. Certification Overview China classifies medical devices into classes I, II, and III based on their risk level and evaluates
[INDIA] CDSCO Medical Device Certification
1. Certification Overview The Indian CDSCO classifies medical devices into a total of four classes, from A to D, based
[VIETNAM] DMEC Medical Device Certification
1. Certification Overview The existing medical device management department, DMEC (Director of Medical Devices and Construction), was completely abolished, and
[MEXICO] SSA Medical Device Certification
1. Certification Overview In order for all medical devices, pharmaceuticals, and medical supplies (including consumables) imported into Mexico and coming
[SAUDI ARABIA] SFDA Medical Device Certification
1. Certification Overview The SFDA defines medical devices as follows. “Medical device” refers to any machine, tool, application device, implantable
[PANAMA] MINSA Medical Device Certification
1. Certification Overview MINSA’s primary objective is to prevent public health risks by controlling the safety and quality of medical
[ECUADOR] ARCSA Medical Device Certification
1. Certification Overview ARCSA is the highest regulatory body responsible for regulating the safety, efficacy, and quality of medical devices,
[EUROPE] CE Medical Device Certification
1. Certification Overview Regulation (EU) 2017/745 (MDR), which integrates and replaces the existing Medical Device Directive 93/42/EEC (MDD) and the
[CANADA] MDEL/MDL Medical Device Certification
1. Certification Overview In Canada, medical devices refer to any tool or component used to treat, diagnose, or prevent diseases