South Korea regulates medical devices through the Ministry of Food and Drug Safety (MFDS). The MFDS, formerly known as the Korea Food and Drug Administration (KFDA), oversees the safety and efficacy of medical devices in the country. Similar to other regulatory authorities, the MFDS has implemented a classification system for medical devices to categorize them based on their intended use and level of risk. While specific details may have evolved since my last update, the classification system generally consists of several classes, each with its own regulatory requirements.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.