GLGlossary
Plain-language definitions of the terms that come up in Korean medical device regulatory work.
General information · confirm your specific case in consultation
GL-01Terms
01
The process of proving to the regulator that a device is safe and its performance is verified, and obtaining permission, before it can be sold.
The procedure and the time it takes can vary depending on which class the device falls under. The documents you prepare consist of materials that demonstrate the product's safety and performance. A regulatory consultant's role is to organize the procedure and materials and prepare the regulator response together with you.
02
A grouping of medical devices by risk level. The higher the class, the deeper the verification process.
Because the class a product is assigned to can set the direction of the entire subsequent procedure, classification is the first step in preparing for approval. Even products that look similar can be classified differently depending on how they work and their intended use. The exact classification of a specific product can be determined after reviewing its characteristics.
03
A set of documents showing that a product was designed and manufactured to standard.
It contains an overview-level account of the product's structure, intended use, and performance. Which items are required, and to what depth, can vary by device type and class. The detailed makeup required for a specific product can be advised through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.
We pre-review device class, required pathway, and data readiness free of charge, and reply within 1 business day. No sign-up.
