Medical device regulation in Korea, from classification to market
Connect the Korean medical device regulatory pathway from classification and technical documentation review to GMP and market release.
Regulatory pathways
Blood Sugar Claims for a Pain-Relief Device: Reviewing Medical Device Advertising
This article distinguishes between efficacy claims beyond approval purposes using examples from the Ministry of Food and Drug Safety and explains how to verify product information against revised copies of advertising materials.
Regulatory pathways Clinical Trial Device Inventory: Reconciling Receipt, Use, and Return This article explains how to divide the quantities of medical devices acquired by an institution, the number returned by the client, and the current inventory, using a hypothetical case for comparison between records and physical inventory.
Regulatory pathways What Does Medical Device Classification Mean: Risk Classification and Performance Comparison Is a Class 4 medical device better? This article examines the meaning of classifications indicated by domestic medical device grades, and explains how to differentiate grades and performance in the product comparison table.
Regulatory pathways Comparing Current Approval Requirements Before Product Changes How do we connect the approval details that serve as criteria when reviewing changes to domestically manufactured items with the new specifications? We organize the review preparation with a hypothetical case of outer casing changes and a comparison table.
Regulatory pathways Medical Device Authorization in Korea: Five Things to Define Before Searching for a Product Category This article organizes the necessary product information before reviewing the pathway for medical device approval in Korea.
It details how to specify the scope of review based on intended use, mechanism of action, composition, conditions of use, and differences from existing products.
Regulatory pathways Clinical Trial Device Inventory: Reconciling Receipt, Use, and Return This article explains how to divide the quantities of medical devices acquired by an institution, the number returned by the client, and the current inventory, using a hypothetical case for comparison between records and physical inventory.
Regulatory pathways What Does Medical Device Classification Mean: Risk Classification and Performance Comparison Is a Class 4 medical device better? This article examines the meaning of classifications indicated by domestic medical device grades, and explains how to differentiate grades and performance in the product comparison table.
Regulatory pathways Comparing Current Approval Requirements Before Product Changes How do we connect the approval details that serve as criteria when reviewing changes to domestically manufactured items with the new specifications? We organize the review preparation with a hypothetical case of outer casing changes and a comparison table.
Regulatory pathways Medical Device Authorization in Korea: Five Things to Define Before Searching for a Product Category This article organizes the necessary product information before reviewing the pathway for medical device approval in Korea.
It details how to specify the scope of review based on intended use, mechanism of action, composition, conditions of use, and differences from existing products.