"Alleviating Burden on Small Businesses"... MFDS Implements Medical Device Liability Compensation Mutual Aid

The Ministry of Food and Drug Safety announced on the 1st that it will begin recruiting companies to join the ‘Medical Device Liability Mutual Aid,’ a system that secures joint funds for compensating affected patients, through the Korea Medical Devices Industry Association.

The Medical Device Liability Mutual Aid is a system being promoted after gathering opinions from industry and consumers due to concerns that new and small businesses face high liability insurance premiums, and some products have difficulty subscribing to insurance products, potentially creating blind spots in compensation when accidents occur. It guarantees coverage for all product categories and sets mutual aid fees at less than 0.7% of sales revenue.

In the mutual aid system, when an accident occurs, a third-party causality investigator (Korea Medical Device Safety Information Center) will conduct a fair and objective investigation of the cause of the accident to effectively resolve disputes and strengthen patient rights protection.

Additionally, a Financial Management Committee composed of medical device experts, lawyers, and accountants will manage and operate mutual aid fees, handle mutual aid payments, prepare evaluation reports, and perform other roles to ensure transparency and stability in the operation of the mutual aid system.

The Ministry of Food and Drug Safety plans to pursue legislative amendments to properly carry out the mutual aid project and strengthen supervisory authority, as well as expand personnel for causality investigations. A ministry official stated, “Based on future accident statistics, we will review the appropriateness of compensation standards and conduct accident prevention education, operating the compensation system with patient protection as the top priority.”

This content was produced with the assistance of AI translation services.