MDREX Newsletter

2024.08.26

Announcement of the Amendment (draft) to the Medical Devices Act on the Scope

and Method of Relief for Damages caused by Medical Device Adverse Events.

The current Medical Devices Act requires manufacturers and importers of medical devices that are designed to be implanted in the human body for more than 30 consecutive days to subscribe to a liability insurance or a mutual aid program to provide damage relief to patients who suffered death or serious harm resulting from adverse events while using such medical devices. (Medical Devices Act, Article 43-6) For this reason, manufacturers and importers of such products comply with the relevant obligations by subscribing to a liability insurance sold by insurance companies or to a mutual aid association operated by the Korea Medical Devices Industry Association or the Korea Medical Device Association.

However, the recently proposed amendment (draft) to the Medical Devices Act, introduced by Representative Kim, Won-yi of the Democratic Party, includes a provision to increase the relevant obligations by extending the damage relief system currently operated under the Pharmaceutical Affairs Act to apply to medical devices. The relevant details are provided below.

1. Implementation of damage relief project by Ministry of Food and Drug Safety

• In addition to specified government subsidies, necessary funds are secured from medical device manufacturers and importers (basic charges + additional charges to be paid if adverse event occurs with the company’s products)

2. Constitution of Council of Deliberation on medical device adverse events.

• Investigates causal relationship of medical device adverse events
• Decides on payment of damage reliefs
• National Institute of Medical Device Safety Information designated as the agency to collect and analyze information related to the safety of medical devices, including adverse events, etc.

3. Allowance categories for relief of damages caused by medical device adverse events

• Medical expenses
• Lump-sum compensation for disability
• Lump-sum compensation for death
• Funeral expenses

With the expansion of the medical device market, various safety management systems and regulations continue to emerge, as demonstrated in the above proposed amendment. Therefore, it is essential for medical device manufacturers and importers to continuously monitor the amendments to relevant laws and regulations. MDREX, as a consulting firm specializing in the medical device field, quickly understands domestic medical device-related regulations and supports compliance with relevant laws for its customers manufacturing and importing medical devices. If you need assistance regarding medical device regulation or Korean market entry, please feel free to contact MDREX at pro@mdrex.co.kr.

Thank you