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【Seoul, South】Debate Intensifies on Regulatory Framework for Injectable ECM Tissue Grafts: Experts Divided

Jul 28, 2026

Editor’s Note

This article examines the ongoing debate over safety regulations for injectable ECM tissue grafts, highlighting a consensus on the need for improvement but divergent views on application and management standards.

Consensus on Need for Improvement, but Divergent Views on Application and Management Standards

The government has launched a study to strengthen consumer safety management and is reviewing cases from major countries.
On the 28th, the Korea Medical Bio Journalists Association held a symposium at the Korea Press Center in Jung-gu, Seoul, under the theme “Discussing the Regulatory Gap of Injectable ECM Tissue Grafts – The Need for Safety Verification.” [Photo by Reporter Lee Jae-hyung]
Discussions surrounding the regulatory framework for injectable ECM (extracellular matrix) tissue grafts have officially begun. With various opinions presented by experts, industry attention is focused on the future direction of institutional improvements.
On the 28th, the Korea Medical Bio Journalists Association held a symposium titled “Discussing the Regulatory Gap of Injectable ECM Tissue Grafts – The Need for Safety Verification” at the Korea Press Center in Jung-gu, Seoul. Experts from the medical, legal, and academic fields addressed clinical safety verification and the need for institutional improvements.
Professor Shin Hyun-young from the Department of Family Medicine at Seoul St. Mary’s Hospital, Catholic University, presented her views as a clinician on the topic of “Clinical Safety and Policy Direction of Injectable ECM Tissue Grafts.”
According to Professor Shin, most ECM tissue grafts are used by freeze-drying and pulverizing skin dermal tissue from overseas donors, then mixing it with saline solution for direct injection into the skin.

“Unlike therapeutic tissue transplantation, there is currently no sufficient clinical safety verification or management system in place for cosmetic skin injections,” she pointed out.

She also criticized that while many injectable skin boosters used in medical settings are managed as medical devices after undergoing clinical trials and regulatory approval, ECM tissue grafts are distributed as human tissue without undergoing the same level of safety verification.
However, some voices urge a cautious approach to such criticisms. A legal expert stated:

“Under the premise that ECM injections can already be regulated under current laws, we should not overemphasize the criminal and administrative responsibilities of those involved in manufacturing, distribution, and procedures,” he emphasized.

According to Article 2, Paragraph 1 of the Medical Device Act, a medical device is defined as “instruments, machines, devices, materials, software, or similar products.” Whether ECM injections fall under this definition must be determined by comprehensively considering the product’s form and intended use.

“A separate legal review is needed to determine whether substances derived from human tissue qualify as ‘materials’ under the relevant law,” the expert added. “Simply equating them with existing Class 4 medical devices like hyaluronic acid fillers would be a hasty conclusion.”

Various opinions were also raised regarding clinical safety. Professor Lee Jong-hee from the Department of Dermatology at Samsung Medical Center shared his perspective from a dermatological safety standpoint.

“While no serious adverse events have been reported in clinical studies to date, the study scale and observation periods are limited,” Professor Lee said. “It is difficult to say that they fully reflect the repeated administration environment in actual clinical practice.”

A panel discussion was held at the symposium “Discussing the Regulatory Gap of Injectable ECM Tissue Grafts – The Need for Safety Verification.” [Photo by Reporter Lee Jae-hyung]
Some view injectable ECM human tissue grafts as a technology with biocompatibility and safety based on long-term clinical experience. Professor Won-jae Lee from the Department of Plastic Surgery at Severance Hospital stated:

“We have been using acellular allogenic dermis in the field for over 25 years, and human tissue is managed more strictly than medical devices,” he said.

He reported that products obtained through ethical and lawful donation and rigorous processes demonstrate excellent biocompatibility immunologically, with almost no serious adverse reactions such as local or systemic toxicity.

“The Human Tissue Act is based on ‘ethicality’ and ‘medical validity,'” Professor Lee emphasized. “Structural restoration and functional recovery of the skin align with the essential purpose of human tissue transplantation.”

He added, “For tissue restoration, using the body’s own original tissue is the most biocompatible and safe approach.”
Regulatory authorities state they are pursuing policies to strengthen safety management. Lim Sang-woo, Team Leader of the Advanced Biopharmaceuticals TF at the Ministry of Food and Drug Safety (MFDS), stated:

“We agree that safety management is necessary for products made from powdered human tissue,” he said. “We have initiated research projects, including reviewing safety cases from major countries, to improve the system.”

The MFDS plans to revise the tissue transplantation outcome record form to strengthen labeling regulations for consumers. Additionally, regulations are being prepared to provide a basis for consumer reporting of adverse events beyond serious side effects.
Meanwhile, Professor Yang Sung-il from Seoul National University Bundang Hospital, who served as the moderator, evaluated ECM tissue grafts as an example of innovation potential in Korea’s bio-cosmetic medical technology. However, he made it clear that sustainable market growth is only possible with public trust in health and safety.
Concluding the discussion, Professor Yang said:

“I hope this symposium serves as a starting point for establishing a rational and harmonious regulatory framework that considers both industrial development and public safety.”

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⏰ Published on: July 28, 2026