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【Seoul, South】Controversy Over Regulatory Gap Amid Spread of ‘ECM Skin Boosters’… ‘Need to Establish Safety Verification System’

Jul 28, 2026

Editor’s Note

This article examines the growing debate over ECM skin boosters, highlighting expert calls for stricter clinical and approval standards despite claims of safety based on existing clinical experience.

Experts: ‘Cosmetic Skin Injections Also Require Clinical and Approval Standards’

Some argue ‘Safety Proven by Existing Clinical Experience’
On the 28th, a commemorative photo was taken at the ‘Symposium on the Regulatory Gap of Injectable ECM Tissue Grafts and the Need for Safety Verification’ held at the Seoul Press Center. Provided by the Korea Medical Bio Journalists Association.
[Financial News] As the so-called ‘ECM skin booster’ procedure—injecting extracellular matrix (ECM) extracted from donated human tissue into the skin—rapidly spreads, voices are growing for the need to establish safety verification and regulatory systems. Unlike therapeutic tissue grafts, these are used for cosmetic purposes without separate clinical trials or approval procedures, leading to calls for institutional improvement.
The Korea Medical Bio Journalists Association held the ‘Symposium on the Regulatory Gap of Injectable ECM Tissue Grafts and the Need for Safety Verification’ at the Seoul Press Center on the 28th, with participation from the medical community, legal sector, consumer groups, and regulatory authorities, to discuss directions for institutional improvement.
Participants commonly pointed out that injectable ECM tissue grafts are managed as human tissue rather than medical devices, thus not subject to the full-cycle safety management system applied to medical devices, including clinical trials, product approvals, and adverse event reporting.

“Currently, many products process skin dermal tissue from overseas donors and inject it directly into the skin, but sufficient clinical safety verification and management systems for cosmetic use have not been established,” said Professor Shin Hyun-young of Seoul St. Mary’s Hospital, Catholic University. She added, “Europe prohibits the use of cadaver-derived tissue for cosmetic purposes, and China manages it as a medical device,” suggesting that Korea also needs institutional improvements to strengthen safety verification.

Attorney Lim Won-taek of Law Firm Moonjang argued that since the current Human Tissue Safety Act presupposes tissue transplantation for disease treatment and functional recovery, it is necessary to review whether the current practice of processing cadaver-derived tissue for cosmetic skin injection aligns with the law’s intent. He proposed restricting cosmetic use, incorporating injectable processed products into the approval system, and strengthening patient explanation obligations as improvement tasks.

In the panel discussion, opinions continued that safety verification equivalent to medical devices is necessary. Professor Lee Jong-hee of Samsung Medical Center said,

“It is difficult to directly apply safety data accumulated in reconstructive surgery to injectable formulations,” emphasizing the need for objective clinical data accumulation.

Professors Bae Ha-seok of Ewha Womans University Mokdong Hospital and Lee Ji-yoon of Chung-Ang University also stressed that verification systems for safety and residual chemicals upon repeated administration must be established.
On the other hand, some argued that the safety of injectable ECM tissue grafts has already been sufficiently confirmed. Professor Lee Won-jae of Severance Hospital stated,

“ECM-based tissue reconstruction technology has been used for decades in various fields such as burns, trauma, and cancer reconstruction, proving its safety and efficacy. Products from lawful donation and strict manufacturing processes have excellent biocompatibility and almost no serious adverse reactions.”

Professor Yang Sung-il of Seoul National University Bundang Hospital (former Vice Minister of Health and Welfare) said, “ECM tissue grafts show the innovative potential of the bio-cosmetic medical field, but to gain public trust, a safety management system must be supported. It is time for institutional supplementation, including chemical residue standards and legal classification systems.”

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Reporter Jeong Sang-hee
#ECM Skin Booster #Extracellular Matrix #Safety Verification #Regulatory System

28일 서울 프레스센터에서 열린 '피부 주입형 ECM 조직이식재 규제 공백을 논하다-안전성 검증 필요성 심포지엄' 참석자들이 기념촬영을 하고 있다. 한국의학바이오기자협회 제공

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⏰ Published on: July 28, 2026