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Officially Released！China’s First Group Standard for Injectable Collagen in Skin Quality Evaluation – Tigermed-Jyton as Key Developer

The group standard titled "The Evaluation Methods of Collagen Extracted from Tissue for Injection to Improve Skin Texture and Complexion" (Standard No. T/FDSA 0135-2026) was recently issued and implemented by the China Food and Drug Enterprise Quality Safety Promotion Association (CFDQSPA). This is the first specialized group standard in China for evaluating skin quality and complexion improvement using injectable tissue-derived collagen. It marks a major milestone as the country’s collagen-based aesthetic medicine field transitions from an “experience-driven” to an “evidence-based standardization” phase. As the only CRO (Contract Research Organization) involved, Tigermed-Jyton played a key role in developing this standard, contributing its professional expertise to build the industry’s technical standard system.

Addressing the Industry Standards Gap and Reducing Dependence on Foreign Experience

In recent years, as the medical aesthetics industry has grown rapidly, the clinical use of injectable tissue-derived collagen to improve skin texture and complexion has become increasingly common. However, before this standard was released, China lacked dedicated evaluation criteria for this purpose. The industry long faced the challenge of having no standards to follow, and related assessments often had to rely heavily on existing foreign experience and methods, lacking systematic guidance aligned with China’s regulatory and clinical landscape.

The release of this group standard establishes, for the first time, a comprehensive, localized evaluation framework suited to China’s regulatory system and clinical reality. It effectively fills a standardization gap in this field, significantly reduces reliance on foreign experience, and enhances China’s independent evaluation capabilities and industry influence in collagen-based aesthetic medicine.

Defining Key Clinical Parameters to Improve Safety and Standardization

Notably, the standard defines concrete technical parameters such as the intended use scope, subject selection criteria, and optimal facial injection depth. These guidelines directly address clinical practice, helping physicians and practitioners more accurately determine indications, identify contraindications, standardize injection depth and dosage, reduce the risk of adverse events, and ultimately ensure treatment safety and outcomes for aesthetic patients.

As the only CRO among the participating organizations, Tigermed-Jyton leveraged its deep expertise in medical devices and aesthetic medicine. It led core tasks including expert coordination, standard drafting, and consensus discussion, thereby ensuring the scientific rigor, accuracy, and practicality of the standard.

With over ten years of experience, Tigermed-Jyton’s aesthetic medicine team has executed more than 140 projects across over 60 research centers and with more than 100 investigators. Its portfolio covers major product categories including collagen, hyaluronic acid fillers, botulinum toxin, and laser/energy-based devices. The team has accumulated extensive experience in facial wrinkle correction, contour improvement, pigmented lesion treatment, and skin rejuvenation.

Tigermed-Jyton has supported the approval and market launch of several milestone products, including:

l  China’s first CaHA (calcium hydroxylapatite) filler

l  China’s first Class III ultrasound aesthetic device

l  The world’s first PLLA filler

l  The world’s first Class III radiofrequency aesthetic device

l  The world’s first Class III HA filler skinbooster

l  The world’s first recombinant botulinum toxin type A filler

These achievements fully demonstrate Tigermed-Jyton’s leading capabilities in innovative aesthetic products. The company offers professional, compliant, and efficient integrated clinical research solutions for aesthetic medicine products, supporting high-quality product development and commercialization.

The release of this group standard is not only a significant achievement for Tigermed-Jyton in advancing aesthetic medicine standardization, but also reflects its responsibility and commitment as a leading medical device CRO to foster high-quality industry development. Moving forward, Tigermed-Jyton will continue to deepen its involvement in aesthetic medicine and other innovative healthcare fields, helping to build a more scientific and standardized industry ecosystem.