S.THEPHARM Co., Ltd. announced that its flagship hyaluronic acid filler, 'QTFill PLUS,' has obtained the CE MDR certification under the European Medical Device Regulation.

This certification signifies the official recognition of the product's international safety and efficacy, and it is noteworthy as the first MDR certification for a domestic HA filler product containing lidocaine.

The European MDR (Medical Device Regulation), which has been fully implemented since May 2021, is a significantly strengthened regulation compared to the previous MDD, requiring stringent conditions such as △enhanced clinical evaluation standards △long-term safety verification △refinement of risk management procedures △strengthening of manufacturing and quality control standards.

QTFill PLUS passed the entire MDR review process, receiving high evaluations in all areas including the safety of raw materials and manufacturing processes, consistent quality maintenance, and clinical efficacy data.

S.THEPHARM plans to use this certification as a strategic turning point for global market expansion, aiming to strengthen its brand influence not only in Europe but also in overseas markets such as the Middle East and Asia. In the European medical aesthetics market, which has transitioned to the MDR system, safety and regulatory compliance have emerged as key criteria for product selection, and securing CE MDR certification is expected to positively impact the expansion of partnerships with overseas buyers and medical professionals.

Oh Se-eok, CEO of S.THEPHARM, stated, “The acquisition of MDR certification is not a temporary achievement but signifies the ability to maintain a stable global supply system even in a strengthened regulatory environment,” adding, “We will further enhance our global competitiveness through continuous technological innovation and quality advancement.”

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