Certification Streamlines Audit Procedures for Key Global Markets
 
TENTECH (CEO Han Dong-ok), a global aesthetic medical device company, recently obtained certification for the Medical Device Single Audit Program (MDSAP), which will speed up its global market expansion.
MDSAP is a system that unifies quality management audits for medical devices among five participating countries of the International Medical Device Regulators Forum (IMDRF): the United States, Brazil, Japan, Canada, and Australia. Obtaining the certification allows manufacturers to have partially or fully exempted from each country’s GMP audits.
This achievement enables TENTECH to simplify audit procedures with each country, reducing time and cost and thereby enhancing its competitiveness in global markets.
TENTECH has been building its brand awareness both domestically and internationally with its frontline devices “10THERMA” and “10THERA.” Especially, “10THERMA” has been received positive feedback from medical professionals and patients for delivering high energy to maximize treatment effects while reducing pain and side effects.
The next-generation HIFU device “10TRIPLE” features a 3-Line simultaneous irradiation system to maximize the effect after treatment. It is designed with seven different types of cartridges, enabling rapid treatment of large areas and precise treatment of delicate areas. The 3-Line and pen-type cartridges deliver energy to the subcutaneous and SMAS layers without damaging the skin surface, promoting regeneration of collagen and elastin fiber to provide a significant lifting effect.
Han Dong-ok, CEO of TENTECH, stated, “This MDSAP certification proves that TENTECH has established a world-class quality management system and the capability to produce outstanding products. We will continue our efforts to enter new markets, strengthen global credibility, and enhance our competitiveness”
Meanwhile, TENTECH aims to sell 300 units domestically by the end of this year and 1,000 units globally by next year. The company is currently pursuing regulatory approvals in Asia, Europe, and the Middle East, and has already contracted distribution agreements with major countries such as Taiwan, Hong Kong, Indonesia, and Vietnam.