Contract with Mexican Company Underway… Establishing Foundation for Entry into South American Market and Aiming for Global Success through MDSAP Certification

Tentech (CEO Han Dong-ok) announced that it has passed the INMETRO (National Institute of Metrology, Standardization, and Industrial Quality) audit, an essential step for entering the South American medical device market in Brazil.

INMETRO is the institution that conducts conformity assessments for products that intend to be exported to Brazil. In addition to INMETRO, products must also pass mandatory certification processes from the Brazilian Health Regulatory Agency (ANVISA) or the National Telecommunications Agency (ANATEL) in order to be allowed for export. To obtain the certification, products must undergo product testing and factory audit.

Tentech officials stated, "On the 20th of November, we completed the essential step for entering the Brazilian market by passing the factory audit for the INMETRO." They added, "10THERMA radio frequency lifting device, designed to improve skin elasticity and reduce wrinkles, met the required standards after being highly evaluated for its electrical and mechanical safety, as well as its manufacturing environment and processes."

According to the company, Tentech secured a local distribution network through an exclusive contract with Premium Tech in Brazil last year. Furthermore, Tentech is preparing to sign a contract with a Mexican company, laying a solid foundation for stable entry into the South American market, where the demand for medical devices is high.

CEO Han Dong-ok emphasized, "The successful INMETRO audit reaffirms the excellence of 10THERMA. Based on this, we will continue to supply trusted products to global markets." He also stated, "Tentech is working towards obtaining the Medical Device Single Audit Program (MDSAP) certification, which is required in five developed countries: the U.S., Canada, Japan, Australia, and Brazil, to achieve greater success worldwide. We will continue to innovate and expand our presence in the global aesthetic medical device sector."