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【Important Notice】Statement on Unauthorized (“Grey Market”) Products
Dear Valued HIFU Clients,
Thank you for your continued support and trust in HIFU Ultrasound, which has become one of the leading brands in the aesthetic medical market. Ugintech Co., Ltd. has always been committed to ensuring the highest product quality and service standards, actively promoting market development, enhancing product value, and working hand in hand with medical institutions to improve customer satisfaction and create mutual success.
The introduction of safe and effective medical devices requires substantial time and investment from authorized distributors to obtain official approval from the Taiwan Food and Drug Administration (TFDA), as well as to establish professional teams to provide high-quality services and training. On May 1, 2021, the Medical Device Management Act came into effect, aiming to further ensure safe and effective medical services for the public.
However, it has recently come to our attention that unauthorized parties have illegally imported third-generation HIFU transducers and attempted to sell them to medical institutions, while falsely claiming to have legally obtained distribution rights. We hereby solemnly declare that Ugintech Co., Ltd. is the sole authorized distributor of Classys in Taiwan. Classys has not authorized any third parties to distribute or sell third-generation HIFU transducers in Taiwan.
We strongly remind our valued clients not to purchase uncertified or unauthorized transducers from unknown sources. The use of such unapproved medical devices not only risks violating relevant laws and regulations but also significantly increases the likelihood of medical disputes, potentially damaging your institution’s reputation. For your reference, relevant legal provisions and case examples are listed below.
We once again sincerely thank you for supporting the use of legally imported medical devices. With your trust, Ugintech can continue investing in market development and service quality improvements. We remain committed to serving our clients with professionalism and dedication, and to introducing more advanced medical devices to enhance treatment quality while creating mutual value and sustainable growth with our partners.
Yours sincerely,
Ken Chung
General Manager
Ugintech Co., Ltd.
2022/4/20
Relevant Provisions of the Medical Device Management Act on Illegal Importation and Use of Unauthorized (“Grey Market”) Medical Devices
Article 25
Paragraph 1
Manufacture or importation of medical devices shall require an application for registration and inspection with the central competent authority. Only upon approval and issuance of a medical device license may such activities be conducted.
Paragraph 3
Importation of medical devices shall be carried out by the license holder, registrant, or their authorized representative.
Article 60
Paragraph 1
Any person who manufactures or imports substandard medical devices as defined in Subparagraph 1, Article 8 shall be subject to imprisonment of up to five (5) years, detention, or a fine of up to NT$50,000,000, or a combination thereof.
Paragraph 2
Any person who knowingly sells, supplies, transports, stores, brokers, transfers, or displays with intent to sell the substandard medical devices referred to in the preceding paragraph shall be subject to imprisonment of up to three (3) years, detention, or a fine of up to NT$10,000,000, or a combination thereof.
Article 62
Paragraph 1
Any person who, with intent to sell or supply, violates Paragraph 1 of Article 25 by manufacturing or importing medical devices without approval, or violates Paragraph 2 of Article 25 by failing to apply for inspection and instead registering improperly, shall be subject to imprisonment of up to three (3) years, detention, or a fine of up to NT$10,000,000, or a combination thereof.
Paragraph 2
Any person who knowingly sells, supplies, transports, stores, brokers, transfers, or displays with intent to sell the medical devices referred to in the preceding paragraph shall be subject to the same penalties.
Doctor Prosecuted for Profiting from Illegal Use of Unapproved Aesthetic Drugs and Devices
June 3, 2020 – 15:47
(CNA Correspondent Su Mu-Chun, Taichung, June 3) — A physician surnamed Hsieh, who operated a legally registered aesthetic clinic, was found to have used unapproved aesthetic drugs and devices imported without approval from the Ministry of Health and Welfare (MOHW) for profit. Investigators from the Criminal Investigation Bureau (CIB) discovered the scheme, estimating the illicit gains at over NT$10 million. Hsieh was questioned and subsequently referred for prosecution in accordance with the law.
The CIB’s Sixth Investigation Corps, Second Division, stated today that police received intelligence indicating that the 37-year-old physician promoted his clinic on social media, falsely claiming that all aesthetic drugs and devices used were original manufacturer products. However, after attracting clients for consultations, he provided them with unapproved aesthetic drugs and medical devices for profit.
Under the direction of the Kaohsiung District Prosecutors Office, a special task force was formed with members from the CIB, New Taipei City Police Department Haishan Precinct, Taipei City Police Department Zhongshan Precinct, Kaohsiung City Police Department Lingya Precinct, and the Second Security Police Corps Criminal Investigation Unit.
Following surveillance and evidence gathering, authorities discovered that Hsieh operated clinics and residences in Taipei, New Taipei, and Kaohsiung, where he was using unapproved Ulthera ultrasound lifting devices and transducers to treat clients. On May 14, investigators searched his residence and clinics, uncovering substantial evidence.
At his rented residence in New Taipei City’s Sanchong District, police seized placenta extract and unidentified pharmaceutical products considered substandard drugs. At his clinic in Taipei’s Zhongshan District, they confiscated unapproved Ulthera ultrasound lifting devices, transducers, dermal fillers, and lifting threads, and took Hsieh into custody for further investigation.
Authorities noted that if legally imported with MOHW approval, an original Ulthera ultrasound lifting device costs around NT$2.5–3 million. Hsieh, however, obtained illegal devices for just over NT$1 million each and tampered with the transducer programs—originally limited to 2,400 ultrasound shots per cartridge—modifying them to fire up to 10,000 shots. Combined with the use of illegal drugs, he generated substantial illegal profits.
Investigators estimate that over hundreds of patients were affected during more than five years of operation, with illicit profits exceeding NT$10 million. Hsieh was referred to the Kaohsiung District Prosecutors Office on charges of violating the Pharmaceutical Affairs Act.