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Instrument Technology Research Center has become Asia's only certification agency for 3D-printed medical devices

Instrument Technology Research Center (ITRC) of National Applied Research Laboratories (NARLabs) has become the world's first 3D-printed medical device certification agency to be recognized by the international authoritative product safety certification body, the UL Company. The core laboratory of Hsinchu Biomedical Science Park under the guidance of ITRC, has comprehensively planned and established R&D facilities and service platforms that conformed to international medical device regulations. They have successfully become the only certification agency for 3D-printed medical devices in Asia and effectively solve 90% of the certification process required before 3D-printed medical devices could go into the market and help manufacturers reduce at least 50% of the time and cost in getting approval from the US Food and Drug Administration (FDA) for marketing.

Connecting internationally, strengthening Taiwan's innovative advantage in 3D-printed medical supplies

In recent years, 3D printing technology has been widely used in the medical industry. Besides overcoming the bottlenecks and limitations of traditional processing and preventing material wastage, 3D printing can also decrease the time taken for design and production of complex workpieces and improve efficiency in production and medical treatment. Hence 3D printing has attracted the attention of many countries. Due to continuous discussion on the issue of global aging phenomenon, the demand for biotechnology, medical and healthcare industries have been increasing, and output from medical device industries has also been continuously rising. Due to its technological advantage of high customization, 3D-printed medical devices have been viewed as technology with high potential for future high-end medical devices in personalized medical treatment.

After two years of hard work in the core laboratory of the Hsinchu Biomedical Science Park, ITRC has successfully established "Biocompatibility certification" and "Validation of mechanical properties" that conform to international medical device regulations for 3D-printed medical devices. ITRC has also collaborated with the National Laboratory Animal Center in the establishment of three certification projects such as "Preclinical animal experiments", and these three certification projects have been approved by the UL Company.

In the future, manufacturers from various countries will send their 3D-printed medical device products to ITRC. The UL Company will first determine the appropriate test item and testing method for the 3D printed material before handing the materials over to ITRC for carrying out material testing and submission of a test result report. As long as the 3D-printed product has passed certification by ITRC, approval by the UL Company will simultaneously be obtained. The UL Company is an exclusive partner of the Office of Regulatory Affairs (ORA) of the US FDA. Hence, once approval is given by the UL Company, it is equivalent to obtaining FDA approval in an accelerated process.

Before 3D-printed medical device products have obtained US FDA approval for marketing, these products must first obtain four types of certifications ("Biocompatibility certification", "Validation of mechanical properties", "Preclinical animal experiments" and "Human experiments") based on the expected use of the medical device. In the future, if products can pass the first three certification items in ITRC, only "Human Experiments" is required to be carried out in addition for US FDA certification and approval for marketing in the US.

Overturning the medical device industry, improving medical standards

NARLabs has organized an introduction "Asia's only 3D-printed medical device certification agency" and "signing of cooperation contract between NARLabs and UL Company" ceremony today (April 26) at the Taipei Technology Building. As this signing ceremony has important significance, local and foreign representatives such as Mr. Fong-Chin Su, the Deputy Minister of the Ministry of Science and Technology; Mr. Wei-Cheng Lin, the Bureau Chief of the Southern Taiwan Science Park; Mr. Hsin-Yuan Fang, the Chief Secretary of the China Medical University Hospital; Dr. Dah-Shyong Yu, the Attending Physician of the Tri-Service General Hospital; Mr. Jenq-Jang Ou, the Director of the China Steel Corporation; Mr. Ching-Fu Lin, the Deputy General Manager of Anhui Xinke New Materials Co., Ltd.; Mr. Shih-Cheng Chobby Lai, the General Manager of the UK Renishaw (Taiwan) Inc.; and Mr. Wen-Peng Zeng, the Executive Assistant in Tongtai Machine & Tool Co., Ltd. have gathered here to witness a milestone in 3D-printed medical devices in Taiwan.

The Deputy Minister of the Ministry of Science and Technology, Mr. Fong-Chin Su gave a speech and expressed that based on the "Biomedical Industry Innovation Promotion Project" of Industrial Innovation in the Executive Yuan, the government actively promotes the goal of establishing Taiwan as a biomedical R&D industry center in Asia-Pacific through integrating the resources and strengths of Taiwan's industries, academia, and corporate institutions. Becoming the only 3D-printed medical device certification agency in Asia will enhance the economic benefits of Taiwan's biotechnology industry, and is an opportunity for overturning the medical device industry.

Connecting the future, creating a boom for 3D-printed medical devices in Taiwan

ITRC in Hsinchu Biomedical Science Park has successively fulfilled international medical device regulations such as ISO13485 (medical devices - quality management systems), ISO10993 (service platform for evaluating biocompatibility), electrical safety verification laboratory, the first domestic regulatory environment platform for surgical guidance usability, and ISO17025 (testing and calibration laboratories) and hence became the world's first 3D-printed medical device certification agency authorized by the UL company. Currently, ITRC has been actively planning a GLP-compliant biocompatibility testing laboratory and establishing a GMP-compliant additive manufacturing environment. ITRC hopes to expand the cooperation model between industry, academia, research institutes, and medical organizations, to become the most complete accelerator for development of medical devices in the country.

Ms. Simin Chou, the global vice president of digital manufacturing technologies at UL Company, mentioned that emerging 3D printing technologies has always been a focus of the UL Company in recent years. She predicted that in the next 10 years, this technology will bring about decisive changes to many industries. Safety verification is an important step for medical device products before they are available in the market. As a global product safety certification organization, the UL Company is also cautious with cross-industry alliances. She also thanked ITRC for their hard work, which gave the UL company confidence for long-term cooperation with ITRC, giving authorization to ITRC for carrying out certification of 3D-printed medical devices, and working together to shorten the time needed for marketing approval for products. In the future, the UL Company will bring in international sources, such as Singapore National University and National University Hospital, Nanyang Technological University and other international manufactures to work together for the development of the biomedical industry and technology.

The president of NARLabs, Dr. Yeong-Her Wang said that biotechnology applications are becoming more and more extensive, and the commercial opportunities and output driven by it are increasing more and more. In support of the development of biomedical technology in Taiwan, NARLabs has spared no effort in establishing a complete service platform for biomedical R&D technology to meet the needs of industry, academia, research institutes, and medical organizations. The strengths of ITRC in 3D-printed medical devices could effectively decrease the certification time and costs of 3D-printed medical device products before these are available in the market, assisting industries in obtaining accelerated US FDA marketing approval for products. This can improve the internationalization of Taiwan's domestic biomedical industry and promote a cluster effect in the medical device industries. Through these efforts, it is hoped that this could assist Taiwan's government in creating a boom for 3D-printed medical devices in Taiwan.

Group photo in front of the Victory Gate to 3D-printed Medical Devices. (From left to right: Dr. Yao-Joe Yang, Director General of ITRC; Mr. Tsung-Hung Chen, Managing Director of UL Taiwan; Mr. Fong-Chin Su, Deputy Minister of the Ministry of Science and Technology; Ms. Simin Zhou, UL Global Vice President of digital manufacturing technologies; Dr. Yeong-Her Wang, President of NARLabs; Mr. Shih-Cheng Chobby Lai, General Manager of the UK Renishaw (Taiwan) Inc.; Mr. Hsin-Yuan Fang, Chief Secretary of the China Medical University Hospital/ Mr. Jenq-Jang Ou, Director of the China Steel Corporation; Mr. Wen-Peng Zeng, Executive Assistant in Tongtai Machine & Tool Co., Ltd.; Mr. Ching-Fu Lin, Deputy General Manager of Thintech Materials Technology Co., Ltd;)

2017/5/15 updated