On the 22nd of October, 2021, MIRDC worked with the medical device industry cluster of Southern Taiwan Science Park Bureau, MOST held the 2021 EU Medical Material MDR Testing and Certification Seminar at iBIOMED FLAGSHIP. The seminar mainly invited guests from ORIGO GROUP, Global Advanced Dental Education Center of Kaohsiung Medical University, DNV and SGS to share the information of medical device regulation, (MDR) as well as the professional field of each unit to enable the domestic medical device manufacturers with their products to be listed through the help from MIRDC. The number of the actual event have attracted more than 1,000 participants which was overwhelming

Medical device manufacturers around the world are facing major changes in the system which has been under the EU's regulatory framework for decades. The "Medical Device Regulations" (MDR) was officially released, which would come into effect since May 25, 2017. This framework is mainly used to regulate the entry of medical devices into the European Union (EU) market. Due to the impact of the COVID-19 pandemic, however, that has delayed the original compliance with the MDR requirements, those medical device manufacturers that have already been approved early days in which have to face a three-year transition period, in other words, this means that they must meet the requirements and approval of MDR before May 26, 2021.

The president of MIRDC, Chiu-Feng Lin stated that MIRDC have always provided services to medical device industry as well as continuingly paid attention to the EU MDR regulatory announcements and the timetable for manufacturers to switch, but it will take time to establish the relevant service capability. However, in response to the urgent needs of domestic medical device manufacturers in Taiwan, MIRDC invested resources to build a service team at the end of 2020 after reviewing the internal capabilities and focusing on service directions. In addition to assisting in the issuance of test reports for low-risk medical devices to speed up the schedule on the market, MIRDC advised the industry to build documents that meet the MDR requirements, and actively assisted the industry in solving various problems.

In the face of the vigorous development of the world’s medical industry, it is inevitable and necessary for Taiwan’s medical device to go internationally. Since Taiwan’s medical device industry is in fact a trend of small and medium-sized, this also reflects the strict requirements of the EU’s MDR in the document preparing to feel powerless. In addition to linking external and integrating internal resources, MIRDC also strictly controls the quality of the documents through the guidance. Not only does it strengthen domestic manufacturers’ understanding of MDR in the process, but also shortens the first phase of Notified-Body's timeline. Hopefully, when the related businesses face the requirements of MDR the process will be smoother in the future, and the quality of the domestic products sold in the international market will be more confident.