[Asia Economy Reporter Suyeon Woo] The Korea International Trade Association FTA Comprehensive Support Center held an online special lecture on the 16th titled "Acquisition of Overseas Medical Device Certifications and Basic Intellectual Property Education."
In the special lecture, Deputy Manager Ko Young-jae of the FTA Comprehensive Support Center presented on the support projects for non-tariff measures. Following this, Senior Researchers Ko Hyung-seung and Noh Sang-il of the Korea Testing & Research Institute (KTR) guided attendees on how to obtain medical device certifications in Latin America, Southeast Asia, and Europe. Then, Patent Attorney Park Sung-joon from the patent firm Iroomlion lectured on domestic and international patent and trademark application methods.
Senior Researcher Ko stated, "To distribute medical devices in Brazil, registration with the Brazilian Health Regulatory Agency (ANVISA) is mandatory, and only local companies holding a medical device business license can apply for this." He added, "For some medical devices, INMETRO certification must be obtained before applying to ANVISA, so thorough preliminary investigation is necessary."
Senior Researcher Noh explained, "Since May, the European medical device certification system has changed from the previous 'MDD (Medical Device Directive)' to 'MDR (Medical Device Regulation),' which means the directive has been elevated to a regulation." He further noted, "Because additional requirements such as separate clinical trials, regular report submissions, and post-market surveillance have been added, more detailed preparation is required."
Patent Attorney Park emphasized, "An agent is essential during the patent application process, and the agent also plays a crucial role in responding to patent infringement disputes." He added, "According to the principle of patent independence, patents must be applied for in each country separately," and explained the role of agents and the international application process in patents.
Meanwhile, the special lecture can be rewatched on the Trade Association's YouTube channel, and inquiries about the non-tariff support projects of the FTA Comprehensive Support Center can be made by phone (without area code, 1380) or through the FTA Integrated Platform.
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