The Research & Consulting Division of SunFlare Co., Ltd. hosted an exhibition booth at Medtec Japan 2018. The largest exhibition and seminar in Asia that is related to the design and manufacture of medical devices, this event was held from April 18 to April 20, 2018. A summary of our participation in the event is provided below.

SunFlare Co., Ltd. has hosted an exhibition booth at this event every year since 2013, so this year marked our sixth year of attendance. At our exhibition booth, we provided visitors with free consultations and an introduction to the services that we provide in relation to regulatory affairs for medical devices. Many of the consultations that we provided covered the topics listed below.

Main consultation topics
〇 Assistance related to the acquisition of European CE marking certification
Formulation of plans for transitioning to the Medical Device Regulation (MDR), explanation of MDR requirements, drafting of technical files and clinical evaluation reports, assistance in ensuring compliance with standards (including EN 62304 and EN 62366), etc.

〇 Investigation of laws and regulations and analysis of client's current compliance with standards
Investigation of laws and regulations for medical devices in various countries, investigation of standards and requirements applicable to the relevant product, analysis of differences between ISO 13485 and quality management system (QMS) standards in different countries, etc.

〇 Assistance related to the acquisition of ISO 13485 certification
Identification of requirements, analysis to determine whether the current QMS is compliant, establishment of a QMS system and drafting of QMS-related documents, assistance in operating and maintaining a QMS, etc.

〇Assistance related to design and development and compliance with standards
Detailed lectures on risk management (ISO 14971), assistance in ensuring compliance with standards related to the safety of medical electrical equipment (e.g., IEC 60601-1 Edition 3.1), assistance in ensuring compliance with Paragraph 2 of Article 12 in the new basic requirements (IEC 62304/JIS T 2304), etc.

〇 Assistance related to compliance with Japan's regulatory system
Assistance in establishing, operating and maintaining a QMS, regulatory affairs (including strategic decisions), post-marketing actions, etc.

〇 Assistance related to entering the medical device industry
Conducting of roadmap investigations, establishment of a QMS or a good vigilance practice (GVP) system, acquisition of business licenses, regulatory affairs, human resource development, etc., with the aim of commercializing the relevant device.

We received many inquiries concerning topics such as regulatory affairs in Japan, ISO 13485, European CE marking, and compliance with the MDR and the In Vitro Diagnostic Medical Device Regulation (IVDR), making the three-day event a huge success. We would like to express our gratitude to everyone who visited our booth.

SunFlare will continue to participate in exhibitions and propose client solutions as we seek to contribute to further success in the medical device industry. We appreciate your continued support.

Event details
Title: Medtec Japan 2018
Sponsor: UBM Japan Co. Ltd.
Date and time: 10:00 to 17:00 on April 18 to April 20, 2018
Venue: East Exhibition Halls 4, 5 and 6 at Tokyo Big Sight
Booth location: East Exhibition Hall 4 in Certification/Consultation Area 1215
No. of exhibiting companies/groups: 560
No. of visitors: 31,062
SunFlare's booth at Medtec Japan 2018