The Research & Consulting Division of SunFlare Co., Ltd. participated in an exhibition held alongside the 2018 Special Regular Meeting of the Medical Device Industry Forum. This meeting, which included a seminar focused on promoting entry into the medical device industry, was hosted by the Osaka Chamber of Commerce and Industry on August 24, 2018. Both the seminar and the exhibition were attended by a wide variety of people, including company representatives and businesspersons aiming to enter or expand into the medical device field.

SunFlare is a leading provider of consulting services related to regulatory compliance, which is a prerequisite for entry into the medical device industry. At our booth, we provided an overview of these services, focusing mainly on the following themes: assistance for the acquisition of a license as a marketing authorization holder (MAH), a manufacturer, a distributor, a leasing business, or a repair business for medical devices; assistance related to regulatory affairs; consulting services related to the establishment of a quality management system (QMS) or a good vigilance practice (GVP) system; and assistance for the acquisition of ISO 13485 certification. Consultation meetings were available on request.

We also presented information on other key elements of our comprehensive range of services, including those related to helping to ensure regulatory compliance in Japan, acquiring European CE marking (assistance for entry into the EU market), conducting investigations related to legislation and standards, providing translation services, and selling sample Japanese translations of overseas legislation and guidelines for medical devices.

We would like to express our gratitude to everyone who visited our booth.

Event details
Title: Seminar on Entering the Medical Device Industry, organized as part of the 2018 Special Regular Meeting of the Medical Device Industry Forum
Date and time: 13:00 to 17:00 on August 24, 2018
Venue: Osaka Chamber of Commerce and Industry
Exhibiting companies: SunFlare Co., Ltd. and four other companies

Website of the Osaka Chamber of Commerce and Industry (in Japanese): Seminar on Entering the Medical Device Industry (2018 Special Regular Meeting of the Medical Device Industry Forum)
http://www.osaka.cci.or.jp/event/seminar/201807/D23180824013.html

Contact details for more information about this event:
Yuki Kurokawa or Shinya Arikawa
Research & Consulting Division
SunFlare Co., Ltd.
E-mail: info@sunflare.co.jp