Qualtech Consulting would like to invite you to our free online Webinar on the subject of “Japan Medical Device Registration”. Our event is scheduled to be held on September 17th (Friday), 2021.

Depending on your place of location, the webinar will start at:

- 10 am (Central European Summer Time),
- 4 pm (GMT+8) local time in Taiwan,
- 5 pm (GMT+9) local time in Japan.

By joining our Webinar, you will be thoroughly informed about the Japanese regulatory system. Therefore, shall this Webinar be of interest to you or one of your colleagues, please be sure to register for the event using the following
Sign-Up Link (limited seats available).

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Webinar Agenda:
Given the strong interest in the Japanese markets and various questions received from our clients and potential clients regarding the Japanese regulatory system, our Webinar will provide you with a comprehensive overview of Medical Device Registration in Japan. Some of the key aspects discussed during the event will be the following:
1. Key Players in the Japanese Regulatory System and the Necessary Licenses
2. Classifications of Medical Devices in Japan
3. Consultation Sessions with PMDA
4. The Medical Device Registration Process in Japan
5. Registration Timelines

Speaker Introduction:

  • Ms. Ayaka Minamoto – Japan Regulatory Affairs Consultant, Qualtech

Ayaka is one of Qualtech’s Japan registration experts with multiple years of experience. Located in Tokyo, Ayaka is supporting Qualtech’s clients with obtaining Foreign Manufacturing Accreditations, Quality Management Certificates, and Product Approvals with the Japanese authorities. Ayaka is further specialized in developing regulatory strategies for our clients, while also assisting in pre-market consultations with Japan’s PMDA and certification bodies.

  • Ms. May Huang – Team Leader of the Biotechnology Division, RA. Dept. Qualtech

May is one of Qualtech’s most Senior Team Leaders, having successfully assisted with over 100 medical devices’ regulatory approvals. Besides Japan registration, she is also thoroughly familiar with various other regulatory systems in Asia, such as Taiwan. In addition, May is particularly experienced as project coordinator for novel device submissions, while she is also Qualtech’s expert for the dentistry, orthopedics, and cardiovascular fields.