Export to Japan 6: Technical Regulations - Medical Devices

What should you know when entering medical devices and in-vitro diagnostic devices (MD/IVD) market in Japan?

Various EU products and services began to enjoy benefits from the EU-Japan Economic Partnership Agreement (EPA) which entered in force on 1 February 2019, and we are seeing a considerable increase of EU exports to Japan.  But yet many EU exporters, particularly small and medium-scaled enterprises (SMEs) perceive access to Japanese market difficult because of unfamiliar trade and business practices.

This is a series of online training which presents the latest market information available in 2020 and explain in practical terms the most important things that EU companies should know when exporting to Japan so that the benefits of free trade can become more widely available to EU exporters for the second year of the EU-Japan EPA.

The topic of this online session is ‘Technical Regulations – Medical Devices’.

The session is targeted to: EU companies, particularly SMEs in medical devices and in-vitro diagnostic devices (MD/IVD) sector where industrial cooperation, specialization and supply-chain integration are actively in progress between the EU and Japan.  The webinar provides updates on the current developments of Japanese technical regulations and import market in Japan.

Topics covered during this session:

In 30 minutes from your desk, you will understand:

1. Japanese MD/IVD Market
2. Japan’s Legal and Regulatory Environment – Reimbursement System, Reimbursement Price Control Mechanism, Quality Management System (QMS)
3. Market Entry – Licensing Requirements for Foreign Manufacturers/Exporters

Programme:

• Introduction
• Expert’s presentation
• Q&A Session

Registration deadline: 27 October 2020

Speaker: Chieko Nakabayashi
Moderator: Pauline Laloux, Business Support Coordinator, EU-Japan Centre
Organiser: EU-Japan Centre for Industrial Cooperation - Brussels Office

AFTER EVENT INFORMATION