Successful Product Approval in Japan
Japan is one of the largest markets for medical devices in the world. However, obtaining product approval there poses a particular challenge for medical device manufacturers, due in part to the Japanese language and the complex approval process. In addition to the appointment of the Market Authorization Holder (MAH), this includes the registration of manufacturing sites and compliance with MHLW Ordinance No. 169. It is important to note that the approval process varies depending on the risk class of the medical device.
What makes our seminar unique?
In this interactive seminar, you will not only learn about the various requirements, but we will also use your products as examples to show you which approval process is right for you and how to navigate the approval process.
Numerous illustrative examples and practical tips will help you successfully obtain approval for your product in Japan.
- Content
- Regulatory and Legal Requirements
- Organization of the MHLW/PMDA
- Overview of the Legislation
- Market Authorization Holder (MAH)
- Access to the Japanese Market
- Product Classification
- Pre-market notification (Todokede)
- Pre-market certification (Ninsho)
- Pre-market approval (Shonin)
- Determining an appropriate approval procedure
- Japanese language requirements
- Quality management requirements: MHLW Ordinance No. 169
- Your Benefits
- You will learn about the various requirements for product approval in Japan.
- You will walk through the approval process for your specific product during the seminar.
- You will understand the structure of the regulatory authority (MHLW/PMDA) and know where to submit each application or registration.
- You will receive practical solutions tailored to your company.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- RA Specialists
- QM Specialists
- Medical device developers and manufacturers
- Project managers
- Medical device manufacturers and exporters
