Mark your calendar for Thursday, September 04, 2025, as Qualtech hosts an in-depth regulatory webinar guiding you through the pathways required to bring your medical device into Japan and South Korea—two of Asia’s most advanced and high-potential healthcare markets.
For manufacturers expanding across Asia, a thorough understanding of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the Ministry of Food and Drug Safety (MFDS) in South Korea is critical to achieving timely approvals and ensuring compliance.
This webinar will provide valuable insights into:
Japan – Navigating PMDA's Regulatory Landscape:
- Overview of Japan’s regulatory structure and PMDA’s role
- Device classification system (Class I–IV)
- Registration pathways and expected review timelines
- Common challenges foreign manufacturers encounter
South Korea – Understanding MFDS Requirements:
- MFDS regulatory framework and classification rules
- Application process and required documentation
- Practical difficulties and key considerations for faster approval
Webinar Details
- Date: Thursday, September 04, 2025
- Time: 4PM (GMT +8) | 10AM (CEST)
- Language: English
- Registration Link: https://forms.gle/wabRwpmM6h5uCVf18
Whether you are initiating your market entry plans or refining an existing regulatory strategy, this webinar is an opportunity to learn from experts, avoid common pitfalls, and accelerate your entry into Japan and Korea's MedTech markets.
