Mastering Medical Device Approval in Thriving Asian Markets:
Free Webinar for Successful Market Entry
Projected as the world's fastest-growing economy, Asia offers European medical device manufacturers abundant opportunities to grow their business, enhance competitiveness, and explore new profit streams.
However, navigating international medical device approval processes can appear intimidating. Perceived complexities and country-specific requirements, including language barriers, often discourage manufacturers from seizing these opportunities.
With this webinar, we want to show you that this journey is manageable, and the rewards can be substantial.
Choosing the right markets:
Invest your time and energy wisely
In this webinar, our international regulatory affairs experts will show you the opportunities and trends that have emerged in Asia, guiding you to markets where the effort of international approval is worth the investment. They will also highlight potential challenges and risks specific to these markets.
Planning with confidence:
Know your actions, timeline, and costs
This webinar is designed to offer you a first roadmap for successful international approval in Asia. We will walk you through the general regulatory requirements, necessary documentation, and the competent authorities for five relevant markets – discussing current harmonization efforts and possible synergy effects along the way.
Reliable partners at your side:
Comprehensive support from local experts
We will introduce our local partners from various countries who can assist you with on-site approvals. They can help you with the registration process and communication with the competent authorities. Our partners are trustworthy and proven: together, we have accomplished numerous projects.
Meet your lecturers
Margret Seidenfaden supports the Johner Institute's clients in matters concerning international requirements for medical devices and product approval. She studied medical engineering and business administration and focused on quality management and regulatory affairs early in her career. Her passion is dedicated to diverse regulatory issues related to medical devices and helping manufacturers in overcoming challenges in international market approval processes. Before joining the Johner Institute in 2020, she was responsible for the planning, implementation, and monitoring of worldwide product registrations.
After her graduation in Biomedical Engineering and her studies of Regulatory Affairs Management, Katharina Keutgen worked many years in the development and regulatory affairs management of heart-lung machines and vascular access devices, where she acquired extensive regulatory expertise. As a member of the Medical Device Team, she has been supporting the Johner Institute's clients with international approvals and questions relating to the regulatory strategy of medical devices since 2021 and conducts seminars and workshops on the topic of UDI and US FDA.
