Tuttlingen - Medical technology "Made in Germany" enjoys an excellent reputation worldwide. An export rate of around 66 percent speaks for itself. Nevertheless, there are a few things to consider in order to be able to approve products outside the EU. This fall, four seminars will take you on a journey to the major medical technology markets and their specifications – around the world in five days.
Destination: United States
The market across the Atlantic is still number 1 for many companies. A "classic" for the industry, one might say - just like the two-day seminar in the program of MedicalMountains GmbH. It deepens complex relationships and, among other things, deals with different types of submissions and the formal requirements for a 510(k) file.
Check in: Seminar "Approval Processes for Medical Devices in the USA" on September 21st and 22nd
Destination: China, Japan, Taiwan
Entering the Asian market offers enormous opportunities for manufacturers - but not without risk. Knowing and understanding the mentality and national regulations is essential and can mean the difference between success and failure. The seminar examines the prerequisites and procedures and underpins the theory with case studies and field reports.
Check-in: Seminar "Approval Procedures for Medical Devices in China, Japan & Taiwan" on October 5th
Destination: Brazil, Mexico, Canada
Canada, Brazil and Mexico (among other countries) are emerging as promising consumer markets. As in the EU, the authorities there require various documents for approval. In the seminar, the participants get to know similarities and differences to the CE certification. You will also receive an overview of the documents to be submitted.
Check-in: Seminar “Approval Procedures for Medical Devices in Brazil, Mexico and Canada” on October 18th
Destination: Malaysia, Singapore (ASEAN), Australia, South Korea, Russia, Saudi Arabia
The ASEAN countries, Australia, South Korea, Russia and Saudi Arabia are among the important destinations in medical technology. Before selling medical devices legally, however, manufacturers must demonstrate compliance with legal regulations. In this seminar, the participants learn which requirements must be met in the respective countries in order for medical products to be approved by the responsible authorities there. And they learn how to successfully create the necessary documentation for registration.
Check-in: Seminar “Approval Procedures for Medical Devices in Malaysia, Singapore (ASEAN), Australia, South Korea, Russia and Saudi Arabia” on November 8th
