When it comes to the approval of medical devices, one is confronted with an increasingly complex regulatory world. The certificate course should help to internalize the basic concepts and working methods in regulation and to deepen them further using selected countries.

target group

Employees from the areas of regulatory affairs and quality management, those responsible for the first placing on the market, employees who are responsible for compliance with national and international legal regulations.

Topic overview & dates

Basics of Regulatory Affairs international (online)
July 9th/10th, 2024 Approval process in the USA (2 days) (hybrid)
09/11/2024 Approval procedure in China and Japan (hybrid)
09/26/2024 Approval procedures in Brazil, Mexico, Canada and Australia (hybrid)
10/10/2024 Approval procedures in Taiwan, Hong Kong and India (hybrid)
October 23, 2024 Approval procedures in Malaysia, Singapore, Thailand, Indonesia, Vietnam and the Philippines (ASEAN) (hybrid)
11/07/2024 Approval procedures in South Korea, Saudi Arabia, Israel and Turkey (online)
11/28/2024 Approval procedure in Great Britain and Switzerland (hybrid)

exam and graduation

After the course, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After passing the exam, the participants receive a certificate issued by MedicalMountains GmbH.


If you also attend module 1 of the "Regulatory Affairs Manager" certificate course, you will receive a certificate for both the "Regulatory Affairs Manager" and the "International Approval Manager" after passing the exam.

You can use the following link to book module 1 of the "Regulatory Affairs Manager" certificate course:

Regulatory Affairs Manager Module 1

Funding Opportunity

Tuttlingen & Online


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