Program Description

Asia-Pacific Medical Device Regulatory Certificate

Estimated Learning Duration of the Program:
3-6 months
Program Description:

This program provides a country-by-country review of the regulatory, quality assurance, and clinical data requirements in the Asia-Pacific region, including product classification systems and market access procedures.

Please note that many Asia-Pacific countries require submissions in their national language; the courses in this program will provide local terminology where appropriate and useful. The courses will also explain when local representatives are needed and how these parties must comply with national requirements as a representative of the manufacturer.

Learning Objectives:

Upon successfully completing this program, learners will be able to:

  • Start market access activities in a given Asia-Pacific country or series of countries
  • Work with the appropriate local representative on market access files in an efficient manner

Price:€ 509.00

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