Demystifying Swiss Authorized Representative Requirements

For the foreign manufacturers who want to place their products on the Swiss medical device market, it is necessary to appoint a Swiss Authorized Representative. However, an agreement must be ensured between the manufacturer and the Representative before the Representative’s appointment. Need of the Swiss Authorized Representative For the non-Swiss…
Read More

Important Guidelines for MDSAP

The MDSAP (Medical Device Single Audit Program) is a three-year-long audit cycle. These cycles can be listed down as follows: The Initial Audit Cycle Partial Surveillance Audit Complete Re-audit The Initial Audit Cycle The initial audit cycle is the first year audit cycle and is also known as “Initial Certification…
Read More