Interpreting Requirements for Medical Device KGMP Audits.

KGMP conformity assessments are official duties performed on behalf of the Minister of Food and Drug Safety, rather than private assessments, and are conducted in Korean.

Manufacturers/importers should arrange an interpreter able to understand the language used at the site and interpret directly into Korean.

Interpreting is particularly important in non-English-speaking countries, so preparation should be completed thoroughly before the audit.

Relay interpreting, for example German → English → Korean, may extend the audit duration. Qualified interpreters should therefore be available.

An auditor may stop the assessment if interpreting problems make it difficult or impossible to continue.

Contact BCG to arrange experienced interpreters for medical device KGMP audits.