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Newsletter.
Regulatory developments in medical devices and IVDs,
market updates and insights from BCG
Non-Conformity Findings in Medical Device KGMP Audits
A KGMP audit may result in a non-conformity decision where a violation of Korea's Medical Devices Act is identified. Common examples include:
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…
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