Frequently Asked Questions.

A. The following are examples of commonly queried requirements for overseas test reports. For the full criteria, refer to the Korean Regulation on Medical Device Approval, Notification and Review.

1. Electrical & Mechanical Safety Data
   – Test reports issued by a National Certification Body (NCB) under the IEC's IECEE CB Scheme
   – Reports issued by laboratories accredited to ISO/IEC 17025 under the ILAC Mutual Recognition Arrangement (MRA), with a scope covering all applicable device standard tests
   – Reports meeting the above criteria may be accepted.
2. Biological Safety Data
   – Non-clinical test data from facilities in OECD member countries that comply with OECD Good Laboratory Practice (GLP), or in non-member countries recognised by the OECD as meeting these requirements
   – Reports from facilities that do not meet the above OECD GLP recognition criteria cannot be accepted under this route.