[GMP Update] Combined Medical Device and IVD Audit Duration (April 2024).

Following implementation of Korea's In Vitro Diagnostic Medical Devices Act in 2020, MFDS stated that it provided guidance to avoid duplicate audits where the same quality system applies.

Sites manufacturing both medical devices and IVDs under the same QMS may undergo a combined on-site audit.

The QMS on-site audit uses the existing audit duration, while a separate IVD assessment is conducted through document review (1.2 auditor-days).

Application fees are charged separately for medical devices and IVDs.

Where additional on-site auditor-days are needed, the review body should agree on them with the company in advance and charge the corresponding fees.

The additional IVD on-site audit fee comprises: ① application fee + ② document review fee (0.6 auditor-days) + ③ fee for additional on-site auditor-days.

Contact BCG for further information.

https://emedi.mfds.go.kr/gmp/aply/view/MNU20284?&pstSno=13&bbsSno=1339