GLGlossary
Certification body / review body.
An organization designated to review technical documentation or quality systems on behalf of the MFDS.
The technical documentation review for Class II certification and KGMP reviews, among others, are in some cases carried out by a designated body rather than the MFDS. The fees paid to the body are incurred separately from the agency fee. Which body is involved can vary depending on the product type and procedure.
Related work & timing
Technical document review for Class 2 certification, KGMP conformity assessment, and similar procedures are carried out by designated institutions, and in such cases the review body's fees are incurred separately from our service fee.
Basis
- Enforcement Rule of the Medical Devices ActView source →
- Regulation on the Designation and Operation of Technical Document Review Bodies for Medical Devices (MFDS Notification)
The references shown are for guidance; confirm the exact, current requirements against the source text and through consultation.
The definitions on this page are general information. For an accurate judgment on a specific product or matter, please confirm through consultation.