Key Regulations for Medical Device Registration
- Regulations for the Supervision and Administration of Medical Devices (Order No. 276, Effective Date: April 1, 2000)
- Provisions for the Administration of Medical Device Registration (Order No.16, Effective Date: Aug 9, 2004)
- Provisions for the Administration of Instruction, Labeling and Package Mark of Medical Device (Order No.10, Effective Date: Jul.8, 2004)
- Provisions on Clinical Trial of Medical Devices (Order No.5, Effective Date: Jan 17, 2004)

Key Regulations for IVD reagent Registration
- Management Method of IVD Registration (Interim) (Directive 2007 No. 229, Effective Date: Jun.1, 2007)
- Guidance on clinical trial for IVD products (Effective Date: Jun 1, 2007)
- Guidance on insert composition for IVD products (Effective Date: Jun 1, 2007)