Test Items
GLP-Designated Items for Pharmaceuticals (Nonclinical Test Facility)
General Toxicity Tests
- Single-Dose Toxicity Test (rodents, non-rodents)
- Repeated-Dose Toxicity Test (rodents, non-rodents)
In Vitro / In Vivo Genotoxicity Tests
- Reverse Mutation Test
- Chromosomal Aberration Test
- Micronucleus Test
Local Toxicity Tests
- Skin Irritation Test
- Ocular Mucosa Irritation Test
GLP-Designated Items for Medical Devices (Nonclinical Test Facility)
In Vitro / In Vivo Genotoxicity Tests
- Reverse Mutation Test
- Chromosomal Aberration Test
- Micronucleus Test
Hemocompatibility Test
- In Vitro Test (Hemolysis Test)
Cytotoxicity Tests
- Extract Test
- Test by Indirect Contact
Implantation Tests
- Subcutaneous Tissue Implantation Test
- Intramuscular Implantation Test
- Bone Tissue Implantation Test
Irritation and Skin Sensitization Tests
- Intracutaneous Reactivity Test
- Oral Mucosa Irritation Test
- Guinea Pig Test for Skin Sensitization Detection
Systemic Toxicity Tests
- Acute Systemic Toxicity Test
- Repeated-Exposure Systemic Toxicity Test (subacute/subchronic)
- Pyrogenicity Test (material-mediated)
Inspection-Target Item Categories of the Medical Device Testing & Inspection Institution
Items in the following 11 item categories.
| Item Category | Exclusions or Limitations |
|---|---|
| Procedural Instruments & Devices | Excluding cardiovascular instruments and urological instruments |
| Biophysiological Measurement Devices | Limited to medical probes and measuring & guiding instruments |
| Medical Treatment Instruments & Devices | Excluding medical washers, dental engines, and medical inhalers |
| Syringes & Needles | Excluding acupuncture or moxibustion instruments |
| Dental Treatment Instruments & Devices | Limited to dental broaches, dental probes, dental dams, and impression-taking & occlusion instruments |
| Implantable Medical Supplies | - |
| Human Tissue or Functional Substitutes | - |
| External Medical Supplies | Excluding splints |
| Contraceptive Devices | - |
| Dental Alloys | - |
| Dental Treatment Materials | - |
Efficacy Evaluation Tests
- Anticancer Drug Efficacy Evaluation
- Bone Regeneration Efficacy Evaluation
- Liver Cirrhosis Regeneration Efficacy Evaluation
- Corneal Regeneration Efficacy Evaluation
- Renal Failure Regeneration Efficacy Evaluation
- Other Efficacy Evaluations Using Animal Models (available through consultation)
Other
- Internal Research Support (experiment support and specimen analysis services)
- Consultation on the Development and Approval Process of Pharmaceuticals and Medical Devices