What is NOT a Medical Device?
The following are not regulated as medical devices under the Medical Devices Act:
| Category | Governing law |
|---|---|
| Pharmaceuticals | Pharmaceutical Affairs Act |
| IVD devices | In Vitro Diagnostics Medical Devices Act |
| Cosmetics | Cosmetics Act |
| General health products | Health Functional Foods Act |
| General PPE | Industrial Safety & Health Act |
| Veterinary devices | Veterinary-related legislation |
Borderline productsβ
When a product's status is unclear, submit a product classification inquiry (λΆλ₯ λ―Όμ) to MFDS before investing in approval.
Common borderline areas: wellness apps/wearables, cosmetic-device combinations, drug-device combinations.