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Medical Materials

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Definition of Medical Materials in National Health Insurance(NHI)

Consumable Items such as medical device or Quasi-drug used in medical treatment for NHI insured patients and should be approved by MFDS(Former KFDA) or by the relevant laws and authorized by Minister of Health and Welfare

Type of Medical Materials

- Disposable Medical materials, such as the artificial joint, stent, and etc which are prescribed by “Medical Device Act”
- Quasi-drugs which are prescribed by "Pharmaceutical Affairs Act" such as gauze, bandages and so on.
- Some items of manufactured goods (batteries, CD, etc.)

Listing of Medical Materials

System Negative List System
- All medical materials are classified as NHI covered service (Reimbursement) or NHI non-covered service (non-reimbursement)
Listing Application Apply within 30days from the date of MFDS approval by manufacturer or importer
Notification Public announcement by Minister of Health and Welfare

Reimbursement Appraisal Process

Medical Material related New Health technology

Pricing Guideline