엠디웍스코리아

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 Material

Reimbursement Appraisal Process

MFDS Approval

Pricing Guideline

Value Appraisal

‘Value Appraisal’ is to recognize premium value of innovative medical devices on the reimbursement price. For the value appraisal, the submission of clinical usefulness
documents (e.g., clinical evidence or technological and functional evidence, etc.) is mandatory.
The evidence should include comparison data which shows improvement of the device applied to the Value Appraisal process. 10% to 100%
can be recognized through Value Appraisal.

The value appraisal has two tracks according to the required types of evidence to prove the clinical usefulness:
Track A (Value Appraisal for Innovation) and Track B (Value Appraisal for Technical Improvement) Track A (Value Appraisal for Innovation) requires clinical evidence and make evaluation
with the ‘clinical usefulness A’ standard. The eligible premium ratio is 10% to 100%. Track B (Value Appraisal for Technical Improvement) requires technical and
functional evidence and make evaluation with the ‘Clinical usefulness B’ standard. The eligible premium ratio is 10% to 50%.