Pasesa Product Sheet

Listing Results Pasesa Product Sheet

Frequently Asked Questions

• What is the approval process for medical devices in Taiwan?

  Taiwan TFDA Regulatory Approval Process for Medical Devices. All manufacturers planning to sell a medical device in the Taiwan need to register their product with the Taiwan Food and Drug Administration (TFDA). All classes of medical devices require pre-market approval prior to Taiwanese market entry.

• Is preclinical testing conducted outside Taiwan approved by the tfdA?

  Testing conducted outside Taiwan is usually accepted by the TFDA. (Class II devices approved for sale in the US and Europe qualify for a Simplified Application Route and do not require a review of preclinical testing results by the TFDA.)

• Why are Taiwan's Major medical facilities reducing work units?

  As a result, Taiwan’s major medical facilities worked to limit the size of work units, reducing them by as much as two-thirds. In other words, fewer staff members are responsible for fewer patients, although the ratio remains constant. This allows for greater control over the spread of infection while keeping treatment standards intact.

• What makes Taiwan's healthcare system so special?

  Finally, Taiwan has benefited greatly from the close coordination between its hospitals and central government. Within the country’s nationalised healthcare system, every citizen and resident is assigned a health card, embedded with a computer chip reflecting their identity and medical history.