Medical devices are classified into the following categories according to their function, intended use, operating instructions, and working principle.

Taiwan Medical Device Registration Process · Class I (Low Risk) · Class II (Medium Risk) · Class III (High Risk) · New (No predicate device previously approved by ...

The Taiwan FDA uses a three-tier, risk-based classification system for medical devices and IVDs, from Class I (lowest risk) to Class III (highest risk). How ...

Medical device are classified into the following classes according to their level of risks: Class I : Low risk Class II : Medium risk Class III : High risk

Application for the Classification of Medical Devices · No. Title. Date · 1. Announcement Regarding Items Not Regulated as Medical Devices. 2024-06-26 · 2.

25 мая 2024 г. · Risk-Based Classification System. Taiwan employs a risk-based classification system for medical devices that categorizes them into three main ...

Medical devices are also classified into Class I, Class II and Class III based on their risk level. Class II and Class III devices must have the approval of ...

15 янв. 2024 г. · Taiwan uses the International Medical Device Classification System (IMDRF) to categorize medical devices based on risk, intended use, duration ...

All classes of medical devices require pre-market approval prior to entering the Taiwanese market.