Practice & Study

1. When did Taiwan's Medical Device Act take effect, separating devices from the Pharmaceutical Affairs Act?

2. How many risk classes does Taiwan use to classify medical devices?

3. Under IEC 62304, what determines the depth of documentation and testing required?

4. Which standard is the foundational risk-management standard that IEC 62304 normatively references?

5. What is the single most important first step for a software vendor under Taiwan's medical-software rules?

6. Which is the modern HL7 standard, built on a RESTful API and resources, that Taiwan promotes as the official direction for health-data interoperability?

7. Which standard is used for medical imaging transmission and storage (e.g., CT/MRI/X-ray)?

8. What does the FDA's Predetermined Change Control Plan (PCCP) allow for AI/ML devices?

9. In Taiwan, what does the CADe/CADx guidance distinguish between?

10. Under EU MDR Annex VIII Rule 11, software providing information for diagnostic/therapeutic decisions is generally classified as at least which class?

11. Why did Taiwan choose an indigenous FHIR-conversion route rather than wholesale adoption of a system like Epic for nationwide EMR interoperability?

12. Which of these is the medical record exchange infrastructure where clinicians can retrieve another hospital's records from the past 6 months with patient consent?

13. Which roles in Taiwan's medtech sector most strongly gate on medical/life-science background rather than coding skill?

14. What was VeriSee DR (Acer Medical) notable as in Taiwan?

15. What does an SaMD vendor still need to establish even with no physical production line?

16. What does UDI (Unique Device Identification) primarily strengthen for medical devices?

17. Under Taiwan's PDPA, how is health/medical data categorized?

18. What is the most worthwhile head-start skill a non-medical software engineer can pre-learn to differentiate for healthcare back-end roles?

19. In the US FDA framework, which pathway demonstrates substantial equivalence to a marketed predicate and is the most common route for SaMD?

20. What is the main goal of NHIA's 'temporary payment' and 'regulatory sandbox' approaches for AI devices and DTx?