Taiwan – Final exemption list, cybersecurity guidelines, COVID-19 measures and more (Update)

Final list of medical devices exempt from QMS certification requirements now available

In a significant development, the Taiwan Food and Drug Administration (TFDA) has published the final list of devices (links in Chinese) exempt from Quality System Documentation (QSD) certification under the Medical Devices Act. This includes 125 Class I non-sterile devices, an increase from the 90 devices listed in the previous draft document as not needing to meet the agency’s quality management system (QMS) certification requirements. As we noted previously, the low number of devices on the draft list led to concerns that many hitherto exempt devices would require registration under the new regulation. The exemption list is effective as of July 16, 2021…