Regulatory submissions in CD-ROM format
Another announcement states that, due to restrictions on in-person meetings relating to the COVID-19 pandemic, submissions for medical device registration, modification, and renewals should now be submitted electronically in CD-ROM format. The announcement specifies that this requirement will end when the epidemic alert level III is lifted in Taiwan.
COVID-19 test kits may be marketed through EUA
On the subject of the pandemic, the TFDA announced that COVID-19 test kits, including antigen, antibody (quantitative and semi-quantitative), and nucleic acid-based tests, may be manufactured and imported into Taiwan through an Emergency Use Authorization (EUA). Specific requirements for each type of application are outlined in the annexes to the announcement, and the regulation on EUA is available to read here.
Updated guidance documents on pre-clinical testing of medical devices
The TFDA also published updated guidance documents on pre-clinical testing of the following devices: absorbable and non-absorbable sutures, orthopedic internal and external fixation devices, and spinal intervertebral body fixation orthosis and intervertebral body fusion devices. These guidelines specify the relevant pre-clinical data requirements, along with the corresponding test methods and standards to verify compliance of the device.
New guidance on AI/ML CADe software
Finally, a new TFDA guidance document deals with artificial intelligence/machine learning computer-aided detection (AI/ML CADe) software. The document provides directions to manufacturers of these devices regarding product technical characteristics, safety and function verification information, and clinical evidence requirements. The guidance notes that, with the AI/ML field advancing rapidly, it is likely to undergo updates in the future.
More medical device regulatory resources for Taiwan from Emergo by UL:
- Taiwan medical device registration and approval consulting
- Taiwan Agent in-country representation
- Taiwan medical device regulatory strategy report
- Taiwan medical device vigilance reporting
Related resources:
- Taiwan Food and Drug Administration
- Taiwan Medical Device Regulations
- Taiwan TFDA Approval Process for Medical Devices