Nov 9, 2020

The Taiwan Food and Drug Administration (TFDA) announced (link in Chinese) the temporary suspension of on-site inspections of overseas medical device manufacturers for the duration of the COVID-19 pandemic. For manufacturers who were scheduled to receive an on-site inspection in 2020, a document review will be conducted instead, and the inspection fees will be refunded. The TFDA reserves the right in such cases to conduct follow-up on-site inspections when it becomes safe to do so.

New medical device manufacturer inspection applications and review of urgent cases

The TFDA will continue to accept new inspection applications, but on-site inspections and fee payments will both be postponed until after the pandemic has abated.

For urgent cases in which it is deemed unacceptable to postpone inspections, the manufacturer may submit a letter with supporting information justifying the need for an inspection; the TFDA will then decide on a case-by-case basis whether a document review will be sufficient. The agency again reserves the right to conduct follow-up on-site inspections after the fact.

Further resources for medical device regulatory assistance in Taiwan:

Author

  • Timothy Herr

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