In brief: Taiwan regulator releases draft guidances for medical device vigilance reporting

The Taiwan Food and Drug Administration (TFDA) published two draft guidance documents for public consultation on October 8, offering updated information on post-market surveillance and reporting procedures.

Draft guidances detail medical device vigilance reporting procedures

The first guidance, Medical Device Safety Surveillance Management Measures (links in Chinese), defines the requirements surrounding submission to the TFDA of Periodic Safety Update Reports (PSURs). These reports have generally been required for the first three years that a new device is on market in Taiwan.

A second guidance, Measures for Notification of Serious Adverse Events of Medical Devices, outlines updated adverse event reporting requirements and procedures, complete with corresponding timelines.

Interested parties have 60 days from the publication of the announcements to submit feedback or suggest amendments to the draft guidance documents. Contact information for the proper individuals within the TFDA is provided in each announcement.

More resources for medical device regulatory assistance in Taiwan:

• Medical device registration and approval in Taiwan
• Taiwan medical device regulatory strategy report
• Medical device vigilance reporting in Taiwan
• Whitepaper: TFDA medical device registration requirements