The Taiwan Food and Drug Administration (TFDA) requires medical device manufacturers to comply with a vigilance system for post-market monitoring and adverse event reporting.
Taiwan’s Pharmaceutical Affairs Act and the Regulations for Governing theReporting of Serious Adverse Event of Pharmaceuticals offer valuable information on terminology, timelines and other vigilance reporting requirements in Taiwan.
Companies that fail to accurately report adverse events could face severe financial penalties or criminal sentences. Ignorance is not an acceptable excuse for not implementing a vigilance system in Taiwan.
When are vigilance reports required in Taiwan?
The Medical device license holder is required to submit serious adverse events to the TFDA. Adverse events occurring in Taiwan must be reported if they lead or death, life-threatening illness or injury or any of the following scenarios:
- Permanent impairment of a body function or permanent dame to a body structure
- Congenital anomaly/birth defect
- Hospitalization or prolongation of an existing hospitalization
- A condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent impairment of a body structure.
Additionally, according to the Article 80 of the Act, a medical device which is deemed defective (or manufactured and imported without a license) must be recalled.
In addition to vigilance reporting, the TFDA requires that new medical devices undergo a surveillance period where Periodic Safety Update Reports (PSUR) must be submitted. The surveillance period is generally three years for new medical devices.
TFDA Medical Device Vigilance Reporting Process
Shown below are the basic steps you should follow in reporting an adverse event in Taiwan:
- Inform your Taiwan Agent and the TFDA that a reportable adverse event has occurred.
- Investigate the cause of the adverse event, determine if corrective action is necessary and report all findings to the TFDA.
- Add all reports, along with any correspondence with the TFDA to your Quality Management System records.
Need help with vigilance reporting?
We have established excellent relationships with Taiwanese officials and are very familiar with handling vigilance issues and incident reporting to the TFDA. Working with Emergo offers you the following benefits:
- If we act as your Taiwan Agent, we can submit adverse event reports and recall information on your behalf.
- Our in-depth knowledge of Taiwan’s medical device regulations ensures that your vigilance procedures will always be up-to-date.
- Our experienced consultants can help you determine when incidents are reportable and ensure that required reports are completed on time.
- We have experience assisting hundreds of manufacturers with post-market surveillance, TFDA registration and other regulatory consulting services.
Please contact us for more information on how we can assist you with medical device vigilance reporting for Taiwan.