Taiwan Medical Device Vigilance and Safety Reporting

Regulatory Oversight of the TFDA

The monitoring of medical device safety in Taiwan is governed by the Taiwan Food and Drug Administration, commonly referred to as the TFDA. Under the Pharmaceutical Affairs Act and the Regulations for Governing the Reporting of Serious Adverse Event of Pharmaceuticals, manufacturers must implement a robust vigilance system for post-market monitoring. Compliance is mandatory, and ignorance is not an acceptable excuse for failing to report incidents, which could lead to severe financial penalties or criminal sentences.

Criteria for Serious Adverse Event Reporting

The medical device license holder is legally obligated to notify the TFDA of adverse events occurring in Taiwan that lead to specific serious outcomes.

• Events resulting in death or life-threatening illness or injury must be disclosed.
• Permanent impairment of a body function or permanent damage to a body structure requires reporting.
• Incidents involving congenital anomalies or birth defects must be notified.
• Any scenario requiring hospitalization or the extension of an existing hospitalization must be reported.
• Situations necessitating medical or surgical intervention to prevent permanent body impairment or damage must also be disclosed.

Additionally, according to Article 80 of the Act, any medical device deemed defective or manufactured/imported without a valid license must be recalled.

Periodic Safety Update Reports (PSUR)

Beyond immediate incident reporting, the TFDA requires that new medical devices undergo a specific surveillance period. During this time, Periodic Safety Update Reports (PSUR) must be submitted to the authority. For new medical devices, this surveillance period generally lasts for three years.

TFDA Administrative Vigilance Reporting Process

The management of safety data in Taiwan follows a structured sequence of actions involving the manufacturer and their local representative.

• The Taiwan Agent and the TFDA must be informed as soon as a reportable adverse event has occurred.
• Manufacturers are required to investigate the root cause of the incident and determine if corrective action is necessary.
• All investigation findings and outcomes must be formally reported to the TFDA.
• All vigilance reports, along with any official correspondence with the TFDA, must be integrated into the company's Quality Management System records.

Role of the Taiwan Agent

For international manufacturers, the Taiwan Agent serves as the essential legal liaison with the TFDA. This entity is responsible for submitting adverse event reports and coordinating recall information on behalf of the manufacturer. The agent ensures that all reports are completed on time and that the manufacturer's vigilance procedures remain in alignment with the latest Taiwanese regulations.

Proregulations' Taiwan Vigilance Services

Our team facilitates compliance with TFDA post-market requirements through the following specialized service modules.

• Taiwan Agent and TFDA representation
  We act as your officially designated Taiwan Agent to manage mandatory safety notifications and handle all communications with the TFDA.
• Incident assessment and reportability analysis
  Our experts help determine when incidents meet the reporting criteria and ensure that the required notifications are submitted to the TFDA on time.
• PSUR preparation and surveillance support
  We assist in managing the three-year surveillance period for new devices by preparing and submitting the required Periodic Safety Update Reports.
• Recall management and regulatory coordination
  We help navigate the recall process for defective devices, ensuring that all actions comply with Article 80 of the Pharmaceutical Affairs Act.
• Quality system and documentation maintenance
  Our team ensures that all final safety reports and vigilance correspondence are properly recorded within your technical files to support future regulatory inspections.

If you are interested in our Taiwan medical device vigilance reporting services and wish to maintain your compliance with TFDA regulations, please feel free to contact us.