The Taiwan Food and Drug Administration (FDA) has published several draft guidance documents dedicated to the post-market activities related to medical devices marketed in Taiwan. In particular, the documents are covering the aspects related to the adverse events reporting and surveillance, describing the obligations of the medical device manufacturers and other parties involved in operations with medical devices, and also the mandatory requirements to be followed to ensure the safety of patients.

Adverse Event Reporting Basics

The first document issued by the Taiwan FDA constitutes draft guidance on adverse events reporting for medical devices. The document describes the measures to be taken by the medical device manufacturers, suppliers, or healthcare institutions in case of any adverse events associated with medical devices being identified when used for the intended purpose. In particular, the guidance outlines the way such events should be reported to the state authorities responsible for state control and supervision of the sphere of medical devices. According to the document, any and all adverse events resulting in significant harm caused to the health of the patient should be duly reported. The scope of events subject to reporting also includes the cases when the patient requires hospitalization and treatment to mitigate the consequences of the effects caused by a medical device. 

In accordance with the guidelines, the adverse event report should be submitted as an Internet-notification. However, if due to some reasons it is impossible, a party that becomes aware of the adverse event shall submit the report in a paper form or via email.

The adverse event report should contain the following information: 

  1. Name, address of the manufacturer, as well as the name and contact details of the particular person submitting the report. 
  2. Date of the incident and basic information.
  3. The Chinese name of the product and information about the license (number or code).
  4. Model and/or batch of a medical device.
  5. Source of supply and supply chain in general. 
  6. Description of the situation the adverse event occurred. 
  7. Types and results of negative effects. 
  8. Description of the way the adverse event occurred, including the site (place), side effects symptoms, reasons, and malfunctions that could potentially lead to the adverse event, and also the further treatment of injured patients.

Adverse Event Reporting Obligations and Responsibilities 

The healthcare institution that faced adverse events associated with the medical devices shall duly submit the report in the appropriate term to be determined depending on the severity of consequences, supplementing the report with detailed information about the supplier of a medical device. 

Due to the important role of the medical device manufacturer in ensuring safety and performance, the manufacturer has a significantly wider range of responsibilities. In accordance with the draft guidance, the license holder shall be also responsible for the safety preventive and corrective actions to be taken to mintage the risks associated with the medical device, including the corresponding obligation to report upon completion of such actions. In case if due to the nature of the adverse events special preventive measures are required, the manufacturer shall also duly inform the distributors and healthcare institutions. 

In order to comply with the applicable requirements, all parties involved are obliged to document the incident-relating information. All documents related to adverse events associated with medical devices should be kept for at least 5 years. Such documents should be also provided to the regulating authorities upon the appropriate request within the term specified therein. The Taiwan FDA additionally emphasizes that the reporting entity may not refuse to provide the documents or any information related to adverse events or incidents associated with medical devices, including the information about the patents.

The suppliers and distributors of medical devices should also establish an efficient reporting system in order to ensure fast and efficient transmission of the incident-related information and notifications. The appropriate measures include proper collection and storing of the information, providing that compliance with the applicable regulations on personal data protection should be ensured. 

Adverse Event Report Template 

Besides the general requirements and obligations of the parties involved, the Taiwan draft guidance on adverse event reporting also contains a template of the report to be used to submit the information about the incident associated with the medical device to the appropriate state authority. According to the template, the report should consist of the following sections:

  1. General information (basic information about the report itself, including the source of information about the incident, the date of first notification, and also the estimated date of the follow-up report).
  2. Information about the patients, including the age or date of birth, weight, height, and other important parameters.
  3. Information about the medical device in question including, inter alia, the details of the license holder, model, software (if applicable), manufacturing date, UDI and GMDN details, class of the device under the risk-based classification, the indication of whether the device is a single-use or a multiple-use product, and also the country of origin. This section should also contain the information about the supplier of the device and the current status of the device (e.g. «destroyed», «under investigation», «returned to the manufacturer», or «still implanted»). 
  4. Information about the adverse event, including its category and consequences. This section covers the classification of the problem related to the product (e.g. «ecological issues», «physical characteristics», «use-related (compatibility) matters»), and also the indication of whether the problem occurred during the first use of the device, one of the following uses, or after the repairmen. The information about the operator of the device (e.g. «healthcare professional» or «patient») should be also provided in this section. In order to ensure that all information that is necessary to assess the case is included, this section should also contain the details about any products used simultaneously, as well as about the use environment, conditions, and also the appropriate checks conducted before the use. 
  5. Incident investigations data (to be filled in by the supplier of a medical device). This section should contain a brief summary of the evaluation of a medical device in question, while the complete evaluation report should be provided in the attachment. The information shall also contain the references to the applicable standards used in the course of the evaluation. According to the guidelines, the results of the investigation of the incident itself should be also provided in this section, together with the complete investigation report. In case if the investigation was not commenced, the appropriate justification should be provided. It is important to mention that this section should also contain the code of the adverse event in accordance with the harmonized incident codification system developed by the International Medical Device Regulators Forum (IMDRF). Moreover, this section should also describe the frequency of the incidents occurring, as well as the indication of the corrective and preventive measures to be taken to mitigate the risks associated with the medical device.

Summarizing the information provided herein, the guidance on adverse event reporting, published by the Taiwan FDA, describes the most important obligations of the parties involved in operations with medical devices and also outlines the information to be included in the adverse event report. 

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