An Overview of Software as Medical Device
In this ever-changing generation, what was once envisioned as Software as a Medical Device (SaMD) is no longer just a concept and is progressively becoming a reality. SaMD primarily supports various medical activities within medical care institutions, including:
What are Real World Data and Real World Evidence?
The Real World Data, RWD, is the data collected in real healthcare environment, but not the data from the strictly controlled clinical trials. The sources of the RWD can include any data related to health status or healthcare processes routinely collected such as hospital electronic heath record, National Health Insurance Research Database, post-marketing surveillance information, and data from wearable devices.
Regulation Amendments for Reporting Serious Adverse Reactions of Medicaments
The regulations for reporting severe adverse reactions of medicaments are established according to Article 45-1 of the Pharmaceutical Affairs Act and have been in effect for 20 years. The Ministry of Health and Welfare now references requirements and standards from the United States, European Union, Japan, and other countries, and aligns with the implementation of the Medical Devices Management Act. As the original regulations in the Pharmaceutical Affairs Act no longer apply to medical devices, the regulations and their title have been revised to 'Regulations for Reporting Severe Adverse Reactions of Medicaments'. These amendments will comprehensively take effect on January 1, 2025. The following are the key points of amendments to the regulations.
Clinical trial application to the authority in Taiwan
For conducting clinical trials of pharmaceuticals or medical devices in Taiwan, it is necessary to submit the application to the Taiwan Food and Drug Administration (TFDA) except those classified as having no significant risk. In addition to TFDA approval, the clinical trial must also be submitted to the Institutional Review Board (IRB) of the trial institution. Clinical trials can only proceed after completing these submissions.
What is clinical trial monitoring?
The purpose of implementing monitoring during the clinical trial is to ensure quality operation and data as well as trial efficiency. Sponsors should develop a clinical trial monitoring plan based on the benefit and protection of the subjects, along with the accuracy and completeness of the data, to ensure that the trial is conducted under appropriate monitoring. The sponsor would appoint the Clinical Research Associate (CRA) and choose site monitoring, system remote monitoring, or both.
What is ISO and ISO 13485?
ISO is an independent international organization established in 1947 with a membership of 169 national standards bodies. ISO develops and publishes international standards. Until now, ISO has published over 20,000 international standards, covering technology, management, manufacture, etc. Each international standard will be updated and revised according to the current situation, and the year of publication will be added after the name of the guidelines. However, ISO is not responsible for institutional certification which external certification agencies perform.
