The requirements of nucleic acid test for COVID-19 during public health emergency: Current regulatory in Taiwan, Singapore, and the United States.

In mid-2022, the COVID-19 cases have reached close to 562 million, but its overall infection rate is hard to confirm. Even with effective vaccines, break-through infections with new variants occur, and safe and reliable testing still plays a critical role in isolation of infected individuals and in control of an outbreak of a COVID-19 pandemic. In response to this urgent need, the diagnostic tests for COVID-19 are rapidly evolving and improving these days.

A comparison study of Taiwan regulation and GHTF regulatory model on in vitro diagnostic medical devices.

In Taiwan, In Vitro Diagnostic Medical Device (IVD) is regulated as medical device since 1987, and the implementation of IVD registration was fully completed in 2005. The management system of IVD medical device is highly similar with a guidance 'The GHTF Regulatory Model' developed by Global Harmonization Task Force (GHTF) in 2011 for use of regulation development on medical devices. Area covered: In this study, the Regulatory Model developed by GHTF was compared with Taiwanese IVD management system and it has shown that these two regulatory frameworks are highly similar.

A study of medical device regulation management model in Asia.

Introduction: With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products in order to meet the immense needs from the aging population. However, medical devices are designed to maintain the health and safety of people, therefore, medical devices are undergoing rigorous management by competent health authorities in all countries. In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes.