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Taiwan Implements New Medical Devices Act

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Deputy Director at Food and Drug Administration, Ministry of Health and Welfare announced that the Medical Devices Act which has been designed to ensure that medical devices firms will have sufficient time to make appropriate adjustment as well as allow the government to have enough time to draft the relevant regulations. The Medical Devices Act will establish a system to effectively regulate medical devices throughout the medical device life cycle, marking a new start for medical device management in Taiwan and is in effect from May 1 of this year.

Following world trends, Taiwan has amended its Pharmaceutical Affairs Act and stipulated a new law specifically for the management of medical devices. With the Medical Devices Act in place, Taiwan could establish an appropriate management system that considers the characteristics of medical devices.

The new act covers repair and maintenance of medical devices, sale and supply of medical devices, quality management system and distribution management of medical devices. It also covers an electronic listing system for some low-risk products, the flexible validity period for issuing licenses, medical device clinical trials, safety monitoring of medical devices, proactive reporting and more. This Act aims to protect consumer safety and improve the management of medical devices.

According to Taiwan Food and Drug Administration (TFDA), they completed the drafting of relevant regulations and regulatory orders related to the Medical Devices Act, including Regulations Governing the Classification of Medical Devices, Regulations Governing Issuance of Medical Device License, Listing, and Annual Declaration, Regulations of Medical Device Tracking Management, and Regulations for Management of Medical Devices Technicians.

The government has also introduced various measures to give medical device firms a reasonable transition period to make adjustments and to minimise the impact on the industry. Director-General of Taiwan FDA states that Taiwan’s medical device management system will continue to follow international trends. Taiwan will work to harmonise with international regulations and reduce regulatory barriers that Taiwanese medical device dealers face when they attempt to compete in the international market.

At the same time, Taiwan will also work to protect consumers’ safety when they use medical devices, promote the development of the medical device industry and enhance the competitiveness of medical device businesses in the international arena.

Taiwan’s FDA is responsible for activities related to imminent threats to human health or life. This includes detecting and responding to public health emergencies, continuing to address existing critical public health challenges, and managing recalls, including drug shortages, and outbreaks related to foodborne illness and infectious diseases. Other vital activities that will continue are surveillance of adverse event reports for issues that could cause human harm, the review of import entries to determine potential risks to human health, determining conduct for cause and surveillance inspections of regulated facilities, and criminal enforcement work and certain civil investigations.

The Medical Devices Ac is also in line with the mission of Taiwan’s Ministry of Health and Welfare. The Ministry pursues holistic healthcare, happiness, and the well-being of all people. They also seek to provide living environments that promote worry-free child-rearing, healthy development, and active ageing. At the same time, we offer social welfare benefits and policies that support health equity and social equality

To achieve the mission, the Ministry utilises technology to provide information to doctors for reference and offer health insurance information to the general public. To ensure medication safety and to improve the quality of care, the administration built the NHI MediCloud system. Doctors and pharmacists can use the system to check a patient’s medication records, operative reports, discharge summaries, etc.

The individual cloud service My Health Bank is also available for people to check their recent doctor visits and medication records as well as preventive healthcare information which allows them to better understand health condition and engage in self-health management.


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