The Health Ministry of Thailand strives to maintain the optimum quality of life and takes all the necessary measures to assure the health and safety of its people. Recently, the TFDA has amended the medical device regulations to meet the highest safety standards and quality of devices entering the Thailand market.
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August 31, 2021 Medical Devices -
August 26, 2021 Regulatory LabelingCommunication effectiveness across the marketing platforms is evaluated primarily based on how well the content engages the audience or, in the case of brands, the consumer. In healthcare, the information available on these platforms is diverse.
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July 27, 2021 Medical DevicesLabeling has paramount importance in the medical device industry for ensuring high standards of quality and safety. The labels help educate the end-users or patients about how to use the device, who should use it, how to operate the device safely and what risks it could pose.
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July 13, 2021 Medical DevicesIt is well known that the mandatory deadline for European Medical Device Regulation (EU MDR) was postponed to May 26, 2021, due to abrupt onset of COVID-19.
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May 6, 2021 Medical DevicesDetermining and setting up a quality system is a challenging task for medical devices manufacturers. A robust quality system covers the aspects like the medical device design, manufacturing, supplier management, product labeling, storage & distribution, clinical data, risk management and complaint handling.
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February 8, 2021 Medical Devices, Regulatory AffairsWith the EU MDR (European Union Medical Device Regulation) deadline inching closer on May 26th, 2021, it is necessary for the device industry to be aware of the EU MDR 2017/745 regulation for Economic Operators (EOs). As per the regulation, a Manufacturer, an Importer, a Distributor, and an Authorized Representative (AR) are considered as Economic Operators (EOs).
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December 21, 2020 Medical Devices, Regulatory AffairsAs the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance.
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December 9, 2020 Medical Devices, Regulatory Affairs, Regulatory Labelinge-labeling plays a critical role in the medical devices industry, as it ensures to improve operational efficiency, maintain brand consistency, obtain compliance and support business growth. Hence, the device industry is moving towards adopting end-to-end e-labeling life cycle procedures, starting from label content creation to review and approvals.
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October 22, 2020 Regulatory Labeling, Regulatory AffairsOn July 16, 2020, Japan’s Consumer Affairs Agency (CAA) revised the labeling standards for food products in the country. To do so, the CAA appointed a study group to discuss the current labeling system and make necessary changes in it. These changes aim to strengthen the labeling standards for food products in Japan, while streamlining their safe distribution.
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October 22, 2020 Food and Food Supplements, Regulatory Labeling, Regulatory AffairsTo strengthen the safety of food supplements in South Korea, in July 2020, the Ministry of Food and Drug Safety (MFDS) proposed to add “Precautions for Use” warnings to the label of food products. The proposed changes are applicable to food products with nine categories of ingredients.