Determining 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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May 6, 2021 Medical Devices -
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.
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October 12, 2020 Food and Food Supplements, Regulatory Labeling, Regulatory AffairsOn August 12, 2020, the United States Food and Drug Administration (USFDA) released a final rule for the labeling of food products falling under the category of fermented and hydrolyzed food.
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May 6, 2020 Regulatory Affairs, Publishing & SubmissionsThe COVID-19 pandemic has disrupted all the industries across the world. To handle the situation carefully, certain proactive measures have already been rolled out. One among them is to properly sanitize the hands with over the counter available drugs such as Hand rubs and Hand Sanitizers.
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February 28, 2020 Regulatory Labeling, Regulatory AffairsThe pharmaceutical supply chains are highly complex, with multiple stakeholders like manufacturers, suppliers, technology providers, packaging partners, and retailers obliged to maintain the Regulatory standards for quality, safety, and procedural accuracy throughout the product lifecycle.
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February 28, 2020 Regulatory Artwork Services, Medical Devices, Regulatory Labeling, Regulatory AffairsTo ensure high standards of quality and safety for medical devices being produced or supplied, the European Union (EU) has released a new Medical Device Regulation (MDR) in May 2017. As the transition period for medical device manufacturers will come to an end from May 26th, 2021, organizations must relook at implementing compliant processes and procedures accordingly.