Planning to import N95, N99 or other face masks into the United States? In this guide, we cover the basics of face mask and respirator standards, FDA requirements, labeling requirements, lab testing, and more.
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Continue reading Face Mask Regulations and Standards in the United States: An Overview
Planning to import medical or protective face masks to the European Union? In this guide, we cover product regulations, EN standards, labeling, certification, and lab testing requirements when importing or manufacturing various types of face masks for the EU.
Mentioned Products
Continue reading Face Mask Regulations and Standards in the EU: An Overview
Face masks, medical gloves, and other medical devices are regulated by the Medical Devices Directive in the European Union. The scope of the Medical Devices Directive covers safety standards, labeling, quality management systems, product registration, and documentation. Further, some medical devices are more strictly regulated than others.
In this guide, written by Anssi Ilmari Tynjälä from Innovapro, you will learn what it takes for importers and manufacturers to ensure compliance with the Medical Devices Directive. Continue reading EU Medical Devices Directive Guide: By Anssi Ilmari Tynjälä
The Radio Equipment Directive (RED) applies to all Wi-Fi, Bluetooth, LTE, 5G, GPS and other radio-electric enabled devices sold in the European Union. In this guide, we cover the basics of RED requirements for smartphones, smartwatches, computers and other electronic products. Continue reading List of Products Covered by the Radio Equipment Directive (RED)
In this article, we list products covered by one or more FDA rules or regulations. FDA regulations cover a wide range of products, including food contact materials, medical devices, sunglasses, supplement and more.
Note: This article also lists some FDA regulations/rules applicable to certain product categories. Notice that the lists are not definitive or kept up to date. Continue reading List of Products Covered by US FDA Regulations
Planning to import and sell prescription glasses, medical gloves, thermometres or other related medical products in the European Union? If so, chances are that you must ensure compliance with the Medical Devices Directive. In this guide, we list both exemptions and products covered by the scope of the Medical Devices Directive. Continue reading List of Products Covered by the EU Medical Devices Directive
Trying to figure out if your product is covered by Machinery Directive (MD) 2006/42/EC? In this article, we list E-bikes, electronic gym machinery, electronic gym machines and other products that fall within the scope of Machinery Directive. Continue reading List of Products Covered by the EU Machinery Directive
FCC Part 15 regulates most electronic products sold in the United States. In this guide, we list electronic products classified as either intentional or unintentional radiators by FCC Part 15. We also list products exempt from the regualtion. Continue reading List of Products Covered by FCC Part 15
The EU Food Contact Materials Framework Regulation 1935/2004 covers plastic, ceramic, metal and other food contact materials. In this guide, list kitchen appliances, food packaging, wooden composites and other products covered by the scope of the regulation. Continue reading List of Products Covered by the EU FCM Framework Regulation (No 1935/2004)
Planning to sell toys, children’s furniture or other children’s products in the European Union? If so, then compliance with the Toy Safety Directive is required. In this guide, we list products covered by the Toy Safety Directive, and some exemptions.
Continue reading List of Products Covered by the Toy Safety Directive and EN 71
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