Are you planning to import, export, or manufacture medical devices in the United States? In this guide, we introduce you to lab testing requirements, classification, device registration, labeling, GMP and premarket submissions.
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Continue reading FDA Regulations For Medical Devices: An Overview
Planning to import and sell electronic products in Australia? In this guide, we introduce you to relevant AS/NZS standards, general safety requirements, Electrical Equipment Safety Scheme (EESS), ACMA rules, the Regulatory Compliance Mark, and much more. Continue reading Electronic Product Standards and Regulations in Australia: An Overview
Planning to import or manufacture helmets in the United States? In this article, we will explain both mandatory and voluntary requirements for different types of helmets, including CPSC, OHS Act, ANSI standards, and more. Continue reading Helmet Safety Standards in the United States: An Overview
Planning to import and sell clothing, electronics, toys, or other consumer products in Australia? In this guide, we explain what all importers and exporters must know about Australian product labeling requirements – including manufacturer information, packaging, statements, and more.
The Australia Border Force requires certain goods to be labeled before being imported to Australia, including information such as product description, manufacturer information, packaging information, and other statements. Continue reading Product Labeling Requirements in Australia: An Overview
Planning to import and sell furniture in Australia? In this guide, we explain the basics of furniture regulations in Australia, including AS/NZS standards, safety requirements, labeling, and much more.
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Continue reading Furniture Standards and Regulations in Australia: An Overview
Product compliance can be expensive. Consultants and lab testing services can cost thousands of dollars. As such, suppliers have an incentive to cut corners by either creating or buying fake lab test reports and product certificates – for a fraction of what it would cost to do it the right way.
As I write this, we’re in the midst of an enormous medical supplies gold rush. Suppliers and buyers alike are desperate the capitalize on the only booming industry in existence today.
We do a lot of supplier screenings involving document checks. Never before have I seen so many bogus test reports, “CE certificates” and other deceptive documents. That being said, I’ve dealt with this problem for almost ten years now – so it’s certainly not new. Continue reading Fake Product Certificates and Test Reports: An Essential Guide
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
Both wireless and wired earphones are covered by various standards and regulations in the United States. In this guide, we cover the basics of FCC Part 15, UL standards, labeling requirements and regulations covering chemicals and heavy metals.
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Continue reading Earphones Safety Standards in the United States: An Overview
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
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
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