Fake Product Certificates and Test Reports: An Essential Guide

Posted on by Fredrik Gronkvist — 14 Comments

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

Face Mask Regulations and Standards in the United States: An Overview

Posted on by Vincent Cheng — 2 Comments

Face Mask Regulations United States

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.

Mentioned Products

  • 3-ply, 4-ply and 5-ply surgical masks
  • N95, N99, N100 masks or respirators
  • FFP1, FFP2, FFP3 masks and respirators
  • KN95 masks or respirators

Continue reading Face Mask Regulations and Standards in the United States: An Overview

Earphones Safety Standards in the United States: An Overview

Posted on by Chuiyan Mo — Leave a comment

Earphones Safety Standards United States

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.

Mentioned products

  • Wireless earphones
  • Wired earphones
  • Bluetooth earphones
  • Noise-canceling headphones
  • In-ear headsets

Continue reading Earphones Safety Standards in the United States: An Overview

Face Mask Regulations and Standards in the EU: An Overview

Posted on by Vincent Cheng — 15 Comments

Face Mask Regulations in the EU
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

  • 3-ply surgical face masks
  • 4-ply- surgical face masks
  • 5-ply surgical face masks
  • FFP1 mask or respirators
  • FFP2 masks or respirators
  • N95 masks or respirators
  • FFP3 masks or respirators
  • N99 masks or respirators

Continue reading Face Mask Regulations and Standards in the EU: An Overview

EU Medical Devices Directive Guide: By Anssi Ilmari Tynjälä

Posted on by Fredrik Gronkvist — Leave a comment

Medical Devices Directive

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

Earphones Safety Standards in the European Union: An Overview

Posted on by Chuiyan Mo — 1 Comment

Earphones Safety Standards European Union
Earphones imported or manufactured in the EU must comply with regulations, such as RoHS, REACH and the Radio Equipment Directive. In this guide, we list relevant EU standards, regulations, certification and labeling requirements for both wired and wireless earphones.

Mentioned products

  • Earbuds
  • Headsets
  • Noise-canceling earphones
  • Bluetooth earphones
  • Wireless earphones
  • Wired earphones

Continue reading Earphones Safety Standards in the European Union: An Overview

Helmet Safety Standards in the European Union: An Overview

Posted on by Vincent Cheng — 5 Comments

Helmets Safety Standards European Union
Helmets of various kinds are normally classified as Personal Protective Equipment in the European Union. In this guide, we cover the PPE Directive, EN standards, REACH, certification, labeling and other requirements when importing or exporting helmets to the EU.

Mentioned Products

  • Bicycle helmets
  • Children’s helmets
  • Motorcycle helmets
  • Construction helmets
  • Military helmets
  • Ski helmets

Continue reading Helmet Safety Standards in the European Union: An Overview

Amazon Lithium Batteries Requirements For Sellers: An Overview

Posted on by Chuiyan Mo — 15 Comments

Lithium Batteries Requirements

Planning to sell lithium batteries or electronic products containing lithium batteries on Amazon? In this guide, we will cover what all Amazon sellers must know about safety standards and regulations, lab testing, certification, and other requirements.

Note: This guide only covers product regulations, standards and other requirements for selling on Amazon in the United States. However, the same principles apply when selling products on Amazon in the European Union, Australia, Japan, and elsewhere. Further, Amazon can change their own terms and requirements at will. This article serves as an introduction, but not a replacement for the up to date seller requirements on the Amazon Seller Central. Continue reading Amazon Lithium Batteries Requirements For Sellers: An Overview

List of Products Covered by the Radio Equipment Directive (RED)

Posted on by Vincent Cheng — 1 Comment

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)

List of Products Covered by US FDA Regulations

Posted on by Chuiyan Mo — Leave a comment

FDA products

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