4 |Checking Local Legislation
We manufacture products for use in approximately110 countries and regions around the world.
Obviously, different laws and regulations apply, so we are always working to ensure our products conform to the laws and regulations of the individual locations.
Various pharmaceutical, safety, and environmental regulations around the world affect our product designs to ensure that we meet prevailing regulatory guidelines. At the same time, we also ensure that our manufacturing standards meet global initiatives for reduced carbon footprint.
- • Japan - Pharmaceutical Affairs Law regulating the manufacturing, importation, and sale of drugs and medical devices, Electrical Appliance and Material Safety Law.
- • USA - Federal Food, Drug, and Cosmetic Act (FDCA), recognition standards of the Nationally Recognized Testing Laboratories (NRTL). Significant New Alternatives Policy (SNAP),
- • Europe - Medical Device Directive (MDD), Restriction of Hazardous Substances (RoHS directive), Waste Electrical and Electronic Equipment (WEEE directive), F-Gas Regulations and other directives.
Laws and regulations are constantly changing and in order to stay up-to-speed with existing regulations worldwide, our Legislative Division is always monitoring changes. Although designing and manufacturing products for a global market means that we need to design for the most strict of those standards, the end result is that our customers receive the most robust and environmentally friendly products.