Our Regulatory Affairs department manages registrations and listings with the FDA and licenses with Health Canada. We oversee compliance with all applicable federal and state regulations as well as regulations applicable to federal programs and contracts. This includes Health Insurance Portability and Accountability Act (HIPAA), export control, and Occupational Safety and Health Administration (OSHA), including issuance of Material Safety Data Sheets (MSDS).
Sysmex America’s Quality Management System policies define our arrangements for managing operations and activities across all disciplines and at all levels within the company in accordance with the framework established by FDA Quality System Regulation (21 CFR Part 820); Canadian Medical Device Regulation (CMDR); and ISO 13485:2003, ISO 9001:2008, and ISO 14971:2009. Our Quality Manual defines our plans and protocols for achieving quality assurance and customer satisfaction.
At Sysmex America, Inc., we believe that quality in healthcare is everyone’s responsibility. To learn more about our regulatory and compliance approach, refer to the information and links below.
Quality Policy: Our policy is to provide products and services with unmatched quality, reliability, and advanced technology to achieve total customer satisfaction and confidence. We meet or exceed customer requirements and comply with regulatory requirements. Every associate’s conduct reflects our duty and commitment to quality in all aspects of our business. This policy is supported through management review, customer feedback, and maintenance of an effective Quality Management System.
ISO Certifications: Sysmex America, Inc. has been certified to ISO 9001 since 2003 and ISO 13485 since 2010. Copies of our ISO certificates appear below.
ISO 9001-2008 exp Feb 2013.pdf
ISO 13485-2003 exp Feb 2013.pdf
HIPAA and Privacy: Sysmex America, Inc. (SAI) has adopted a Confidentiality & Non-Disclosure Agreement Policy to comply with the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and HITECH Act . This policy is also designed to ensure we fulfill our responsibilities for securing the confidentiality and integrity of confidential medical information (defined in HIPAA as protected health information (PHI), stored or transmitted electronic protected health information (ePHI) and other sensitive information) as required by law and will be supported via a formal associate training program.
Trade Security, US Export Control: Some Sysmex products are classified as “Dual Use” commodities as defined by US Export Administration Regulations (EAR), 15 CFR Part 730. These are products that could potentially be used either commercially or militarily and, as such, are regulated by the US Department of Commerce. Consequently, we are obligated to demonstrate proper due diligence and aim to achieve the following Global Sysmex Security Trade Control objectives:
Comply with all US domestic and international import/export laws and regulations in support of international peace and safety.
Export all Sysmex finished products, items or commodities regulated by these regulations based upon administrative permission; and restrict export to countries or end-users who intend to use these commodities for either the development or production of weapons of mass destruction (WMD).
Prevention of illegal exports either directly or indirectly to a party that is listed on one of the various Restricted (Black) Lists.
Access to SAI's site is restricted to persons who are not "Denied Persons" or "Designated Foreign Nationals" as such phrases are defined under US export laws and regulations. The "List of Denied Persons" is currently available at www.bis.doc.gov (The Bureau of Industry and Security) and the "List of Designated Foreign Nationals" is currently available at www.ustreas.gov/ofac. SAI Contracted Partners access information and materials on the Sysmex site at their own risk.
Specifically, you warrant to Sysmex that:
1. You do not appear on the List of Denied Persons or the List of Designated Foreign Nationals and in the event that you subsequently appear on either list, you will immediately cease to use the site.
2. You are not located in, under the control of, or a national or resident of any country to which the US has embargoed goods.
3. You will not access, download, use or export information, software, products or services contained on this site in violation of the US export laws or regulations, or in violation of any applicable local laws or regulations.
4. You will comply at all times with any export laws and regulations applicable to you.
Sysmex America, Inc. (SAI) Corporate Operating Procedure (COP) establishes the standard methodologies used by Sysmex America, Inc., Sysmex Reagents America, Inc. (SRA) and Sysmex Canada, Inc. (SCI) for complying with US Export Administration Regulations (EAR), 15 CFR Part 730.
FDA Establishment Registrations: Manufacturers of all medical devices are required to register their establishments and list their devices with the FDA. To view registrations and listings on the FDA data base, click here.
Health Canada Establishment License: Health Canada requires entities who import or sell medical devices in Canada to obtain medical device establishment licenses. In addition, manufacturers are required to hold product licenses. To view our Medical Devices Active License Listing (MDALL), click here.