Certified, Validated, and Trusted Worldwide
Every Veltek product is manufactured, tested, and documented in accordance with applicable GMP, ISO, FDA, EPA, and global regulatory requirements — giving you reliable, audit-ready performance.
Compliance Is Built Into Everything We Do
… and everything we teach.
For more than 40 years, Veltek has built compliance into every product, process, and cleanroom innovation we create. Our approach comes from listening to customers, solving real GMP challenges, and designing systems that hold up under regulatory scrutiny. It’s the same practical experience our specialists now share with teams looking to strengthen their own contamination control strategy.
Our Certifications
Certification
Description
Ministry of Environment (MoE), National Institute of Chemical Safety (NICS), K-BPR
South Korean regulatory framework for consumer chemicals and biocides.
EU REACH (EC 1907/2006)
Registration and control of chemical substances in the European Union.
NSF Certification (In Progress)
Public health and safety certification for select products.
ISO 9001:2015 (Pending)
Corporate quality management system standard.
IEC 62366-1
Usability engineering standards for medical devices.
ISO 14971
Risk management requirements for medical devices.
ISO 11737
Microbiological methods for evaluating sterilization processes.
ISO 11607
Packaging requirements for terminally sterilized medical devices.
ANSI/AAMI/ISO 11137
Radiation sterilization standards for healthcare products.
ISO 13485
Quality management system requirements for medical devices.
Ministry of Economy, Trade and Industry (METI)
Japanese authority overseeing industrial and chemical regulations.
Ministry of Health, Labour and Welfare (MHLW)
Japanese authority governing medical and health-related products.
National Health Commission (NHC)
National authority overseeing chemical and health regulations in China.
Therapeutic Goods Administration (TGA)
Regulatory authority for therapeutic goods in Australia.
Ministerio de Salud (Panama)
National health authority responsible for product and facility registration.
Health and Safety Executive (HSE)
Workplace health and safety regulation in the United Kingdom.
EU Medical Device Regulation (EU 2017/745)
Regulatory requirements for medical devices marketed in the EU.
European Commission (EC)
Governing body overseeing EU regulatory frameworks and directives.
EU Biocidal Products Regulation (EU 528/2012)
Regulatory framework for biocidal products in the European Union.
European Chemicals Agency (ECHA)
Oversight authority for chemical regulation within the European Union.
Health Canada – NNHPD (Part 3 GMP)
Good Manufacturing Practice requirements for regulated health products in Canada.
Natural Health Products Regulations (SOR/2003-196)
Canadian regulatory framework for natural and non-prescription health products, including GMP requirements.
Hazardous Products Regulations (SOR/2015-17)
Canadian regulations governing classification, labeling, and safety of hazardous products.
WHMIS (Canada)
Hazard communication and chemical safety requirements for workplace materials.
Health Canada – Biocides Regulations (SOR/2024-110)
Canadian regulatory framework for biocidal products.
Health Canada – NNHPD
Oversight of natural and non-prescription health products in Canada.
DOT / PHMSA (U.S.)
Regulations governing the transportation and handling of hazardous materials.
OSHA (U.S.)
Workplace health and safety regulations for employee protection and hazard control.
EPA – FIFRA (40 CFR Parts 150–189)
U.S. regulatory requirements for the registration and use of disinfectants, sanitizers, and sporicides.
FDA – Section 505G (FD&C Act)
Regulatory framework governing OTC drug products in the United States.
FDA - 21 CFR Part 210 & 211
Current Good Manufacturing Practice (cGMP) requirements for finished pharmaceutical products in the United States.
Our facility, product, and brand registrations include, but are not limited to, the listings above. Registration status varies by product and region. Please contact Veltek for specific registration details.
Compliance Proven, Not Just Promised
Your teams need clear, complete documentation they can rely on — whether preparing for an audit, qualifying a new process, or managing daily compliance tasks. That’s why every product comes with records for QA, QC, and validation that depend on certificates, testing data, change control history, and traceability from batch to batch.
With everything in one place, your teams spend less time chasing documents and more time focusing on what matters: running a compliant, confident operation.