Regulatory Compliance Services
Specialized product certifications to your product
Our Regulatory Compliance Services support organizations in meeting international regulatory requirements, including CE marking for access to the European market and FDA registration for entry into the United States. Through our expert guidance and collaboration with trusted partners, we ensure a smooth and straightforward process from application to documentation and final registration. Our approach is focused on accuracy, efficiency, and full compliance, giving clients the confidence to expand into global markets with ease.
Products and Services offered
CE Marking
CE Marking is a regulatory compliance mark that indicates a product meets the European Union (EU) safety, health, and environmental protection requirements. It is mandatory for certain products to be sold within the European Economic Area (EEA). Key Points: Not a certification: CE marking is a declaration by the manufacturer that the product complies with relevant EU directives. Applies to multiple product categories: Including electronics, machinery, medical devices, toys, construction products, and more. Manufacturer responsibility: The manufacturer must ensure the product meets the essential requirements, perform conformity assessment, maintain technical documentation, and affix the CE mark. Market Access: Products without CE marking cannot be legally sold in the EU/EEA.
FDA Registration
Knowledge Mag Certifications (KMC), in collaboration with UQSR Global, makes FDA registration straightforward and hassle-free. The process is simplified into three key steps: A-Application – Submit your request for FDA registration through KMC. We guide you in identifying the correct registration type for your product. B-Submission of Required Documents – KMC assists in preparing and compiling all necessary documentation, ensuring compliance with FDA requirements. C-Registration Confirmation – Once the FDA reviews and approves the submission, your product is officially registered and ready for the U.S. market. Our team ensures the process is smooth, fast, and fully compliant, allowing you to focus on your business while we handle the regulatory requirements.
Contact Us
Sri Lanka
Knowledge Mag Certifications Pvt Ltd
No 95, Muruthana Road, Kochchikade.
Australia
Knowledge Mag Certifications Australia Pty Ltd
907/710,
Station Street,
Box Hill
VIC 3128
