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The EU General Product Safety Regulation (GPSR), Regulation (EU) 2023/988, becomes applicable on 13 December 2024. With over 36 years of regulatory expertise, Obelis is your trusted partner for seamless compliance. As your Authorised Representative and Responsible Person, we ensure your products meet GPSR requirements. Contact us now!
Obelis goes to Arab Health 2025. Book a meeting.
The Cosmetic Regulations were amended in April 2024 to – among other things - expand the definition of "manufacturer" to mean: 💠A person in Canada who sells the cosmetic under their own name or a trademark, design, trade name, or other mark they own or control. 💠A person in Canada authorized to act on behalf…
Navigating the EU In Vitro Diagnostic Regulation (IVDR) and Health Canada requirements can be challenging. Understanding the role of Notified Bodies and regulatory expectations is crucial for compliance and market access. Our exclusive webinar will cover: ✅Strategies for efficient regulatory compliance in both regions ✅Key differences between EU IVDR and Health Canada requirements ✅The role of Notified Bodies and how they impact IVD approvals 🎯 When: March 18th | 16:00-17:00 CET…
Product launches and innovative solutions? Counting you in for Cosmoprof Bologna! Our goal is to assist your company in smoothly complying with global regulations and we will be there to support you. Why Meet Us at Cosmoprof Bologna? ✅ Expert insights on market access & compliance✅ Tailored strategies to accelerate approvals✅ Guidance on the latest…
Bringing Your Dental Devices to Market? Join us at IDS, the world’s leading trade show for dental innovation! We’re here to help dental and medical device manufacturers easily navigate global regulations. Why Meet Us at IDS? ✅ Expert insights on market access & compliance✅ Tailored strategies to accelerate approvals✅ Guidance on the latest regulatory updates…
Join our webinar to get the inside scoop on EUDAMED compliance and make the process easier for your company. We'll break down what data is public in EUDAMED and explain how it affects your business. You’ll learn how to correctly assign and use EMDN codes and stay on track with important EUDAMED deadlines to keep your operations running smoothly, and much…
On October 3, 2024, the United Kingdom took a significant step toward tightening cosmetic safety by notifying the World Trade Organization (WTO) of a draft amendment to its GB Cosmetics Regulation. This update introduces 13 more chemicals to the growing list of banned substances, all of which are classified as carcinogenic, mutagenic, or reprotoxic (CMR).…
Handling EU regulations can be challenging, but our expert-led webinar will give you the insights you need to stay compliant and efficient. Learn about VAT obligations, EPR rules across countries, customs clearance, post-Brexit shipping considerations, and GPSR product requirements. Don’t miss this opportunity to equip yourself with the knowledge to expand confidently! Here’s what you…