Regulatory Compliance and Safety Standards for Aesthetic Devices Training Course

Course overview

Medical devices with no medical purpose, commonly referred to as aesthetic devices, present unique regulatory challenges for the cosmetic industry. While these devices do not treat or diagnose medical conditions, they must meet rigorous safety and efficacy standards, often comparable to those for medical devices (e.g., liposuction devices, dermal fillers). As such, aesthetic devices often exist in a regulatory grey area, as they serve non-therapeutic purposes. This ambiguity makes determining their classification - whether as medical devices or consumer products - complex.

The field of aesthetic devices is governed by stringent regulatory compliance and safety standards to ensure consumer safety and product efficacy. This involves adherence to global and regional regulations, such as FDA guidelines in the United States or CE marking requirements in Europe. Manufacturers must follow rigorous processes, including risk assessment, clinical evaluation, and quality management system (e.g., ISO 13485). Regulatory compliance not only mitigates risks but also fosters trust and credibility in the marketplace. Therefore, staying updated on regulations and safety standards is essential for professionals developing and working with aesthetic devices. 

Unlock the knowledge and skills to navigate the complex regulatory landscape of aesthetic devices with confidence. This course is designed to empower professionals in the cosmetic industry to excel in global markets by understanding and addressing compliance challenges.

This comprehensive course explores the unique regulatory landscape for medical devices with no medical purpose, commonly known as aesthetic devices. Designed for cosmetic industry professionals, it provides an in-depth understanding of compliance challenges, safety standards, borderline definitions in aesthetics devices, and marketing strategies to ensure successful product development and market entry.

Dive into the intricacies of device classification under frameworks like the EU Medical Device Regulation (MDR 2017/745), ensuring you’re equipped to meet regulatory requirements with ease. Learn how to demonstrate safety and efficacy for devices with subjective benefits using robust scientific evidence and gain the tools to craft marketing strategies that align with global standards while avoiding misleading claims.

Enhance your expertise in maintaining product safety through advanced post-market surveillance systems and effective adverse event monitoring. Explore how to navigate diverse international regulations, with insights into key regional differences, including the EU and U.S.A., to ensure seamless global compliance. Finally, discover best practices for fostering consumer trust through clear communication, and ethical transparency. 

By the end of this course, you’ll have the confidence to bring innovative aesthetic devices to market while maintaining the highest standards of safety, compliance, and credibility. 

Participants will be equipped with the knowledge and tools to effectively manage the regulatory, safety, and ethical complexities of aesthetic devices, ensuring compliance and success in the global cosmetic industry.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Benefits of attending

• Gain in-depth knowledge to navigate borderline definitions in aesthetics devices
• Ensure successful regulatory submissions in different global jurisdictions
• Maintain consumer trust and minimise legal risks by understanding marketing and claims

Who should attend?

This training is suitable for any professionals involved with aesthetic devices, including:

• Regulatory Affairs Professionals
• Product Development Teams
• Clinical Affairs Specialists
• Quality Assurance Managers
• Cosmetic Industry Professionals
• Healthcare and Aesthetic Practitioners
• Academic and Research Professionals
• Entrepreneurs and Startups

Enrol/reserve