Medical Devices Cosmetics Training

Understanding Medical Devices vs. Cosmetics: Join Our MedTech Regulatory Training Series

In today’s global market, the line between medical devices, cosmetics, and borderline products is increasingly blurred. From skincare serums with high-tech claims to wearable health gadgets, understanding the regulatory classification of your product is essential to avoid non-compliance, product recalls, or delays in market entry.

That’s why AF Pharma is launching a MedTech Regulatory Training Series—a 3-part program designed for manufacturers, brand owners, startups, and consultants seeking clarity on how to classify and regulate their products internationally.

🎯 What Will You Learn?

Session 1: Definitions, Mechanisms of Action & Regulatory Frameworks

• What is a medical device vs. a cosmetic in the EU, UK, US, and China?

• Understand mechanisms of action and their role in product classification

• Get to know the key legal frameworks!

Session 2: Borderline Product Case Studies (Coming Soon)

• Explore examples such as:

  • LED masks

  • Eye patches

  • Creams with active claims

  • Serums with functional ingredients

• How to apply the right framework using real-world cases

Session 3: Practical Guidance for Compliance (Coming Soon)

• Labeling, claims, and dossier tips for each jurisdiction

• How to prepare Technical Documentation, PIFs, and 510(k) submissions

• Choosing the right regulatory path for your product

  
  

🌍 Why Is This Training Essential?

Misclassifying your product as a cosmetic when it functions like a medical device—or vice versa—can result in:

• Enforcement actions and fines

• Product bans or recalls

• Lost investor or consumer trust

• Delays in international expansion

Our training is designed to empower your team with clarity and confidence to choose the right regulatory strategy and avoid costly mistakes.

👩‍💼 About the Trainer

Regulatory Affairs Specialist at AF Pharma, brings over a decade of global expertise in medical devices, cosmetics, dietary supplements, and borderline product classification. She has helped over 300 brands navigate complex markets in the EU, UK, US, and Australia.

📝 Who Should Attend?

• Regulatory Affairs Professionals

• Quality & Compliance Managers

• Brand Owners & Product Developers

• MedTech Startups

• Cosmetic Innovators exploring borderline products

💡 Why Train with AF Pharma?

AF Pharma is a global regulatory consulting firm specializing in:

✅ Medical Device CE/UKCA/FDA approvals

✅ Cosmetics PIFs & MOCRA compliance

✅ UKRP, EU Rep & US RP services

✅ Personalized support for startups & SMEs

When you train with us, you learn from professionals who do this every day.

Don’t Miss Out – Reserve Your training session!

Gain a competitive edge in product development and global compliance. Join us for this essential training series and turn regulatory complexity into strategic advantage.

📧 Questions? Contact us at info@afpharmaservice.com

🌐 Learn more: www.afpharmaservice.com