Global Regulatory Compliance

Your Authorized Representative & Responsible Person

At Obelis, we specialize in ensuring regulatory compliance for Medical Devices, Cosmetics, and other industries. Our Authorized Representative and Responsible Person services provide expert guidance for swift and safe market entry, tailored to meet the diverse needs of businesses. We span regulations in the EU, UK, US, Switzerland, Canada and beyond to support your compliance needs effectively.

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MOST REQUESTED SERVICES

Accelerate your market access with expert regulatory guidance

EU Authorised Representative US Agent & Official Correspondent Food Supplements EAR CE Marking Guidance Notified Body Application National Registration

Explore Our Global Services

Select your industry and your region to discover how we help your products enter and thrive in international markets.

Medical Devices & IVDs

Cosmetics

Other Industries

Medical Devices & IVDs

Cosmetics

Other Industries

European Union

United Kingdom

United States

Switzerland

Canada

European Union

United Kingdom

United States

Canada

Switzerland

Türkiye

General Products (GPSR)

Toys

Food Supplements

Specialised Equipment

Motor Vehicles

AVOID COSTLY MISTAKES

Failing to meet regulatory requirements can be expensive. We help you stay compliant.

Avoid costly mistakes and ensure legal market access across the globe with our representation services.

Product withdrawals and batch recalls

Prevent forced product removals and recalls that damage your brand.

Regulatory penalties and fines

Protect against heavy fines and sanctions for non-compliance.

Delayed market access

Accelerate approval times and access new markets faster.

Lacking regulatory representation

Secure a reliable Authorised Representative and/or Responsible Person to avoid market bans.

Explore how our global compliance services protect your business.

Cosmetics Medical devices

Why Obelis?

Since 1988, Obelis has been a trusted compliance partner for over 7,000 manufacturers worldwide. Our combination of regulatory expertise, dedicated support teams, multi-industry knowledge, and global compliance capabilities enables companies to navigate complex requirements with confidence and focus on growing their business.

About us

Trusted Since 1988

Founded in 1988, we have helped over 7,000 manufacturers from 90+ countries navigate regulatory requirements and access global markets. Having successfully guided clients through major regulatory changes, including MDR, IVDR, Brexit, and GPSR 2024, we bring over 37 years of trusted regulatory expertise.

Six Markets, One Trusted Relationship

Expand into the EU, UK, Switzerland, Canada, USA, and Türkiye with a single trusted partner. Our local entities and dedicated contracts ensure a seamless experience, allowing you to enter new markets without the need to onboard new providers or manage multiple relationships.

In-House Regulatory Affairs Team

We do more than act as your representative. Our dedicated Regulatory Affairs team provides hands-on support with MDR and IVDR compliance, EUDAMED management, regulatory guidance, and urgent compliance matters, helping you navigate complex requirements with confidence.

Multi-Industry Regulatory Expertise

From medical devices, cosmetics, and food supplements to consumer products, machinery, toys, and GPSR compliance, we provide regulatory support across multiple industries under one roof, helping companies manage diverse product portfolios through a single trusted partner.

Avoid Hidden Compliance Costs

Our support goes far beyond representation. From document reviews and regulatory correspondence to compliance guidance and ongoing assistance, we provide comprehensive support designed to reduce regulatory risks and help you avoid costly compliance issues.

Fast, Accessible Support

Our Sales and Customer Success teams work closely together to provide responsive, personalised support throughout your compliance journey. With dedicated points of contact, streamlined communication, and fast escalation paths, we ensure your questions are addressed promptly, typically within 24 hours.

years in business

products regulated

customer countries

Events, Webinars, and Deadlines

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Webinar – Global Cosmetic Safety: Mastering Multiterritory Assessment & Laboratory Testing

Jun 4

Webinar – Global Cosmetic Safety: Mastering Multiterritory Assessment & Laboratory Testing

3:00 pm – 4:00 pm
EU & UK Detergents Market Access: Regulations & Upcoming EU Changes

Jun 9

EU & UK Detergents Market Access: Regulations & Upcoming EU Changes

3:00 pm – 4:00 pm
Cosmoprof Las Vegas 2026

Jul 13

Cosmoprof Las Vegas 2026

July 13 – July 15

Why companies choose Obelis

We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.

Florian L. Gablenez Business Development Manager at Dirk Rossmann GmbH

I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain quick regulatory approval across several markets has had a profound impact on our company.

Ran Amos VP of Quality Assurance & Regulatory Affairs at Samsara Vision

Obelis helped us navigate complex regulatory landscapes, ensuring we met all legal and industry-specific obligations. Obelis deeply understands the cosmetic regulatory landscape and they have provided all the necessary support

Terry Luu Chemist at Home & Body Co.

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