In-Country Representative & Listing Services
EC REP / EUDAMED listing
CH REP / SWISSDAMED listing
UKRP / MHRA PARD listing
US Agent / FDA listing
Egyptian registration holder
SFDA registration
Free Sales Certificates
EU FSC from Netherlands
CH FSC from Switzerland
UK FSC from United Kingdom
e-CFG from USA
In-Country Representative
QS Experts offers you all relevant representation mandates in Europe, the United States, Africa and the Middle East from a single source. As an experienced partner, we take on the role of your Representative in accordance with MDR/IVDR, FDA and SFDA requirements. This avoids unnecessary duplication and noticeably reduces your administrative and regulatory costs.
At the same time, you increase your compliance security, as all mandates are centrally coordinated and documented.
Trust in our in-depth experience in the regulatory environment and benefit from a holistic solution that is oriented towards the requirements of your products and markets:
- Swiss Authorized Representative (CH-REP)
- European Authorized Representative (EC REP)
- UK Responsible Person (UKRP)
- US Agent
- Egyptian registration holder
- Saudi FDA Registion
Why choose QS Experts as your Representative?
At QS Experts, we specialize in providing top-tier In-Country Representative services to ensure your business meets regulatory requirements worldwide.
Enhanced Compliance Security:
By centrally coordinating and documenting all mandates, QS Experts helps increase your compliance security.
Avoid Duplication:
This approach avoids unnecessary duplication and significantly reduces your administrative and regulatory costs.
Streamlined Compliance:
With a single point of contact for the America, Europe, Africa and the Middle East, you streamline compliance and reduce administrative burdens.
Regulatory Cooperation:
QS Experts cooperates with competent authorities to report serious incidents, adverse events, and CAPA processes.
Holistic Solution:
Benefit from a holistic solution tailored to the requirements of your products and markets.
Regulatory Importer Representation
USA, UK, EU & Switzerland
Why Designate a Regulatory Importer?
In each target market, the Regulatory Importer plays a crucial role in ensuring compliance with local medical device regulations. The Importer is a legally recognised economic operator with specific obligations, ranging from verification of compliance documentation to post-market surveillance.
Your Independent Regulatory Importer for Global Markets
By appointing us as your independent Regulatory Importer, you avoid relying on distributors to fulfil this role, which allows you to maintain commercial independence while ensuring full regulatory compliance. We provide harmonised processes across all jurisdictions, tailored to the specific legal framework in each market.
Our Core Regulatory Importer Services
Across all markets, our importer role includes:
Your Benefit
With a single point of contact for the USA, UK, EU, and Switzerland, you streamline compliance, reduce administrative burden, and ensure that your products meet all importer-related legal obligations in each market.
Free Sales Certificates
Experience seamless certification with our expert services designed to support manufacturers in obtaining essential certifications quickly and efficiently. We specialize in guiding you through the process to achieve the EU FSC certification. In Switzerland, we facilitate the CH FSC certification, while in the United Kingdom, we help you secure the UK FSC certification. Additionally, our expertise extends to the e-CFG certification from the USA, ensuring your products are ready for both domestic and international markets. Trust us to streamline your certification journey and help you meet the requirements of competent authorities with ease.
- CH FSC: This is the FSC certification specific to Switzerland.
- UK FSC: This refers to the FSC certification in the United Kingdom.
- e-CFG: This might be the electronic Certificate of Free Sale from the USA, which is often used to certify that products sold in the USA are also eligible for export.
If you are interested to get more information about our Free Sales Certificate services, please contact us to get more information about requirements and conditions of this service.
Warehousing Service
In today’s evolving global landscape, stringent regulatory requirements and frequent changes in medical device legislation pose significant challenges for manufacturers seeking to enter multiple markets. Our team of seasoned professionals possesses in-depth knowledge and practical experience navigating these complexities in numerous jurisdictions, including North America, Europe, Asia-Pacific, and other emerging markets. This enables us to ensure that your devices are consistently aligned with the diverse and often intricate regulatory frameworks relevant to each target country.
Expand your reach with our strategically located warehouses, designed to ensure fast delivery and leverage local market expertise! Our EU Warehouse guarantees swift distribution across the European Union, while our Warehouse in Switzerland offers efficient logistics in the heart of Europe. Additionally, our Warehouse in Egypt provides a gateway to the Middle East and North Africa, ensuring your products reach their destinations quickly and reliably. Trust us to deliver your products with unmatched speed and local market knowledge, no matter where your market is.
our exclusive and meticulously designed integrated service offering that we are confident will greatly enhance the international distribution capabilities and regulatory compliance of your medical device products across various global markets.
Our proposal involves bundling our internationally recognized authorized representative services with our extensive expertise in providing legal and regulatory support specifically focused on compliance with medical device requirements worldwide. This combination creates a robust and comprehensive solution that is tailored to facilitate the unrestricted and seamless movement of your medical devices across international borders, thereby expanding your global reach and operational footprint.
By partnering with us, you gain access to a dedicated team committed to managing all facets of regulatory adherence from initial documentation preparation and submissions through to post-market surveillance and ongoing compliance monitoring. We focus on minimizing regulatory risks, accelerating approval timelines, and reducing administrative burdens, which in turn allows your company to focus on its core competencies such as research, product development, and innovation.
Moreover, our services extend beyond compliance to include strategic advisory on evolving regulatory landscapes, guidance on changes in international standards, and assistance with certification renewals and audits. This holistic approach ensures that your medical devices not only meet but exceed global quality and safety standards, fostering greater confidence among stakeholders, healthcare professionals, and end-users.
We understand that each medical device product has unique features and market requirements. Therefore, our bundled service can be customized to your specific business needs, product types, and targeted regions. We pride ourselves on establishing long-term partnerships characterized by transparency, responsiveness, and mutual success.
Get Started with us today
QS Experts offer a wide range of services Whether you’re launching a new product or expanding internationally