What is a Medical Importer of Record (IOR)?
A medical IOR is a company or individual that is responsible for ensuring that imported goods comply with all relevant laws and regulations in the country where they are being shipped. This includes ensuring that the products meet safety, health, and environmental standards, as well as obtaining any necessary permits or licenses. In the case of ancillary products used in clinical trials, the IOR is responsible for ensuring that the products meet the regulatory requirements of the country where the trials are taking place. This can include obtaining approval from the local regulatory body and ensuring that the products are labeled and packaged correctly.
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Our Services
Our experienced team understands the complex and ever-changing regulations governing the import of medical products for clinical trials. We work closely with our clients to ensure that their products meet all relevant laws and regulations while minimizing supply chain risks and maintaining high–quality standards.
Regulatory Compliance
We provide guidance on the local regulatory requirements and aid in complying with all relevant trade regulations.
Customs Clearance
We aid in complying with all relevant trade regulations.
Supply Chain Risks
We help identify and mitigate potential risks associated with the supply chain, such as fraud or intellectual property infringement.
Quality Control
We assist in implementing strict quality control procedures and conduct regular audits.
Logistics and Transportation
We provide logistics and transportation services to ensure that the products are delivered to the trial site on time and in good condition.
Custom Compliance Consulting
We provide custom compliance consulting services to help clients navigate the ever-changing regulatory landscape and ensure they are compliant.
Global Importers
One of the key advantages of TecEx Medical is our global reach. We have a network of offices and partners in key global markets, enabling us to provide local support and expertise when navigating different countries’ regulatory and compliance requirements. This is particularly important for clinical trials, which often take place in multiple countries, each with its regulations and compliance requirements.
Another advantage of TecEx Medical is our deep knowledge and expertise in compliance. Our team of experts thoroughly understands the complex and ever-changing regulations that govern the import of medical products for clinical trials. This includes knowledge of the regulations in countries with strict requirements, such as Brazil, and within the European Free Trade Association (EFTA) and the European Union (EU).