Marketing Submission
In the marketing submission phase of a diagnostic, comprehensive data are compiled to support FDA clearance or approval, or to ensure the test meets CLIA and/or state requirements for laboratory use and complexity classification.
US
Covita Health Partners provides comprehensive U.S. marketing submission support, including 510(k), De Novo, PMA, and HDE submissions. We also leverage our deep experience in FDA interactions to serve as a strategic liaison between your company and the agency, facilitating clear, effective communication throughout the process.
We also offer flexible and expert support for CLIA and state laboratory applications or accreditation processes, ranging from strategic guidance to hands-on preparation, tailored to your specific needs and level of readiness.
EU
Our team provides end-to-end support for EU marketing submissions, including the preparation of technical files or design dossiers required for CE marking under the In Vitro Diagnostic Regulation (IVDR). This includes the development of robust Clinical Evaluation Reports (CERs). With our deep understanding of EU regulatory frameworks, we help streamline the path to CE marking and maintain compliance throughout the product lifecycle.
Canada
We can support your product through the process of obtaining a Medical Device License (MDL) in Canada, across all classes of IVDs—from Class I to Class IV. We provide strategic guidance and hands-on support in preparing and submitting the required documentation in accordance with Health Canada’s regulatory requirements, helping you navigate the process efficiently and position your product for a successful product launch.
UK
If you are pursuing UKCA marking for your IVD, our team can support the preparation of a comprehensive technical file or design dossier in accordance with MHRA requirements, helping ensure a smooth and compliant path to market in the UK.
Rest of World (ROW)
A technical file or design dossier is required to obtain marketing authorization for entry into most global markets. In some regions, proof of regulatory approval in major markets, such as the U.S. or EU, may be leveraged to streamline approval in smaller or emerging markets. With deep international regulatory expertise, Covita Health Partners can help you navigate these varied requirements and determine the most efficient path to global market entry.