The completeness and accuracy of the documents of the output registration dossier are determined by multiple factors. The key ones we will discuss below. It is important to understand that the errors made at this stage can significantly increase the time and cost of registration and sometimes lead to a denial of registration.
In accordance with the Rules for the Classification of Medical Devices, all medical devices depending on their potential risk of application, are divided into 4 classes (the Rules are regulated by the Decision of the Eurasian Economic Commission No. 173 “On Approval of the Rules for the Classification of Medical Devices Depending on the Potential Risk of Application” dated December 22, 2015). The class of application risk to which a medical device belongs is one of the main criteria affecting the content of the registration dossier documents.
In addition to the class of potential risk of application, contents of the medical devices registration dossier are also determined by their type: the list of documents for products used for in vitro diagnostics has its own distinctive features.
Below we place a service which can help you receive an up-to-date list of registration dossier documents. In order to use it, select the risk class (1, 2a, 2b, 3) and type (in vitro, not in vitro) of your medical device in the drop-down list.