What is the difference between a registration certificate and a certificate of conformity for a medical device?

When launching a medical device on the market in Russia, the key legal document is the registration certificate. It confirms that the product is indeed recognized as medical, has passed the state assessment of safety, quality, effectiveness and is approved for use on the territory of the Russian Federation. Without a registration certificate, an MI is considered not allowed to the market, regardless of the availability of other documents.
The certificate of conformity has a different legal nature and is not related to the approval of the product for medical use. It confirms the conformity of products with established technical requirements, standards or technical regulations, but does not determine the legal status of the product as a medical device. Therefore, the certificate does not give the right to use a medical device and does not replace state registration.
The difference between these documents is the level of regulation. The registration certificate relates to the scope of the product's admission to medical treatment and is aimed at assessing its safety and effectiveness. The certificate of conformity refers to the system of technical regulation and confirms the individual characteristics of the product without evaluating its medical purpose.
At the same time, in practice, the certificate of conformity can be used as an auxiliary document. It may be required to fulfill certain technical requirements, customs procedures, or contract terms.
In some cases, such documents are included in the registration dossier, but they always remain secondary to the registration certificate. A set of documents for a medical device is formed primarily around the registration certificate. All other documents are important only in conjunction with the current registration and cannot independently legalize the circulation of the product.