Registration Certificate (for medical devices)

The registration certificate of Roszdravnadzor is a document issued for medical equipment and medical products, confirming the fact of their registration.

      Obtaining a Registration Certificate is necessary for all medical devices intended for circulation in the Russian Federation. Since January 1, 2013, the registration of medical devices is carried out in accordance with the Rules of State Registration, approved by the Decree of the Government of the Russian Federation of December 27, 2012 No. 1416.

ICCENTR offers consulting support for the registration process of medical devices, as well as preparing and adjusting the documents required for registration, organizing and conducting technical, toxicological, and clinical trials and submitting the completed registration dossier to the Federal Service for Supervision of Health.

     Registration of a medical product is made in the name of the legal entity or entrepreneur indicated in the registration application. Registration is carried out by the Federal Service for Supervision in the Sphere of Health and Social Development on the basis of the results of relevant tests and assessments confirming their quality, effectiveness and safety of medical products. The validity of the registration certificate time is not limited.

      Consideration of documents in Roszdravnadzor and making a decision on registration of a medical product is carried out within 4 months from the date of submission of the set of documents. The period for consideration of documents and the decision on registration may be extended for a period not exceeding 3 months in order to enable the applicant to conduct additional tests.

In order to issue a registration certificate for a medical product, the applicant submits the following documents to the Federal Service for Supervision of Health and Social Development:

• application for registration of a medical device;
• a document certifying the payment of state duty;
• certificate of medical devices;
• documents confirming the registration of the manufacturer as a legal entity;
• a power of attorney or a certified copy of the contract in the event that the applicant is not the manufacturer of the medical product;
• documents confirming compliance of the conditions of production of a medical product with the requirements of the legislation of the Russian Federation;
• a draft regulatory document together with documents confirming the compliance of a medical product with its requirements, or with the requirements of technical conditions or standards;
• a medical device instruction manual;
• draft instructions for medical use in the registration of physiotherapeutic devices and reagents (kits) for diagnosis (in vitro), independently used by the end user;
• documents confirming the equivalence or identity of a medical product to its counterpart;
• results of technical tests, safety assessments and medical tests of the efficacy and safety of a medical product.

All documents for registration of the Roszdravnadzor registration certificate for a medical product must be submitted in Russian or have a certified translation into Russian.

We are engaged in professional registration of registration certificates and certificates in Roszdravnadzor
We carry out urgent registration of veterinary registration certificate.
We carry out registration of the certificate of conformity and registration certificate.
We will help to issue registration certificates for medicines.

If you have additional questions on obtaining a registration certificate, you can ask our experts by phone:

+ 7 495 651 99 05