A registration certificate issued by the Russian Ministry of Healthcare is an official document warranting that a product has been registered at the territory of the Russian Federation and is listed in the State register. It is obligatory to obtain this document before launching the sale of any medical products. Failure to procure the certificate can entail grave consequences, up to criminal liability.
The Russian Ministry of Healthcare issues the registration certificate for the following types of products:
- medical equipment;
- raw materials for pharmaceutical goods.
To get the certificate, the applicant has to submit a large number of documents: specification, technical and operation documents. The documents must be drawn with due attention, all necessary expert examinations must be carried out, as well as toxicity tests, compliance certificates must be acquired beforehand, etc. We offer our assistance in preparing all the documents required to apply for a registration certificate.
Besides the standard procedure of the registration certificate issue, you may be interested by the following documents and services:
- Licence for manufacturing and assuring maintenance of medical devices. This document contains all the requirements for the devices used in healthcare, for instance, diagnostics equipment, medical furniture, surgical appliances, entire treatment centres, etc. The licence is issued by Roszdravnadzor. Obtaining this licence is required to assure the patients’ safety during medical treatment. The licence is obligatory.
- Modifications to the registration certificate issued by the Ministry of Health. This step is required in the case of information on the medical product specified in its registration certificate has been changed. For example, this applies to the changes in the product appellation, manufacturer’s address or the bank details of the person responsible for the product sale.
- Issuing a duplicate/ reissuing the registration certificate. Required when the original copy of the document has been lost or stolen. The applicant has to submit documents confirming the issuing of the original registration certificate.
- Letter of exemption signed by the Russian Ministry of Health. The letter confirms the fact that the product is not subject to obligatory licencing and registration in the State register. The letter must contain a reference to the legislative act it is based upon. A letter of exemption may be required for importing and exporting products to or from Russia. It is considered a mandatory customs document and can be drawn for one specific product, as well as for a range of medical products.
Get a registration certificate and other documents in no time
We will assist you in performing the administrative procedures and preparing a package of documents required for any licence, duplicate or letter. The exact list of documents depends on the type of medical product. Our consultant will readily provide you precise and up-to-date information.
Visit our office at: 64 Zemlyanoy val, Bld. 2, Moscow,
+7 (495) 120-28-36,
+7 (800) 500-34-36 to ask your questions.