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Registration Certificate |
Registration Certificate of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation (previously issued by the Ministry of Health of the Russian Federation) is a document confirming the registration fact of medical products in the territory of the Russian Federation and addition them into the database for the medical products. According to the Administrative Regulations of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation, the registration of medical products approved by the Resolution №735 of the Ministry of Healthcare Service and Social Development of the Russian Federation dated on October 30, 2006. All medical products, including devices, tools, and so on for the medical use are subject to mandatory registration in the Russian Federation. Registration Certificate of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation indicates that the products allowed for import (or production), sale and use in the territory of the Russian Federation. In other words, an alcohol tester or breathalyzer may not be used for medical purposes, if they do not have the registration certificate. Therefore, a dealer must give a certified copy of the registration certificate to a buyer when selling such a device.
Each registration certificate has a number. When you determine the validity period of the registration certificate you must consider a date when it issued.
Currently, you may meet three types of registration certificates:
• Registration certificate of the Ministry of Health of the Russian Federation, this type of certificate issued before 2004 and are valid for 10 years from the date indicated on the form of certificates.
• Registration certificate of the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation, this type of certificate issued after the reorganization of the Ministry of Health during 2004 up to the date of entry into force of the Administrative Regulations that covered the registration of medical products. They valid for 10 years from the date indicated on the form of certificates.
• Registration certificate of the Federal Service on Surveillance in Healthcare and Social Development of Russian Federation issued according to the Administrative Regulations that covered the registration of medical products. They do not expire and are valid under condition to keep the originally listed information about medical products and the person in whose name the medical product registered. The validity period of such registration certificate is not limited.
http://www.roszdravnadzor.ru/national_foreign_medprod/Reg_med_products/normativacts
Here is a link to renewal in RU: https://www.rosminzdrav.ru/docs/mzsr/35/1
Terms for the certification and registration of other permitting documentation depend on the product specifications, the nature of the examination and laboratory tests.
Strateg Overseas interacts with the customers using a specially developed method, which includes the individual system of discounts, extra services and consideration for professional interests.