Registration certificate of Roszdravnadzor is issued on a form of the established layout. Each medical device registration certificate has a unique number assignment for accounting and protection against forgery.
Sample of the registration certificate for a medical device
The RC contains the following information (see the sample RС):
1 – date of the medical device state registration and the registration number of the certificate;
2 – name of the medical device. Please, note that information about the accessories necessary for the intended use of the medical device is also indicated. Detailed information about accessories is provided In the Appendix to the RC (see the drawing);
3 – full and (if available) abbreviated name of the legal entity in whose name the registration certificate was issued, including name, legal form and address (location) of the company;
4 – manufacturer (producer) of the medical device: full and (if available) abbreviated name, including the name, legal form and location address of the company, or last name, first name and (if available) patronymic name, details of the identity document, place of residence of the individual entrepreneur;
5 – place of manufacture of the medical device;
6 – the number of the registration dossier. It allows you to identify the set of registration documents which is stored in Roszdravnadzor;
7 – class of potential risk of the medical device application determined by the nomenclature classification of medical devices;
8 – code in accordance with the All-Russian classifier of products by type of economic activity (OKPD 2 code);
9 – number of sheets in the Appendix to the RC;
10 – number and date of the order of Roszdravnadzor, on the basis of which the medical device is approved for application in the territory of the Russian Federation;
11 – position and full name of the authorized person who approved the RC;
12 – number of the RC form.
Sample of the appendix to the registration certificate for a medical device
The registration certificate is often accompanied by an appendix. It contains the following information (see the sample appendix):
1 – design variants;
2 – composition of the medical device;
3 – accessories to this medical device;
4 – position and full name of the authorized person who approved the appendix to the RC;
5 – number of the appendix form (for accounting and protection against forgery).