Registration certificate update
Dear colleagues,
please be informed, that that changes in the data in the registration certificate and/or technical, operational documents for medical device, as well as other official documents related to the medical device being registered in official bodies of Ministry of Health of Russian Federation (Roszdravnadzor), entails a renewal of the registration certificate (in certain cases equate to obtaining a new registration certificate), based on Rules of state registration of medical devices (approved by the Decree of the Government of the Russian Federation of December 27, 2012 №1416)
On the basis of the Rules of the state registration of medical devices (hereinafter - the "Regulations") as n. 37 changes in the registration certificate should be done in the following cases:
a) changes in the information about the applicant, including information:
- on the reorganization of the legal entity;
- change of company name (full company name or reduced), including brand name, address (location);
- a change of surname, name and (if available) middle name, residential address of the individual entrepreneur, details of the document proving his identity;
b) change of address (place of production) of the medical device;
c) change of the name of the medical device (if not changed the properties and characteristics that affect the quality, efficacy and safety of a medical device);
d) a change of the legal entity in whose name may be issued a registration certificate, including information:
- on the reorganization of the legal entity;
- change of its name (full company name or reduced), including brand name, address (location);
e) indication of the type of medical product according to the nomenclature Classification of medical devices (in his absence).
Thus on the basis of article 55 of the Regulations, if necessary to make changes to the documents referred to in subparagraphs "c" and "d" of paragraph 10 of the Regulations, meaning the technical documentation of the manufacturer for medical product and maintenance documentation for medical device, including instructions for use or operating instructions for the medical device. In these cases, changes to registration certificate should be based on the results of expertise carried out in a manner similar to the procedure of examination of quality, efficacy and safety of a medical device for its state registration in accordance with claim 21 of the Regulations.
At the same time claim 21 of the Regulations, the examination of the quality, effectiveness and safety of medical devices is carried out in stages expert institution in accordance with the procedure approved by the Ministry of Health of the Russian Federation:
a) at stage 1 carried out examination of the Application for registration and the documents referred to in paragraph 10 of the Regulations, to determine the possibility (or impossibility) of conducting clinical trials of a medical device;
b) at the II stage, the examination of the completeness and the results of technical tests, toxicology studies, clinical trials and tests for the approval of the type of measurement (for medical devices related to measuring instruments).
Application to update or change existing Registration certificate should be submitted to the registration authority (Roszdravnadzor) not later than 30 working days from the date of changes done to the information in the technical, operational documents for medical device.
Failure to comply with these requirements of the Regulations, the territorial authority of Roszdravnadzor suspends the medical device on the market.
For failure or misrepresenting the person to whom this information have become known for their professional activities, are subject to disciplinary, administrative or criminal responsibility in accordance with the legislation of the Russian Federation.
According to Russian law, there are three specific offenses:
- Illicit manufacturing of medical devices without special permission (license) if such permission (license) is required (mandatory) (Art. 235.1 of the Criminal Code);
- The production, sale or import into Russia of counterfeit medical products, or sale or importation into the territory of the Russian Federation substandard medical products, or illegal manufacture, sale, or importation into the territory of the Russian Federation for the purpose of sale of unregistered medical products ( Art. 238.1 of the Criminal Code );
- Production for use or sale, or use of fake documents on medical devices (registration certificate, a certificate or declaration of compliance, regulatory, technical and operational documentation of the manufacturer (manufacturer) Medical Products) (parts 1 and 3 of Art. 327.2 of the Criminal Code).
Prosecution under these articles can be for acts committed in relation to medical devices with a value of more than 100,000 rubles.
CEO or other officer of the company, performing management functions, may hold criminal proceedings / responsible for the final decisions on the activities of the company, which has made the above steps:
- The manufacturer (Art. 235.1 of the Criminal Code);
- The manufacturer, the authorized person of the foreign manufacturer, distributor (Art. 238.1 of the Criminal Code);
- Manufacturer of fake documents for medical products or the company using such documents (parts 1 and 3 of Art . 327.2 of the Criminal Code) - in other words , here you can include both the manufacturer and it’s representative acting under the POA provided by the manufacturer in the registration process as well as distributor.
In view of the above, please pay attention to these regulations when making any changes in the registration certificate and/or technical, operational documents, medical device and immediately notify the public authorities in the prescribed form of any updates!
Please contact us for a free proposal or more information on medical device registration in Russia: Tel: +7 (495) 7760939, info@med-ser.com
Информация на сайте не является публичной офертой.