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 In the Russian Federation all medical devices for use diagnostic and therapeutic purposes must be registered in Moscow, at the central department of the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor), which at the end of a process issued a certificate of registration. The certificate shall indicate the name of the producer, the name of device, the intended use and the class of potential risk to the patient, information on any similar.
If the medical device is a unit complex, consisting of more components (modules), the certificate of registration shall be accompanied by a Annex, that shall identify all components that make up and any accessories with which it is provided.
If the components (modules) are produced by different manufacturers and marketed under their own brand, the certificate of registration used for each component. In this case, before proceeding with the registration is advisable to verify that the component in question has not already been registered. To do this simply go to National Directory of medical devices and do a search. The certificate of registration of the component should be made payable to producer, who must provide a letter of consent to use of its product by the applicant for registration.
After obtaining the certificate of registration of medical devices will provide the declaration of conformity GOST R, and where predicted, also the Customs Union hygienic registration certificate.
If the medical device is provided with the tools of weight or measure (gauges, thermometers, and various sensors) you will also get the metrological certificate.
 Summary outline of the registration procedure (ITA 72 KB)
Normative References
The registration of medical devices is governed by the administrative regulation introduced by the Ordinance No. 735 of 30/10/2006 of the Ministry of Health of the Russian Federation.
Ordinance of the Ministry of Health of the Russian Federation n. 735 of 30/10/2006 (ENG 574 KB)
Ordinance of the Ministry of Health of the Russian Federation n. 735 of 30/10/2006 (RUS 339 KB)
Categories of risk and classification of medical devices (RUS 773 KB)
Classification of medical devices (RUS 550 KB)
Lists of istitutions authorized to carry out tests (RUS 153 KB)
Guide to the preparation of the practice of registration (RUS 153 KB)
Types and validity of the certificate
The certificate can be issued to the producer who is the importer, for the mass production of devices for playing or for a single device. If the certificate is issued to the producer is valid indefinitely.
Documents required
1) product HS code
2) device data sheet
3) guide, handbook, instructions for use
4) certificate of registration in the register of companies *
5) certificate of free sale issued by the Ministry of Health*
6) quality certificates:
- certified ISO 9001:2000 and / or ISO 13485:2003 *
- certificate / declaration of conformity CE 93/42 * (for reagents and analyzers EC 98/79)
7) test reports:
- ISO 10993 biocompatibility
- general safety standards IEC601-1
- electromagnetic Compatibility - 601-1-2
8) for every signle case may be required additional documentation
9) power of attorney with notary's authentic of the legal representative signature*
* The original documents must be submitted. The certificates issued by public bodies should be legalized in accordance with the Hague Convention of 10.05.1961, by affixing a stamp "Apostille" on the original documents at the Prefecture for the area of residence the applicant.
The certificate of free sale issued by the Ministry of Health should be legalized at the prefecture of Rome. Alternatively, you can authenticate copies of the certificate in the municipality of residence of the applicant and legalized by the local prefecture. The certificate of free sale of the Ministry of Health is normally issued within 30 days.
The Apostille must be required for the prosecution of civil status office of the Prosecutor's Office responsible for the area of residence of the notary.
All copies of documents must bear the stamp and signature of legal representative. All documents must be duly translated into Russian by a sworn translator.
Release times and costs
Testing at or near the production site inspection: un to 30 days.
First issue: up to 4 months
Upgrading: up to 2 months
Fee for single certificate: 71.50 euro
Various tests depending on the risk class of the device made only by a federal laboratory (state runed companies: ФГУ ФГУП), preparation and drafting of the documentation to be sent to the Ministry of Public Health and Social Development for the registration of the device and issue the certificate: euro min. 1,200 - 10,000 max
In the event of a site inspection at the manufacturer, the above mentioned costs must be added the cost of travel, meals and lodging, visa, min. 2 expert 3-4 days. + Interpreter.
Check on-line state of the practice
To check the status of your file (click here)
Enter the number and the date of the application that you have been notified.
Where and when
Federal Service on Surveillance in Healthcare and Social Development
Headquarters: Moscow 109074, Slavjanskaja ploshad, 4 building 1. Tel: +7 495 6983098
Wednesday: 10:00 to 12:45, 14:00-17:00
Friday: 10:00 a.m. to 12:45 p.m., 2:00 p.m. to 4:00 p.m.
The registration of medical devices is a fairly complex procedure, which in addition to an excellent knowledge of bureaucratic procedures, requires specific knowledge in the medical field. Therefore, we recommend contacting qualified service personnel. We are always at your disposal for any further questions or need information.
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