+7(495)665-81-35
+7(843)226-03-63
Medical devices intended for use in the Russian Federation are subject to state registration in accordance with Russian legislation. Registration of medical devices — a serious, time-consuming, multistep process is regulated.
The company «AiLFARMA» will be pleased to advise you and assist in resolving the issues raised.

The package of documents for obtaining the registration certificate:



Package I:

1.The power of attorney for the registration of medical devices in the Contractor’s name.

2.The power of attorney from the manufacturer to the Customer’name (apostille), i.e. a copy of the document confirming the powers of the manufacturer’s authorized representative.

3.The documents confirming the registration of the manufacturing company as a legal entity (apostille).

4.The documents confirming the compliance of the medical device manufacture conditions with the international requirements or the requirements of the country of origin  (apostille).

5. The documents confirming the compliance of the medical device with the requirements of the international or government regulations (apostille).

Declaration of Conformity.

Package II  (as amended by Resolution of the Government of the Russian Federation dd. October 17, 2013 N 930):

a) Information on the regulatory documentation for a medical device. The manufacturer’technical file of the products to be registered in accordance with Directive 93/42 or Directive 98/79;

b) The manufacturer’s technical documentation of the medical device;

Product specifications, including materials, data on the packaging, labeling, transportation and storage, clinical trials and medical use in the country of manufacturer.

cThe manufacturers operating documentation of the medical device including instructions sheet and user manual of the medical device, the original with thetranslation in Russian;

d)  Photographic images of the general view of the medical device with the accessories needed for use of themedical device as intended (the size shall be at least 18 x 24 centimeters);

e)  Documents certifying the results of technical tests of the medical device:

-CEEMC test-reports;

-Test-reports (IEC 60601 — 1- Medical electrical equipment);

-Test-reports of the low and high temperatures during transportation and storage;

 -Risk analysis report. The report shall give a list of risks identified during the risk analysis and illustrate how these risks are maintained at an acceptable level.

f) Documents certifying the results of toxicologystudies of the medical device, the use of which requires a contact with the human body.

Validation of sterility if the device is sterile;

g) Documents confirming the medical device test results for the purpose of approval of measuring instruments type  (in respect of medical devices classified as the measuring instruments in the field of the state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Healthcare of the Russian Federation);

h) Review of clinical application, including the table of comparison with analogs

or information material as for the analogs and publications:

Comparative analysis of  «MD name» and registered analogs as  «indicatthe analogs»;

Scientific papers on the use of such MD;

-Data confirming clinical efficiency and safety of medical devices (if available);

-Draft of plan of the medical device clinical trials with the relevant justifying materials (if available).

 

 



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Contacts

Address: c. Moscow, 2-й Syromyatnicheskiy str., д.1
Phone: +7(495)665-81-35
Address: г. Kazan, Pr. Yamasheva 46/33
Phone: 8 (843) 226-03-63 ,
Email:
WhatsApp: +7(495)665-81-35
Skype: ailfarma@mail.ru

AiLFarma - licensing of medicines
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