Medical Product Registration Papers Amendments

We will amend the registration documentation of medical products of Russian and foreign production.

We have more than 10 years of experience in registration of certificates for medical products of Russian and foreign production in the territory of the Russian Federation.

The registration services will be supplied by one of the best experts in this field, possessing the highest degree of competence.

We will carry out the work for a reasonable remuneration, in the optimum time; we will also provide a flexible system of payments.

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The amendments of the registration papers that do not require an examination of the quality, effectiveness and safety of a medical product include as follows:

1	information about the applicant, including the following information:	reorganization of a legal entity; name of the legal entity (full and short, including company name), address; first, middle (if available) and second name, residence address of the sole proprietor, as well as the details of the identity documents;
2	information on a person whom the medical product registration certificate is issued to, including the following information:	reorganization of a legal entity; name of the legal entity (full and short, including company name), address, first, middle (if available) and second name, residence address of the sole proprietor;
3	address of a production site of the medical product;
4	name of the medical product in the event that the properties and specifications affecting its quality, effectiveness and safety have not changed, or its properties and specifications are improved with the same functionality and / or principle of action, providing for as follows:	addition (exclusion) of accessories or change of their name; indication, modification and exclusion of a trademark and other means of individualization of the medical product; number of units of the medical product or its component parts, components specified in the annex to the registration certificate; indication or exclusion of versions (models) of the medical product; labeling and / or packaging of the medical product;
5	the validity of the documents contained in the registration papers amended by a manufacturer (producer);
6	information about the authorized representative of the manufacturer (producer) of the medical product.

If the amendments do not require an examination of the quality, effectiveness and safety of the medical product, the following documents shall be submitted:

1	An application for state registration of the medical product,
2	A copy of the document confirming the authority of the representative (manufacturer);
3	Information about the regulatory documentation for the medical product;
4	Technical documentation of the manufacturer;
5	Operational documentation of the manufacturer (s), including instructions for use or manual to the medical product;
6	Photographic general images of the medical product, along with the accessories necessary for the use of the medical product for its intended purpose (at least 18 x 24 centimeters in size);
7	Documents confirming the results of technical tests of the medical product;
8	Documents confirming the results of toxicological tests of the medical product, the use of which implies contact with the human body;
9	Documents confirming the test results of the medical product for the purpose of approving the type of measuring instruments (for medical products related to measuring instruments in the state regulation of ensuring the uniformity of measurements, the list of which is approved by the Ministry of Health of the Russian Federation);