Registration of medical devices
The
state registration of medical products, the registration of medical
equipment - a procedure to validate compliance with product requirements
imposed by the Russian legislation to the medical products. It
can be both qualitative characteristics of products and safety
performance to be met or delivered manufactured products in Russia.
Need
to make clear the procedure for registration of medical devices is not
easy and requires knowledge of legislation, regulations governing the
quality and safety in this area.
Thus,
the registration of medical devices is carried out to their admission
to the manufacture, importation, sale and use in the Russian
Federation. And also to ensure the quality, efficacy and safety of manufactured products. Accordingly, if you do not have a registration certificate for medical devices will not be able to operate on our territory.
In
this case, we must remember that the registration of medical devices is
carried out based on the results of testing and assessment, certifying
the quality, efficacy and safety products. Without them, it is impossible to obtain a registration certificate for medical equipment. Just note that the law stipulates the extension of review of the documents in the case of additional testing and evaluations. Thus, the registration certificate for medical equipment you can get a view of that period.
The state registration of medical products made in the name of the entity or individual entrepreneur. In doing so, the Russian and foreign products are presented the same demands.
Registration certificate for medical devices confirms that the applicant passed the registration of medical products. Today, its duration is unlimited. Previously, he was 5 and 10 years. Registration of medical devices with expired carried out in accordance with applicable laws and regulations. The document, which confirms the fact of registration, registration certificate is also Roszdravnadzor.
Here
are the main criteria on which the registration certificate for medical
equipment and medical products can not be obtained.
Registration
of medical devices is carried out in accordance with administrative
regulations of the Federal Service on Surveillance in Healthcare and
Social Development, the violation of such requirements as:
1) The completeness, the composition of the documents and data or the incompetence of the registration application;
2) submission by the applicant of false or invalid information about medical products;
3)
obtain an expert opinion about the insecurity and the ineffectiveness
of either not been proved safe and effective medical devices in the
event that it is received from at least two independent experts and
evidence:
- The risk of higher than expected product performance;
- Insufficient evidence of effectiveness;
- A mismatch of information contained in the documents submitted for registration, the actual state.
By contacting us you can be assured that we will help you gather the correct documents for registration of medical products.
In
addition, we assure that the registration of medical devices and
registration of medical devices will be passed in time, clearly defined
by law.
As
a result, you will receive a registration certificate Roszdravnadzor
and can freely carry out activities to the benefit of the Russian
Federation.
Performance time of 2 months.
Cost of services:
1. Our fees are calculated individually, depending on the risk class of medical products.
2. Official Payments (government duty, trial and imprisonment)
Additional services:
1. Alignment and / or develop specifications for medical devices
2. Getting the declaration of conformity
3. Obtaining voluntary certificate