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Simplified procedure for registration of medical products
Simplified procedure for registration of medical products for the
prevention and control of emergencies
Dear Colleagues,
The government of the Russian Federation in accordance with Decree No. 430 dated April 03, 2020 approved a simplified procedure for registration of medical devices intended for the prevention and control of emergencies.
This list includes:
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Invasive mechanical ventilation devices
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SARS Coronavirus identifying tests
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Personal protective equipment (masks, lab gowns, gloves)
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Thermometers
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Oxygenators
A detailed list of products is attached.
Highlights:
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The registration certificate is issued for a series or batch and is valid until 01.01.2021
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Medical devices that have not passed the conformity assessment are subject to re-registration in accordance with the legislation of the Russian Federation
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The Federal Supervisory Agency for Healthcare gives a positive or negative decision within three business days
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Import of samples and preparation of technical and operational documentation should be arranges in advance to avoid the risk of time loss
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Within 3 business days from the date of import of unregistered medical devices to the Russian Federation, the applicant must send information about the series (lots) of imported unregistered medical devices, including the name of the medical device, quantity, serial number (if available), lot (batch) number, manufacture date, expiry date (life cycle), and address of storage to the Federal Supervisory Agency for Healthcare
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It is allowed to sell single-use medical devices that are not registered in the Russian Federation according to the list provided for in the Annex to this document without obtaining a permit from the Federal Supervisory Agency for Healthcare, if these products are registered in the prescribed manner in the country of origin
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Reusable medical devices imported to the Russian Federation that are not registered in accordance with this document are subject to destruction or export from the territory of the Russian Federation after January 1, 2021
These are the main aspects of the decree that we would like to draw your attention to.
It is possible that in the conditions of a pandemic the Government will expand the list of products specified in the Decree.
The MedExpert team will keep you informed of all changes in the regulatory sphere.
You are welcome to contact us with any further questions:
+7 968 550 30 11
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