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15 10, 2023

The Ministry of Health has updated the rules for registration of medical devices

October 15, 2023|Categories: registration|Tags: , |

The Ministry of Health of the Russian Federation has made amendments to the document developed this spring on a new procedure for registering medical devices, which [...]

4 10, 2023

The Ministry of Health proposed to register scarce medical devices electronically

October 4, 2023|Categories: registration|Tags: |

The Ministry of Health of the Russian Federation has made a proposal to transfer the procedure for registering medical devices (MD) into electronic form. For now, changes [...]

6 06, 2023

Approved the procedure for the use of non-original components for medical devices

June 6, 2023|Categories: registration|

Roszdravnadzor approved the list of documents provided to confirm the safe use of components or accessories in conjunction with medical devices that are not provided for in [...]

27 05, 2023

Medical furniture for field hospitals can now be registered under a facilitated scheme

May 27, 2023|Categories: registration|Tags: |

Last Tuesday, the Interdepartmental Commission approved new amendments to Decree of the Government of the Russian Federation No. 552, according to which items of field medical [...]

20 02, 2023

The procedure for national registration of medical devices at the EAEU level has been extended until 2025

February 20, 2023|Categories: registration|

On February the 13th, the protocol was published on the EAEU portal on the extension of the registration of medical devices according to national rules until [...]

13 02, 2023

The Federal Service for Surveillace in Healthcare has developed a list of necessary data on non-original components for medical devices

February 13, 2023|Categories: registration|

A draft order of the Federal Service for Surveollance in Healthcare was posted on the legal information web-site. The document contains the requirements to the information on [...]

27 01, 2023

423 medical devices have been registered under the accelerated procedure in 2022

January 27, 2023|Categories: registration|Tags: |

According to the Federal Service for Surveillance in Healthcare, last year 423 items of medical devices successfully passed accelerated registration. Of these, 31 products fell under the [...]

21 10, 2022

Prolongation of the transition period to the common rules of medical devices registration is on the ECE agenda

October 21, 2022|Categories: registration|Tags: |

The agreement on the unified principles and rules of trade of medical devices in the EAEU countries is subjected to new changes. The ECE Council decided to [...]

6 10, 2022

National registration of medical devices in EAEU can be prolonged for an unlimited period

October 6, 2022|Categories: registration|

Pandemic, risk of emergency situation and announcement of the state of martial law, as well as possible consequences of sanctions influence the procedure of registration of medical [...]

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