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609, 2022

Medical devices entered into the market should be registered by lots by a special service of the Federal Service for Surveillance in Healthcare

September 6, 2022|Categories: registration|

A new function appeared on the web-site of the Federal Service for Surveillance in Healthcare that is available in the applicant’s personal profile. It [...]

609, 2022

The Government prolonged the confirmation of compliance of manufactured and imported medical devices according to the facilitated procedure for a year

September 6, 2022|Categories: registration|Tags: |

In March, 2022, the Cabinet Council suggested facilitation of the procedure of confirmation of compliance of a group of required goods to make their [...]

109, 2022

Medical devices for in vitro diagnostic will get the production allowance according to accelerated procedure

September 1, 2022|Categories: registration|

The Federal Service for Surveillance in Healthcare is planning to issue allowance for manufacturing of non-registered medical devices for in vitro diagnostic of rare [...]

2708, 2022

New rules of inspection of production of medical devices and medical drugs are accepted

August 27, 2022|Categories: Uncategorized|

The EEC Council has accepted the correctives to the Rules of pharmaceutical inspections established by resolution No.83 dated the 3rd of November, 2016. The new [...]

2708, 2022

License for maintenance of own-made medical equipment becomes mandatory for the manufacturers

August 27, 2022|Categories: Uncategorized|Tags: |

The Resolution of the Government No.2129 dated the 30th of November, 2021, «On acceptance of the Regulations on licensing of maintenance of medical devices» is [...]

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