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Changes in RU and RD

Do you need to make changes to an already issued registration certificate or registration dossier? We will take care of the formalities!

We will prepare documents on changes, submit them to Roszdravnadzor and control the successful introduction of changes:

CHANGES TO THE REGISTRATION CERTIFICATE:

Changes that need to be notified to Roszdravnadzor include:

Note! It is necessary to submit documents for making changes to the registration certified within 30 days after these changes have occurred

CHANGES TO THE REGISTRATION DOSSIER:

If a change in the dossier is caused by a change in the properties and characteristics of the product, which affect its quality, efficacy and safety, or if these properties and characteristics are improved, Roszdravnadzor will amend the dossier based on the results of a new examination of the quality, efficacy and safety of a medical device. This examination is carried out in the same way as the one that the product passed during registration.

You will need to pay a state fee for making changes

REPLACEMENT OF REGISTRATION CERTIFICATE:

If you received a marketing authorization for a product before the introduction of a new form of certification, you can replace this certification with a new one. There is no need to pay the state duty.

If the certificate has a validity period, it is valid until the end of this period, regardless of the form. If there is no validity period, you need to get a certificate in a new form before January 1, 2021

DUPLICATE REGISTRATION CERTIFICATE:

If the registration certificate is lost or damaged, you can get a duplicate. For this, an application and payment of the state fee is enough.

If the registration certificate is damaged, the damaged document must be attached to the application

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