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:
- Change of information about the applicant (legal entity, individual entrepreneur)
- Change of information about a person in whose name a registration certificate can be issued
- Change of production address
- Changing the name of a medical device (if its properties and characteristics that affect quality and safety have not changed, or if the properties and characteristics are improved, but the functional purpose of the product and the principle of its operation remain unchanged
- Changing the validity period of documents from the registration dossier
- Change of information about authorized representatives of the manufacturer of the product
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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