Quite often, it's necessary to amend the registration documents for any reason. New facts may be featured in permits only in case of availability of reasonable factors allowing to implement the required procedure.

Not so long ago, clause 37 of the Rules of the state registration of medical products (Order No. 633 dated 05/31/2018) was amended, and this amendment contained the following 6 groups of reasons for introduction of amendments to registration documentation:

If the applicant wishes to introduce the above listed amendments to the registration documents, it's necessary to inform the registering authority about it in time.

For implementation of this procedure, every manufacturer of medical products should prepare a package of documents specified by the legislation. The content of the documentation depends on the cause of necessity of the relevant actions.

1) In the first case, the registration certificate on amendments is submitted

2) The second case requires submittal of the registration certificate of the legal entity the MA will be granted to

3) In the third case, it's necessary to prepare documents and certificates confirming existing of the production site or information about additional production sites

4) In the fourth case, the technical and operational documentation for the medical product is submitted to Roszdravnadzor. In such case, the package of the registration documentation is rather large unlike the other cases and is exactly compliant with the registration dossier submitted while obtaining the marketing authorisation. In the meantime, it's necessary to compare the existing data and the data being entered to confirm that the latter doesn't cause changes of properties and specifications influencing quality and safety of the medical product. Also Roszdravnadzor may request the results of previously conducted tests for confirmation of the information submitted by the applicant

5) In case of changes of expiration dates of the documents comprising the registration dossier, the data confirming such changes is submitted

6) In case new information about the authorised representative of the manufacturer of the medical product has appeared, all the documents concerning this person are submitted to Roszdravnadzor to easily find out and specify the changes which have happened in this case.

The mandatory condition дfor the beginning of the procedure of introduction of amendments to the registration documentation is payment of the state duty. Its value directly depends on the cause of this process. At this stage, the value differs depending on two opposite situations:

1) If correction of the information concerning technical and operational documentation is required, the assessment of quality, efficiency and safety of the medical product is conducted and in accordance with the Russian legislation the payment of the following values is collected:

• ₽20,000.00 (for class 1)
• ₽30,000.00 (for class 2a)
• ₽40,000.00 (for class 2b)
• ₽55,000.00 (for class 3)

2) If the amendments don't require carrying out of the above mentioned assessment, the value of the state duty is now equal to 1,500 rubles.

Procedure of introduction of amendments to the registration dossier is not very time-consuming. Our experts will help you to renew the registration dossier within the optimal period and just in 1.5–2 months after submittal of the application to the registering authority.

We save your time — spend it for something more important!