Amendments to registration documents
When changing the information not reflected in the registration certificate, it is necessary to make changes to the registration dossier.
This procedure provides for an examination of the quality, efficacy, and safety of a medical device, depending on the class of potential risk of its use in accordance with the nomenclature classification of medical devices approved by the federal executive body responsible for the development and implementation of state policy and legal regulation in the field of healthcare.
This procedure provides for an examination of the quality, efficacy, and safety of a medical device, depending on the class of potential risk of its use in accordance with the nomenclature classification of medical devices approved by the federal executive body responsible for the development and implementation of state policy and legal regulation in the field of healthcare.
Making changes to documents:
The amount of the state duty:
The state duty for making changes to the documents contained in the registration dossier of a medical device that do not require an examination of the quality, effectiveness and safety of the medical device is 2 500 rubles.
State duty for conducting an examination of the quality, efficacy and safety of a medical device when making changes to the documents contained in the registration dossier of a medical device:
State duty for conducting an examination of the quality, efficacy and safety of a medical device when making changes to the documents contained in the registration dossier of a medical device:
- Class 1 – 32 000 rubles;
- Class 2a – 48 000 rubles;
- Class 26 – 64 000 rubles;
- Class 3 — 104 000 rubles.*
Cost calculation:
The list of information required to calculate the cost of registering a medical device:
- Name of the medical device;
- Purpose and scope;
- Specifications;
- The materials from which the medical device is made;
- Analogues registered in the Russian Federation.
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