Amendments to the registration documents of medical devices
After the launching medical device in the Russian market, a new important task emerges, consisting in keeping the registration dossier up to date, in accordance with the current legislation on the circulation of medical devices.
Medical devices are constantly being developed and improved: new models appear in the model range, accessories will expand, documents with a validity period will end, and product design will be updated. All changes, including those that seem insignificant and unimportant, are required to be legalized by making changes to registration documents.
The following changes have to be made in accordance with Russian legislation:
- on the applicant and / or the person in whose name the registration certificate for the medical device have been issued;
- addresses of the place of production (manufacture) of the medical device;
- names of the medical device (with the same properties and characteristics);
- names of the medical product / documents of the registration dossier (when the properties and characteristics change);
- information when the manufacturer (manufacturer) of the medical device changes the validity of the documents contained in the registration dossier;
- information on the authorized representative of the manufacturer (manufacturer) of the medical device.
To make changes to the Federal Service for Surveillance in HealthCare (Roszdravnadzor), the following is provided:
- application for amendments to the documents contained in the registration dossier;
- power of attorney for the manufacturer's representative;
- documents and information on relevant changes;
- documents confirming that making changes does not entail changes in the properties and characteristics affecting the quality, effectiveness and safety of the medical product, or improves the properties and characteristics with the same functionality and (or) principle of operation of the medical device;
- original registration certificate (duplicate);
- list of documents.
Also, despite the careful preparation of documents, applicant must be prepared to receive requests from the registering authority. Requests sent by the Federal Service for Surveillance in Healthcare require adequate responses in the manner and time specified by law. Missing these deadlines threatens to refuse to register products.
The provision of services for the introduction of these changes falls within the competence of BRACE Law Firm. The amount of changes depends on the number of documents and information in respect of which the update of documents and information of the registration dossier is required.
In the absence of timely updating of the registration dossier during the inspection of selected samples in circulation, there is a risk of recognizing the illegality of the circulation of medical products, suspension of circulation of a batch of products and bringing the violator to legal responsibility.
The services of the Law firm BRACE in the field of amending the registration documents of a medical device include:
- Change of information about the applicant / change of information about the person in whose name a registration certificate have been issued for a medical device.
- Changing the address of the place of production (manufacturing) of a medical device.
- Changing the name of the medical device (with unchanged properties and characteristics).
- Changing the name of the medical product / documents of the registration dossier (when changing properties and characteristics).
- Change by the manufacturer (manufacturer) of the medical device of the validity of the documents contained in the registration dossier.
- Changing information about the authorized representative of the manufacturer (manufacturer) of the medical product.
At the same time, we also provide the following services:
- Support of the registration of a permit for importing a medical device into the territory of the Russian Federation for the purpose of registration;
- Preparation of an application for state registration of a medical device;
- Assistance in the preparation and/or verification of technical and operational documentation in accordance with legal requirements;
- Support of technical, toxicological tests, electro-magnetic compatibility of medical devices (EMC) (if necessary);
- Forming a dossier, checking the completeness of documents;
- Accompanying clinical trials;
- Consultation on the registration of medical products