Introduction of changes to the documents contained in the registration dossier
The circulation of a medical device does not end with the registration procedure, it is only from the stages of the product’s life cycle.
If you have an up-to-date registration certificate issued in Russia, then you need to pay attention to possible necessary changes to the registration dossier, the compliance of the delivered product with the technical and operational documentation contained in the archive of the regulatory body (Roszdravnadzor).
Federal Law No. 532-FZ dated December 31, 2014 provides for administrative and criminal liability for illegal manufacture of medical products, circulation of falsified, poor-quality, counterfeit and unregistered medical products, falsification of documents for medical products or their packaging.
In this article, we will tell you about the reasons and the procedure for amending the documents contained in the registration dossier for medical devices.
In accordance with the law, the Manufacturer is obligated to initiate the amendment procedure no later than 30 working days from the date of change of the relevant data.
Some reasons for making changes require an examination of the documents, as well as tests to confirm the variable or added parameters.
Firstly, let’s focus on reasons that do not require changes.
Changes to the documents contained in the registration dossier not requiring a quality, effectiveness and safety examination of a medical product include:
a) change in information about an applicant, including the information:
– on a legal entity reorganization;
– on a change in the name of a legal entity (full and (if available) abbreviated, including company name), its location address;
– on a change in the name, surname and (if available) patronymic, residence address of an individual entrepreneur and identity document details;
b) change in information about a person in whose name a registration certificate for a medical product may be issued, including the information:
– on a legal entity reorganization;
– on a change in the name of a legal entity (full and (if available) abbreviated, including company name), its location address or the name, surname and (if available) patronymic, residence address of an individual entrepreneur;
c) change in the address of the place of manufacturing (production) of a medical product;
d) change in the name of a medical product in case the properties and characteristics affecting the quality, effectiveness and safety of a medical product have not changed, or its properties and characteristics are improved with the same functionality and (or) mode of function, providing for:
– addition (exclusion) of medical product accessories or change in their name;
– indication, modification and exclusion of a trademark and other means of individualization of a medical product;
– a change in the number of units of a medical product or its component parts, components specified in an annex to the registration certificate;
– indication or exclusion of versions (models) of a medical product;
– change in labeling and (or) packaging of a medical product;
e) a change in the documents validity contained in the registration dossier by the manufacturer (producer) of a medical product;
f) a change in the information about the authorized representative of the manufacturer (producer) of a medical product.
As you can see, the reasons for making changes can be very different, up to changing the validity period of the documents contained in the registration dossier. And these include ISO certificates, and a power of attorney for an Authorized Representative, and a declaration of conformity. In our 18 years practice, there have not yet been cases of claims against Manufacturers of medical devices by regulatory authorities regarding updating dossier documents, but due to such a reason at the legislative level, Roszdravnadzor may quite reasonably demand this from Manufacturers or their Authorized Representatives and such requests must be respond.
Introduction of changes in the technical and operational documentation of the manufacturer (except the cases specified in sub-clause “d”) are made based on the results of a quality, effectiveness and safety examination of a medical product, carried out in a manner analogous to the procedure for a quality, effectiveness and safety examination of a medical product for the purpose of its state registration, in case the registration authority, based on the results of completeness and accuracy verification of the information contained in the submitted documents, founds that the introduction of the indicated changes involves changes in the properties and characteristics that affect the quality, efficiency and safety of a medical product, or improve its properties and characteristics at constant functionality and (or) mode of function of a medical product.
To make the changes in the documents contained in the registration dossier, the applicant (for example, Authorized Representative of Manufacturer) shall submit (send) to the registration authority (Roszdravnadzor) next documents:
a) an application for amending the documents contained in the registration dossier (hereinafter referred to as the application for amendments);
b) a copy of the document confirming the authority of the Authorized Representative of the Manufacturer;
c) documents and information on relevant changes, including documents confirming the changes, as well as in the case of a change in the name of a medical device:
– information about the regulatory documentation for the medical device;
– technical documentation of the Manufacturer for the medical device brought into line with the new name of the medical device;
– operational documentation of the Manufacturer for the medical device (including the instructions for use or the manual for the use of the medical device) brought into line with the new name of the medical device;
– photographic images of the general appearance of the medical device, together with the accessories necessary for the intended use of the medical device;
d) documents of the Manufacturer and (or) organizations carrying out technical tests, toxicological studies, clinical trials (results of relevant tests), confirming that the introduction of the declared changes does not entail changes in the properties and characteristics affecting the quality, effectiveness and safety of the medical device, or improves properties and characteristics while maintaining the functional purpose and (or) the principle of action of the medical device;
e) the original registration certificate (duplicate);
f) list of documents.
We draw your attention to the need for timely changes to the dossier if there are reasons for this, the conformity of the product documentation and the fulfillment of the stated marking requirements.
For our part, we are always ready to assist you in the procedure for making changes, including finalizing documentation, collecting all necessary documents, supporting the required tests in accredited laboratories, submitting documents to the regulatory body, as well as representing the Manufacturer’s interests throughout the life cycle of the medical device.