Amendments to the registration certificate of Roszdravnadzor
Amending a registration certificate is a procedure that involves changing any data in a previously issued registration certificate for a medical device.
Grounds for amendments to the certificate of registration:
- Change of information concerning the applicant of the marketing authorization:
- Change of legal entity;
- Change of the name of the legal entity (full or abbreviated)
- Change of address (location) of a legal entity;
- Change of surname or first name; address of the place of residence of the individual entrepreneur, and the details of the document proving his identity.
- Change of the address of production of a medical device;
- Change of the brand name of a medical device;
- Specifying the type of medical product according to the nomenclature Classification of medical devices (in his absence).
Documentation required to amend the registration certificate of Roszdravnadzor:
- Application for amending the registration certificate in the form (sample);
- Current reference to the USRLE (tax site);
- A copy of the document confirming the authority of the authorized representative of the manufacturer (manufacturer);
- Number of the registration dossier;
- In case of changes in the information about the applicant, as well as the place of manufacture of the medical device — documents confirming such changes;
- In the event of a change in the name of a medical device: information about the regulatory documentation for the medical device, technical documentation of the manufacturer (manufacturer) for the medical device, brought in line with the new name of the medical device; manufacturer’s (manufacturer’s) operational documentation for a medical device, including instructions for use or operating instructions for a medical device, brought in line with the new name of the medical device; photographic images of a general view of a medical device along with accessories necessary for the intended use of the medical device (at least 18 × 24 centimeters in size).
- List of documents (sample).
Please note that the above list is exemplary, and is not regulated by specific instruments, and presented solely for the purpose of explanation of what documents may be taken into consideration. A complete list of documents is determined individually for each procedure, amendments to the registration certificate!
The main stages of amending the registration certificate of Roszdravnadzor:
- Drawing up an application and an inventory on amending the registration certificate;
- Collection, analysis, revision, and, if necessary, translation of all necessary documentation (translators work at Goszdravnadzor);
- Sending official requests with further receipt of a letter from the manufacturer confirming that changes in the registration certificate do not entail changes in properties and characteristics that affect the quality, effectiveness and safety of a medical device;
- Payment of state fees;
- Submission of the collected package of documents together with a receipt for payment of the state fee to Roszdravnadzor;
- Accompanying the process of making changes to the registration certificate and obtaining the original document;
- Transfer of a set of documents together with new documentation to the customer.
Experts who are ready to solve your problem:
- Project manager for work with clients and his assistant,
- Specialist in the development of documentation and his assistant,
- Testing expert (technical, toxicological and clinical trials),
Here you can see the full price list for our services.
Since 2011, Goszdravnadzor has been professionally engaged in the provision of services for the registration of permits. During our activity, we managed to study this direction down to the smallest nuances. Today we can confidently declare that we are one of the leaders in the development and execution of permits.
Benefits of cooperation with Goszdravnadzor:
Command with a common goal
The Goszdravnadzor company as an organism united by a common goal — to do the work so that the client is satisfied, turned to us again, and advised colleagues. An optimally selected staff of employees successfully resolves any issues during the performance of work, moreover, it does it without involving other performers. The client will not “lose” his project manager, as our staff turnover is minimal.
In words, in a contract and in work
The obvious superiority of Goszdravnadzor over competitors is transparent and honest interaction with the customer. After receipt of the offer, you can be sure that the price and terms of the provision of services in the final there. During the entire period of work, there has not yet been a case when the cost of the work agreed with the customer was overstated or changed. If mistakes are made on our part, we will compensate the costs of correcting them at our own expense. The client makes payment in stages — upon completion of the work.
Guaranteed successful completion of the project
Until the conclusion of the contract, specialists with specialized education conduct a thorough analysis of the available documentation for products or equipment. In the absence of the necessary information, we will certainly notify the customer about this. In this way, we reduce the risk of a negative result and also reduce the turnaround time.
Experience. Knowledge. Authority.
Since 2011, the Goszdravnadzor company has been carrying out projects of varying complexity and focus. We have worked with both simple (one-component) medical devices with a low hazard class and high-tech medical equipment. Extensive knowledge of experts and well-established relations with government agencies allow you to work faster, draw up documentation the first time, and carry out tests without a headache for the customer.