The registration of medical devices in the Russian Federation is carried out in accordance with the established rules. This includes the registration itself, replacement and issuance of copies of registration certificates, making changes both to the registration certificates and to the registration documentation for the medical device. There are many reasons for which changes can be made, and we will consider them in detail below.
The registration documentation will be examined depending on the reason for which changes are required. However, the application for variations may be considered by the competent bodies without expert examination.
Changes in Registration Documentation without Expert Examinations
You will find detailed information on what changes can be made without performing an expert examination in another section of our website:
The initial category of modifications relates to the applicant’s data. This may include a change of name, a change in the legal entity’s address, a change of personal data for the applicant, a change of residence, or changes to the documentation certifying the applicant’s identity. Furthermore, amendments to the registration documents may be made in the event of a change of address for the production of medical devices or when it is necessary to change the name of the device. However, this is only permitted if all properties and characteristics of devices are maintained.
Please advise if you require a change of name for a medical device. Or do you require assistance with exclusion, marking, or replacement of the marking or trademark? Or perhaps you require an amendment to the number of units and names?
All these changes are possible without expert examinations. Changes without expert examinations are possible if certain conditions are met, namely:
- There is no impact on the properties, quality and characteristics of the device;
- The principle of its operation as well as its purpose remains unchanged.
In all other cases, amendments to registration documents are made following a comprehensive review and analysis of the revised documentation. This entails a thorough assessment of the quality, safety and efficacy of the medical device in question.
What Changes to the Registration Documentation Require an Expert Examination?
This category encompasses all modifications pertaining to alterations in the device configuration, its marking and packaging, the use of new materials in the manufacturing process, and a multitude of variations to the technical and operational documentation for the medical device. Furthermore, the timeframe for implementing changes is longer than that for making changes without an expert examination.
This is how you submit documentation for changes
Making changes to registration documents that require an expert examination has a number of specific features.
Let’s take a closer look at the issue of collecting the required package of documents. So, the applicant shall submit the following documentation to Roszdravnadzor (within 1 calendar month):
- Application for permission to make changes to documentation;
- A check or payment order confirming the fact that you have paid the state fee;
- A package of documents that serves as confirmation of the changes being made.
It is not uncommon for applications to be filled out incorrectly or for packages of documents to be incomplete. Before filling out the application, it is essential to familiarize yourself with the application form, which is fixed by state regulations. If you make a mistake or provide an incomplete package of documents, you can update this. You have 30 days to re-submit the application and update any inaccuracies or errors.
Please note that the submitted documentation shall be certified by authorized bodies in the manner established by the country of manufacture. If the documentation is provided in a foreign language, a notarized translation is required.
Once you have submitted your document package, you will receive a written response from Roszdravnadzor. The body makes a decision based on the information provided: either to allow changes or to refuse. The cover letter clearly sets out the reasons for refusal.
Key points for Making Changes to Registration Documentation
To avoid any Problems when Submitting your Application, you Should Always Remember a Few Important Points:
- Amendments to the registration documentation for a medical device shall be made within 1 month after they are accepted. Roszdravnadzor shall be informed of the preparation of documents in connection with the changes made by the manufacturer;
- All tests and studies of the modified medical device shall be conducted and the results submitted to Roszdravnadzor along with an application to amend the registration documentation. These tests are necessary to confirm the quality, safety and effectiveness of the device;
- Errors and violations must be corrected within 30 days of identification. If this is not done, the application will be returned to the applicant and a detailed, reasoned explanation of the decision taken will be provided.
The statistics are clear: the most common violations and reasons for returning documents for revision are failure to indicate all reasons for making changes, submission of an incomplete set of documents, and failure to submit an application in the correct form.
Do it Yourself or Ask for Help?
As previously stated, amending the registration documentation is a complex and time-consuming process. While it is possible to prepare the documentation independently, this approach may result in delays due to the potential for errors and shortcomings, which require time-consuming correction. Therefore, it is advisable to engage the services of professionals to ensure efficient and timely completion of the task by experts in the field.
Our company offers professional services to facilitate the process of updating the registration documentation of medical devices with authorized bodies.
We provide a Comprehensive as Well as a Selective Range of Services Offering as Follows:
- We provide the most detailed consultations;
- We provide detailed instructions on how to properly prepare a package of documents;
- We prepare and conduct all necessary expert examinations and research;
- We prepare and draw up all the necessary documentation to form a registration dossier for a medical device;
- We provide full support;
- We help in obtaining a registration certificate and much more.
This is only a small part of the services we provide. You can find a full and detailed list on the company’s website.
Why Should you Use Our Services?
It is quite easy to use our services! All you need to do is to contact our specialists, discuss the terms of cooperation and ask questions. Experienced managers will be happy to advise you.
Contact specialists by calling the numbers listed on the website or using the “Order a call” service.