One frequently asked question is why changes can be made to registration certificates for medical devices. There are a number of reasons for this, which we will examine in detail below. Some changes require a special examination of the safety, quality and effectiveness of medical devices, while others are made without additional expert examinations.
In the first instance, where no expert examination is required, the following changes can be made:
- Information about the applicant, such as corporate restructuring, change of name, as well as change of location address;
- Change of personal data of the applicant, if it is an individual entrepreneur (surname, name, patronymic, address of residence, change of identity documents);
- Change of the place of manufacture of the medical device;
- Change of the name of the medical device (but only if there are no changes in the properties and characteristics of the medical device). In such a case, the following changes could be considered:
- 1. Changes related to the trademark (its removal, replacement, etc.).
- 2. Addition or, conversely, removal of medical device accessories.
- 3. Change of markings.
- 4. Change in packaging of a medical device.
- 5. Inclusion or exclusion of certain models of medical devices.
- 6. Replacement of the number of units of medical devices.
- 7. Changing the validity period of device documents.
- 8. Change of data of the manufacturer's authorized representative.
It is important to note that amendments to registration certificates may only be made in cases where they do not affect the characteristics and properties of the products in question, and thus do not impact their safety, effectiveness or quality.
In cases where expert examinations are required, amendments to the registration certificate are permitted only after the results of the safety, effectiveness and quality examinations have been received. Please be advised that all changes must be notified to the authorized bodies no later than one calendar month as from the date of their entry into legal force.
The Following Stages are involved in Making Changes to the Registration Certificate:
The procedure is comprised of several stages:
The initial stage involves a comprehensive examination of the documentation provided for the device. Subsequently, the package of documents is revised and the requisite information is produced in consideration of the requisite alterations. It is important to note that a letter outlining the nature of the changes being made shall be included with the package of documents. This letter is a mandatory requirement, irrespective of the nature of the changes. Please be advised that this information can only be provided by the manufacturer.
Submission of a package of documents for a medical device to the Federal Service for Supervision of Healthcare. If the package of documents is collected completely and correctly, and the application is also correctly drawn up, then the period for making changes to registration certificates does not exceed fifteen days (if there is no need for an expert examination). If an expert examination is necessary, this period reaches 50 days. In this case, applicants are given the opportunity to eliminate comments within another fifty days.
Please advise Which Documents are Required when Making Changes?
In case it is necessary to introduce changes about the applicant, it is necessary to prepare the following documents: a letter confirming the fact that the changes will not affect the quality characteristics, a certificate of registration of a foreign manufacturer, a power of attorney for a Russian company, data from the manufacturer confirming the changes to be made, ISO 13485 quality management system certificates and CE certificate. Exactly the same package of documents is required when the address or place of production is changed. When the name of the product is changed, the declaration of conformity, CE and free market certificate, technical files, product photos, and the user manual should be attached to the above package of documents.
Should you require amendments to be made to the registration certificate for a medical device, there are a number of ways in which this can be achieved. The first of these is to complete the process yourself. However, it is important to note that this is a time-consuming procedure and you may have to spend a significant amount of time gathering the necessary documentation and submitting applications.
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Our team comprises highly experienced specialists with extensive work experience. They maintain their qualifications to the highest standards, participate in numerous training and conference programs, and are therefore always fully informed of new innovations, legislation and other developments.
We understand and accept full responsibility for our activities. When you contact us, you can be confident that we will complete the work efficiently and in timely manner. We have established strong partnerships with numerous major medical institutions and scientific centers. We have also received a number of registration certificates, as well as various other certificates and licenses.
Our website provides comprehensive information about the full range of services we offer. Furthermore, you can view a list of our esteemed clients, which includes many of the companies that have placed their trust in us and have become our regular customers.
Issues related to the registration of medical devices, along with any subsequent amendments, declarations and licensing, are a complex and time-consuming process. For instance, the collection and submission of documents may vary depending on the intended purpose and the required format. This often causes confusion and delays the process.
We would like to suggest contacting our company specialists as an excellent solution to this problem. Our team will be able to resolve your issue in a timely and efficient manner. We guarantee that the work will be completed within the agreed timeframe, without any delays or issues.
How to start co-operation with us? It is a straightforward process. Should you require further information, please do not hesitate to contact us by telephone on the numbers listed on the website. Our managers and consultants will be happy to answer any questions you may have. Additionally, customers have the option to request a “callback” service.
We sincerely hope that, having contacted us once, you will be satisfied with the results of our cooperation and become our regular customers.
MedReg Consulting company’s goal is to streamline your processes and make your life easier!