STATE REGISTRATION OF MEDICAL DEVICES
Customer orientation, responsibility, speed and highest quality of services
Individual and integrated approach
High professionalism
The speed of service provision in compliance with all obligations
| ABOUT US Our company is relatively young: we have been working in the market of registration of medical devices and equipment since 2021. During this period, we were able to earn the recognition of many foreign and domestic companies who appreciated the high quality of our services. Our experts are experienced professionals who understand how important it is for our clients to get advice on risk assessment when registering products, solve problems arising in a rapidly changing financial situation and issue permits without delay. Toxicological, technical and clinical tests, preparation of technical documentation – this is not the whole range of services that we offer to customers. Clients trust us with serious projects. Carefully analyzing the wishes of customers, we are constantly improving the quality of our work. An integrated approach, impeccable compliance with deadlines and obligations, as well as maximum comfort for our customers are the main principles of our company. |
VIVAMED – YOUR CONFIDENCE IN QUALITY
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SERVICES
Our team of highly qualified specialists will solve the most difficult issues and provide timely assistance and support for the registration of medical devices
State registration of medical devices is a mandatory procedure. It is necessary in order to produce only high-quality and safe medical devices on the market. The passage of the procedure is a prerequisite for the import, use, sale, as well as the production of medical devices. For example, a distributor plans to import medical equipment from a foreign manufacturer to Russia. In this case, according to the law, he must go through the registration procedure, and then sell or use this equipment on the territory of Russian Federation.
A registration certificate - is a document for a registered medical device. It confirms that the product can be manufactured, imported, sold and used in Russia. The registration certificate is issued by the Federal service for surveillance in Healthcare.
The registration dossier for a medical device is a package of documents required for state registration.
The registration dossier is formed from the following documents:
A registration certificate - is a document for a registered medical device. It confirms that the product can be manufactured, imported, sold and used in Russia. The registration certificate is issued by the Federal service for surveillance in Healthcare.
The registration dossier for a medical device is a package of documents required for state registration.
The registration dossier is formed from the following documents:
- application for registration
- document confirming the authority of the authorized representative of the manufacturer (power of attorney)
- information about the regulatory documentation for the medical device
- the manufacturer technical documentation for device (including the risk management file)
- the manufacturer operational documentation for device
- photos of the medical device
- results of clinical, technical and toxicological trials
- documentary confirmation of the implementation of the quality management system from the manufacturer. ISO 13485
- information about the payment of the state fee (the amount depends on the class of potential risk of the medical device)
- The list of documents may vary depending on the risk class of the product.
is preparation of the necessary documentation in accordance with the requirements of legislation for the successful completion of state registration. Clients turn to us in order to avoid mistakes and waste of time. Experienced experts of the company will develop or finalize the existing documentation for further state registration.
Technical trials:
Our group of companies includes a laboratory accredited in accordance with the legislation of the Russian Federation to conduct technical trials in the frames of state registration of medical devices.
Toxicological studies of medical devices:
we have our own laboratory for conducting toxicological studies of medical devices.
Clinical trials of medical devices:
our specialists will select a clinical laboratory for conducting clinical trials in the shortest possible time, taking into account your wishes and capabilities.
Electromagnetic compatibility tests:
our specialists will select a laboratory for conducting electromagnetic compatibility tests as soon as possible, taking into account your wishes and capabilities.
Our group of companies includes a laboratory accredited in accordance with the legislation of the Russian Federation to conduct technical trials in the frames of state registration of medical devices.
Toxicological studies of medical devices:
we have our own laboratory for conducting toxicological studies of medical devices.
Clinical trials of medical devices:
our specialists will select a clinical laboratory for conducting clinical trials in the shortest possible time, taking into account your wishes and capabilities.
Electromagnetic compatibility tests:
our specialists will select a laboratory for conducting electromagnetic compatibility tests as soon as possible, taking into account your wishes and capabilities.
The authorized representative of the manufacturer on the territory of the Russian Federation is an organization or individual entrepreneur who are residents of Russia and authorized, in accordance with the power of attorney of the manufacturer of a medical device, to represent his interests and take responsibility regarding the circulation of a medical device in the Russian Federation and the fulfillment of mandatory requirements for medical devices.
In accordance with the requirements of the Rules of State Registration of Medical Devices all foreign manufacturers of medical devices in circulation in Russia must have an authorized representative. The presence of an authorized representative of a foreign manufacturer is a prerequisite for the legal circulation of medical devices on the territory of the Russian Federation.
Based on the definition of the authorized representative, it follows that it is responsible for the circulation of foreign-made medical devices on the territory of the Russian Federation and there is a need to carry out procedures established by regulatory acts. Main functions and responsibilities of the authorized representative:
In accordance with the requirements of the Rules of State Registration of Medical Devices all foreign manufacturers of medical devices in circulation in Russia must have an authorized representative. The presence of an authorized representative of a foreign manufacturer is a prerequisite for the legal circulation of medical devices on the territory of the Russian Federation.
Based on the definition of the authorized representative, it follows that it is responsible for the circulation of foreign-made medical devices on the territory of the Russian Federation and there is a need to carry out procedures established by regulatory acts. Main functions and responsibilities of the authorized representative:
- implementation of work on registration of medical devices and timely amendments to existing registration documents;
- interaction with consumers of medical devices on their quality, safety and effectiveness;
- interaction with Roszdravnadzor in case of adverse events related to the treatment of a medical device;
- interaction with the manufacturer in order to obtain the necessary documents, information and other resources necessary to comply with the requirements of the legislation of the Russian Federation regulating the circulation of medical devices.
Without expertise:
Changes that do not require an expertise of the quality, effectiveness and safety of a medical device in accordance with Registration Rules include:
With expertise:
The examination is mandatory in cases where the introduction of the claimed changes entails a change in the properties and characteristics affecting the quality, effectiveness and safety of a medical device, or improves its properties and characteristics while the functional purpose and (or) the principle of operation of the medical device remains unchanged.
Therefore, expertise is required when making changes to:
Changes are made based on the results of the expertise of the quality, effectiveness and safety of a medical device.
Changes that do not require an expertise of the quality, effectiveness and safety of a medical device in accordance with Registration Rules include:
- change of information about the applicant, including information
- about the reorganization of a legal entity;
- on changing the name of the legal entity (full and (if available) abbreviated, including the company name), the address of its location;
- about the change of the surname, first name and (if available) patronymic, address of the place of residence of the individual entrepreneur and the details of the identity document;
- change of information about the person in whose name a registration certificate for a medical device can be issued, including information
- about the reorganization of a legal entity;
- on changing the name of the legal entity (full and (if available) abbreviated, including the company name), the address of its location or surname, first name and (if available) patronymic, place of residence of the individual entrepreneur;
- changing the address of the place of manufacture (manufacture) of a medical device;
- changing the name of a medical device if the properties and characteristics affecting the quality, effectiveness and safety of a medical device have not changed, or its properties and characteristics are being improved with the functional purpose and (or) the principle of operation unchanged, providing for:
- adding (excluding) accessories of a medical device or changing their name;
- indication, modification and exclusion of a trademark and other means of individualization of a medical device;
- changing the number of units of a medical device or its components, components specified in the appendix to the registration certificate;
- indication or exclusion of variants (models) of a medical device. That is, not adding a new version, but bringing information about what is already available in the documentation (for example, specifying information in the form of the RU);
- changing the labeling and (or) packaging of a medical device;
- modification by the manufacturer (manufacturer) of the medical device of the validity period of the documents contained in the registration dossier;
- change of information about the authorized representative of the manufacturer (manufacturer) of the medical device.
- To make changes that do not require examination, the applicant submits documents and information to Roszdravnadzor no later than 30 working days from the date of the change of the relevant data. If the documents are written in a foreign language, they must be translated into Russian (the translation must be certified). The term of rendering the service for making changes to the registration certificate.
With expertise:
The examination is mandatory in cases where the introduction of the claimed changes entails a change in the properties and characteristics affecting the quality, effectiveness and safety of a medical device, or improves its properties and characteristics while the functional purpose and (or) the principle of operation of the medical device remains unchanged.
Therefore, expertise is required when making changes to:
- adding (excluding) accessories of a medical device or changing their name;
- indication, modification and exclusion of a trademark and other means of individualization of a medical device;
- changing the number of units of a medical device or its components, components specified in the appendix to the registration certificate;
- indication or exclusion of variants (models) of a medical device;
- changing the labeling and (or) packaging of a medical device;
Changes are made based on the results of the expertise of the quality, effectiveness and safety of a medical device.
- assessment of compliance of the management system with the requirements of the standard ISO 13485
- revision of the existing management system to meet the requirements or creation of a new management system
- preparation for external audit
- obtaining a permission for import of medical device in the purpose of state registration
- preparation of letters/requests/answers to the regulatory bodies
- preparation for licensing in the field of technical Maintenance and production of medical devices
EVENTS
CAREER
We invite specialists to join our team. We value independence, reasonableness of actions and interest in development in the field of circulation of medical devices.
We offer ambitious interesting tasks, training and development, official employment, an office in the center of Moscow.
You will be able to become part of a great team with a healthy sense of humor and democratic leadership.
A nice bonus: a friendly atmosphere, coffee buns, the most creative fun corporate parties and other small joys of office life.
CONTACTS
We will answer all tour questions with pleasure
Phone
+7(495)799-06-16 (ext.116)
Email
info@vivamed.info
Address
Prospekt Mira st., 39, b. 2, floor 4
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