Registration of medical devices
in Russia and the EAEU, work with registration documents and certificates
About us
The RegMedConsult company has many years of experience in providing consulting services and registration of medical devices. The scope of the company's activities also includes the development of documentation: technical specifications, technical documentation and instructions for use and operating manuals.
Highly qualified employees of the company with extensive experience in the registration and declaration of medical devices will help in choosing a strategy and drawing up a work plan.
Highly qualified employees of the company with extensive experience in the registration and declaration of medical devices will help in choosing a strategy and drawing up a work plan.
About us
The RegMedConsult company has many years of experience in providing consulting services and registration of medical devices. The scope of the company's activities also includes the development of documentation: technical specifications, technical documentation and instructions for use and operating manuals. Highly qualified employees of the company with extensive experience in the registration and declaration of medical devices will help in choosing a strategy and drawing up a work plan.
ACHIEVEMENTS
amendments to registration certificates and registration documents.
Why you should work with us
1
experience in the market of registration of medical services, help us to solve any, even the most complex tasks in their sector.
successful registrations have been carried out by us over the years.
1
> 3 000
2
> 13 years
3
> 5 000
Achievements
amendments to registration certificates and registration documents.
Why you should work with us
experience in the market of registration of medical services, help us to solve any, even the most complex tasks in their sector.
successful registrations have been carried out by us over the years.
1
> 3 000
2
> 13 years
3
> 5 000
SERVICES
Registration of medical devices in Russia
Registration of medical devices is a procedure, the purpose of which is to authorize the circulation of medical devices. After passing the registration procedure for medical devices...
Registration of medical devices in the EAEU
Registration of medical devices within the Eurasian Economic Union (EAEU) takes place in accordance with the Decision of the Council of the Eurasian Economic Commission dated...
Amendments to the registration certificate
Grounds for making changes to the registration certificat. Change in information about the applicant, including information: on the reorganization of a legal entity...
Amendments to registration documents
When changing the information not reflected in the registration certificate, it is necessary to make changes to the registration dossier. This procedure provides for an examination of...
Obtaining duplicate registration certificates
In case of loss or damage of the registration certificate, it is possible to obtain a duplicate of the registration certificate. The amount of the state duty. The state duty for obtaining...
Technical tests
Technical tests – tests to determine the compliance of the characteristics (properties) of a medical device with the requirements of regulatory documentation, technical...
Testing of a medical device for electromagnetic compatibility
If the medical device is electrical, an electromagnetic compatibility (EMC) test is required. The EMC test report may be issued as a separate document or may be included in...
Toxicological studies
Toxicological studies are necessary to assess the biological safety of a medical device. Test laboratories, we cooperate only with accredited...
Clinical trials
Clinical trials are designed and planned systematic studies undertaken, including with the participation of a human subject, to evaluate the safety and efficacy of a medical device...
Services
Registration of medical devices in Russia
When changing the information not reflected in the registration certificate, it is necessary to make changes to the registration dossier. This procedure provides for an examination of...
Registration of medical devices in the EAEU
Registration of medical devices within the Eurasian Economic Union (EAEU) takes place in accordance with the Decision of the Council of the Eurasian Economic Commission dated...
Amendments to the registration certificate
Grounds for making changes to the registration certificate. Change in information about the applicant, including information: on the reorganization of a legal entity...
Amendments to registration documents
When changing the information not reflected in the registration certificate, it is necessary to make changes to the registration dossier. This procedure provides for an examination of...
Obtaining duplicate registration certificates
In case of loss or damage of the registration certificate, it is possible to obtain a duplicate of the registration certificate. The amount of the state duty. The state duty for obtaining...
Technical tests
Technical tests – tests to determine the compliance of the characteristics (properties) of a medical device with the requirements of regulatory documentation, technical...
Testing of a medical device for electromagnetic compatibility
If the medical device is electrical, an electromagnetic compatibility (EMC) test is required. The EMC test report may be issued as a separate document or may be included in...
Toxicological studies
Toxicological studies are necessary to assess the biological safety of a medical device. Test laboratories, we cooperate only with accredited...
Clinical trials
Clinical trials are designed and planned systematic studies undertaken, including with the participation of a human subject, to evaluate the safety and efficacy of a medical device...
Limited Liability Company "RegMedConsult"
123112, Moscow, Testovskaya str., 10, floor 24, room I, room 1, office No. 4102
123112, Moscow, Testovskaya str., 10, floor 24, room I, room 1, office No. 4102
CONTACTS
Limited Liability Company "RegMedConsult"
123112, Moscow, Testovskaya str., 10, floor 24, room I, room 1, office No. 410
123112, Moscow, Testovskaya str., 10, floor 24, room I, room 1, office No. 410
Contacts
NEWS
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