Services for Chinese manufacturers

We provide a full range of business support services in Russia:

We provide Authorized Representative services in the Russian Federation and the EAEU countries.

We'll draw up a contract in RMB with the option of payment from China.

We import samples for testing – we will pay duties, organize logistics, issue import permits, and clear them through customs.

We register your products according to national and EAEU procedures – a full range of services from document preparation and testing to the creation of a registration dossier and inclusion in the state register of medical devices.

We cooperate with government executive authorities regarding the circulation of your medical devices in the Russian Federation and the EAEU countries.

We prepare and provide support to the manufacturer during the audit of the production quality management system by the Expert Organizations of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) (mandatory for manufacturers of medical devices of risk classes 2a sterile, 2b and 3)

We prepare a post-registration clinical monitoring plan, assist in collecting clinical data from healthcare facilities across the Russian Federation, and prepare an annual report for the Federal Service for Surveillance in Healthcare (Roszdravnadzor) (mandatory for medical devices with potential risk class 3, as well as medical devices implanted in the human body with potential risk class 26).

Need a consultation?

Request a free consultation on the registration procedure  and ask all your questions.

It's important to us to make working with our clients comfortable and effective, so we adhere to the following principles:

Professional approach

Our staff includes experts with proven experience in the field of medical device registration;

Transparent planning

We develop a detailed registration plan in
collaboration with the manufacturer or authorized representative… More

Open pricing policy

We provide clear and transparent pricing.

Flexible cooperation format

We provide both full turnkey support and individual stages
of the registration process;