Two independent service areas
Profit Pharm supports both stand-alone state registration of medical devices and the comprehensive entry of foreign companies into the Russian market.
Choose your objective
Registration addresses the lawful placement of a medical device on the market. Representation establishes the operational, legal and commercial infrastructure a foreign company needs in Russia.
Choose a service to explore the details
For manufacturers who need to complete the regulatory procedure and ensure that their device meets the requirements of Russian legislation.
For foreign companies seeking comprehensive support to establish a presence, launch operations and develop their business in the Russian market.
Service 01
State registration with the Federal Service for Surveillance in Healthcare (Roszdravnadzor) is the basis for selling a medical device in the Russian Federation.
We support the procedure from initial assessment through obtaining a register entry and addressing post-registration requirements.
Preparing the application, technical, operating and regulatory documentation, as well as packaging artwork, in accordance with Russian legislation.
We select service providers, coordinate samples and documents, and oversee testing and the delivery of results.
We develop the programme and support the organisation of clinical trials for your medical device.
We help prepare documents confirming that manufacturing meets the requirements for implementing, maintaining and assessing a quality management system (QMS).
We provide authorised representative services for manufacturers in the Russian Federation.
We support the process of obtaining an entry in the state register of registered medical devices on the official Roszdravnadzor website.
We prepare documents and support amendments to the registration dossier and registration information.
We prepare monitoring reports, investigate adverse events, develop substantiated positions and prepare responses to Roszdravnadzor.
An independent regulatory track
Registration outcome
Since 2025, the only registration document issued is an extract from the State Register of Medical Devices and Organisations Engaged in Their Production and Manufacture.
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We establish Russian infrastructure for a foreign manufacturer, from assessing the market and partners to providing operational support.
This service can be commissioned independently of registration or combined with the regulatory track.
We identify target segments and regions, and compile a list of potential clients, distributors and partners.
We analyse available legal, financial and business information before contractual work begins.
We support contractual work and represent the company’s interests before government bodies and institutions.
Full or partial outsourcing, tax and business accounting, reporting, support during inspections, tax consulting and audit.
Website development, software adaptation, office IT support, recruitment and HR administration.
We develop and help implement a marketing strategy for distribution or the localisation of manufacturing in Russia.
We analyse tender terms, prepare documentation and provide legal support for participation in state and municipal procurement.
We help organise warranty, servicing and repair support for medical equipment in Russia.
An independent business and operational track
Representation outcome
On completion of the agreed scope of work, the foreign company has a manageable infrastructure for its presence in the Russian market, with screened partners, operational support and a plan for further development.
An agreed roadmap and a clear structure for the company’s operations in Russia.
A screened pool of potential counterparties and priority areas for cooperation.
Legal, financial, IT and HR processes within the agreed scope.
A strategy for distribution, procurement, localisation and servicing support.
The final deliverables depend on the selected scope of services and are specified in the contract.
Choosing a service
During the initial consultation, we determine whether one service area is sufficient or whether it is more effective to coordinate the regulatory and commercial tracks.
Choose registration services if your Russian infrastructure is already in place or will be arranged separately.
Registration →Choose representation if you need partners, operational infrastructure, sales, procurement or localisation.
Representation →We combine both services, coordinating the registration procedure and the development of commercial infrastructure in an agreed sequence.
Combined approach →Shared expertise
Whichever service you choose, we assign responsible specialists, monitor deadlines, maintain confidentiality and provide regular project updates.
We understand Russian legal requirements and support communication with all parties involved in the registration procedure.
We coordinate legal, financial, commercial, HR and technical tasks within a single project team.
We prepare a roadmap, define milestones, provide progress reports and remain in contact after launch.
We work only with accredited laboratories and vetted medical institutions. This helps us manage the quality of testing arrangements and coordinate all participants in the process.
Registration pathway
We determine the applicable procedure after assessing the device, manufacturer, risk class and readiness of the documentation.
Rules for state registration of medical devices, applied with regard to the project’s characteristics and the current version of the regulation.
Official text of the documentA special procedure for the circulation of medical devices; its applicability must be assessed for each project.
Official text of the documentSpecial provisions for the circulation and registration of a series or batch of medical devices in the specified circumstances.
Official text of the documentFrequently asked questions
Assessment of initial information, a roadmap, preparation of documentation, organisation of testing, support with QMS and the registration procedure, and post-registration tasks within the agreed scope.
They depend on the device’s intended purpose and risk class, document readiness, the need for testing and QMS assessment, and the selected procedure. Following the initial assessment, we prepare a roadmap and a commercial proposal.
Yes. We select accredited laboratories and medical institutions, coordinate documents and samples, and oversee the work and delivery of results.
The scope may include finding clients, screening counterparties, legal, accounting, tax, IT and HR support, procurement, localisation and servicing support.
We compile a list of potential partners and analyse available legal, financial and business information before contractual work begins.
Yes. We help analyse tenders and prepare documentation, and develop a strategy for distribution or manufacturing localisation.
No. Registration and representation can be commissioned independently. A combined approach is appropriate when you need both market authorisation for a device and the infrastructure to bring it to market.
We prepare a shared roadmap with separate regulatory and commercial stages, milestones and responsible specialists.
We can continue supporting amendments, monitoring and adverse events, as well as operational, procurement, warranty and servicing tasks.
