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Registration and launch of medical products

We bring medical brands to the markets of Russia and the EAEU on a turnkey basis

hero
gal

100+

of medical brands was successfully
launched on the Russian market

Services

Areas of activity

about

Support for registration of medical products — from the formation of the registration dossier to obtaining the registration certificate.

Term: from 6 months.

about

Support for making changes to the medical product registration dossier — from organizing
tests and studies to obtaining an updated registration certificate.

Term: from 1 month.

about

Development of technical and operational documentation for a medical product (technical specifications, extract from the technical file, operational documentation, etc.).

Refinement of additional registration dossier documents:

  • Risk management file for the product
  • Usability file
  • Information on regulatory documentation
  • протоколы квалификационных испытаний (заводские)
  • Qualification test protocols (factory tests)
  • Quality management system (QMS) document package, including the quality manual for production inspection
  • Sterilization process validation report
  • Packaging process validation report
  • Sterilization process validation protocol
  • Packaging process validation protocol
  • Safety data sheets for raw materials and packaging, etc.

Term: from 1 month.

about

Organization of technical, toxicological, and clinical trials, interaction with testing centers and laboratories, adjustment of dossier documents, preparation of the program, protocol, and evaluation report based on the test results.

Term: from 2 months.

about

Production inspection is an assessment of manufacturing compliance with the requirements for the implementation, maintenance, and evaluation of a product quality management system, depending on the potential risk of its application.

Production inspection is mandatory for medical devices of classes 2a (sterile), 2b, and 3.
Inspections apply to both domestic and foreign manufacturers.

An inspection report is required for the state registration of medical devices and for making changes to the registration dossier.

The inspection is conducted by Roszdravnadzor and its subordinate institutions.

We provide support for initial, scheduled (periodic), and unscheduled inspections.

Term: from 2 months.

about

Clinical safety monitoring, promotion, distribution, and more — obtaining permission for sample import, post-registration monitoring, corrective action programs, support during regulatory inspections, market potential assessment and feasibility of product launch, development of a product promotion concept and market entry support, information campaign for a new product, business strategy development, and distribution.

Term: from 3 months.

about

Objects of Promotion

  • Pharmaceuticals
  • Medical technologies
  • Biologically active supplements
  • Medical devices

Advantages

Qualified support at every stage

We guide the client from the application submission to obtaining the registration certificate.

Process organization is our responsibility.

service

We implement a medical device quality management system.

You will receive complete documentation ready for use.

service

In case of Roszdravnadzor’s refusal, we provide support in appealing the decision.

We apply all available legal mechanisms to achieve the result.

service

About Us

LLC Faculty of Medical Law

is one of the oldest law firms specializing in the implementation of healthcare projects

100+

successfully introduced medical brands to the Russian market

20+

years of experience in the registration of medical devices

50+

our team: lawyers, economists, doctors, marketers, sociologists, and others

100+

legal support for tasks of any complexity in the field of medical device regulation

cta

We open the Russian market
for medical brands

Comprehensive support for the market entry of medical products in Russia

01

Market and regulatory research

02

Protection of exclusive rights and patenting

03

Production inspection

04

Registration

05

Launch

06

Promotion and Distribution

07

Safety monitoring

08

Regulatory compliance and oversight

Reviews

Customer Reviews

pharmaceutical companies, medical device manufacturers, distributors, healthcare organizations, and other companies implementing healthcare projects

We completed the registration of the medical device faster than expected — the full cycle of support really paid off!

The tests were carried out without delays, and competent support eliminated the risk of registration refusal!

We promptly made changes to the dossier and eliminated bureaucratic complexities — let’s keep moving forward!

FAQ

Frequently Asked Questions

Here you will find answers to the most popular questions. If you didn’t find the information you need, feel free to contact us!

The registration time depends on many factors, including the client’s readiness to submit the documents. On average, the process takes from 6 months to 1 year. If testing and research are required, the timeframe may be extended.

Yes, we provide services for supporting the changes to the registration dossier.

EAEU registration requirements differ from those of other countries. Additionally, research, testing, and inspection results must be provided. Beyond translating the documentation, it will likely need to be adapted to comply with local legal requirements. Our lawyers will assess the content and inform you of any additional information that needs to be provided.

Contacts

location

Address

13 Alabyana St., Bldg.1, Moscow

Reach us for questions

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