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More about requirements, market review and general information about Russian market
When is it impossible to avoid conducting clinical trials with human subject on the territory of the Russian Federation?…
On 1 January 2017, the federal Law on Biomedical Cell Products (BMCP) came into force, regulating relations arising at all…
In accordance with Order N 885n, clinical trials of medical devices for in vitro diagnostics are conducted in laboratory…
All perfume and cosmetic product in consumer package falls under Custom Union Technical Regulation for cosmetics – CU TR…
Pharmaceuticals for human use registration
The main criterion for the possibility of conducting trials in the form of clinical evaluation is the presence of an interchangeable…
In addition to medical devices, biomedical cell products and medicines, many biologically active additives enter Russian…
Operational documentation for medical products
The healthcare expenses in Kazakhstan are equal to 3,7% of the GDP, which is lower than average in countries with the same…
In terms of money, the socially-economical performance of the Armenian healthcare system is one of the lowest.
Kyrgyzstan has launched a massive reform of its healthcare system and first of all, it is aimed at increasing first aid availability.
Manufacturers of medical devices should implement a risk management process throughout the life cycle of the medical device.
Technical Dossier for local manufacturers
Uzbekistan is a country with one of the most rapidly growing populations all over the CIS region.
Technical file
Healthcare expenses in Belarus are gradually rising: compared to the previous year, in 2022 they increased by 10% in terms…
The procedure for receiving a duplicate of the registration certificate (RC) is regulated by paragraph 52 of the Decree of…
Amendment to registration certificate in EAEU
Amendment to registration certificate in Russia
Post-registration monitoring of medical devices (monitoring) consists of two main parts
The rules for monitoring the safety, quality and effectiveness of medical devices are established by the Decision of the…
Amendment to technical dossier in Russia
Authorized Representative services for medical devices and IVD
The rules for registering medical devices
Your journey to successful registration of medical devices in the Eurasian Economic Union (EAEU) starts here!
Registration of medical devices within the Eurasian Economic Union
Medical device registration under national rules in Russia, initial registration for all types of medical products and IVDs
The registration certificate of Roszdravnadzor is an approval document required for the circulation and use of a medical…
Approvals for medical devices under EAEU regulatory scheme: one certificate for five countries
Clinical trials for medical devices and IVD: as clinical evaluation or with human subject, inside Russia
Regulatory ways if manufacturer already have registration certificate in Russia and want to be up-to-date with regulation
Market access for IVD products within the general registration scheme for local Russian regulation mirrors that of medical…
Apart from the general registration scheme within the Russian medical device market, there are several fast-track regulatory…
Classification marks the initial phase of the registration process. The pricing and timeline of registration projects depend…
Medical device national registration in Russian area countries (Uzbekistan, Kazakhstan, et)
Local representative for Russian regulation and EAEU regulation as third-party services. Government control for medical device…
Approvals for not medical devices: pharmaceuticals, dietary supplements, cosmetics and biomedical cell products
Registration process is based on responsibility of manufacturer of medical device and Ministry of Health work (department-…
CU TR 020/2011 - EMC
Within the framework of product compliance assessment, there must be a person responsible for ensuring such compliance or…
552 - Decree of the Government of the Russian Federation 552 (accelerated registration of medical devices
Expedited Registration - Regulation 299
Government Decree 430 - abbreviated diagram