Registration of medical devices in RF and EAEU

We will take over the entire process of registering a medical device and help you get a registration certificate within 6 to 12 months
Deep knowledge of legislation.
Regulatory requirements are constantly changing. We keep our finger on the pulse of all updates and prepare documents in advance that comply with current standards. This saves you from revisions and speeds up the approval stages.
About us
Comprehensive project support.
From the initial consultation to obtaining a registration certificate, you receive full support at every stage. We take care of all issues so that you can focus on business development.
Effective interaction with certification authorities.
We work directly with experts from regulatory authorities and know how to optimize communication. This allows us to minimize the time spent on checking applications.
Documentation audit before submission.
Did you know that more than 50% of refusals are due to incorrect documentation? We analyze your documentation, identify weaknesses and give clear recommendations on how to correct them.
Our team at "Profmedreg" knows how to avoid the hassle of registering medical devices and make the process easier, more transparent and faster. We work with manufacturers and sellers of medical devices all over the country and help to bring their products to the market in the shortest possible time.

Thanks to our experience and well-established processes:
— 70% of customers register products from the first submission of documents.
— Preparation times are reduced by up to 30%.

You save not only time, but also nerves. We have already helped dozens of companies successfully register and bring their medical products to market. Now our task is to help you!

Get a free consultation on the registration and handling of medical devices
We appreciate your time, so we are ready to promptly answer any questions! Leave your phone number and our chief specialist will contact you in the next 15 minutes!
During the meeting, we will:
🔍 Evaluate your documentation and point out key points for revision.
📋 Develop an individual registration strategy.
📈 Share real cases on how to reduce timeframes and avoid mistakes.
Additional services
Certification of services, laboratory tests:
– Forming Conformity Declarations on medical articles
– Certificate of Conformity of the Customs Union (TR CU)
– Declaration of Conformity of the Customs Union (TR CU)
– Certificate of Conformity GOST R
– Voluntary certification GOST R
– Certificate of Conformity TR RF
– Declaration of Conformity TR RF
– Certification in the system of European Directives
– Certificate of Origin (form ST-1)
Certification of services, laboratory tests:
– Forming Conformity Declarations on medical articles
– Certificate of Conformity of the Customs Union (TR CU)
– Declaration of Conformity of the Customs Union (TR CU)
– Certificate of Conformity GOST R
– Voluntary certification GOST R
– Certificate of Conformity TR RF
– Declaration of Conformity TR RF
– Certification in the system of European Directives
– Certificate of Origin (form ST-1)
– Audit, expert opinions and registration of technical documentation
– Product passport
– Production Control Program (PPK)
– Implementation of production control program (PPK)
– Enterprise and Organization Standard (STP/SRT)
– Operating Manual (RE)
– Safety Data Sheet (PB)
– Safety data Sheet of chemical products (MSDS, RF)
– Safety justification (OB)
– Technological Instruction (TI)
– Technical specifications (TU)
– Technical and Technological maps (TTK)
– Audit, expert opinions and registration of technical documentation
– Product passport
– Production Control Program (PPK)
– Implementation of production control program (PPK)
– Enterprise and Organization Standard (STP/SRT)
– Operating Manual (RE)
– Safety Data Sheet (PB)
– Safety data Sheet of chemical products (MSDS, RF)
– Safety justification (OB)
– Technological Instruction (TI)
– Technical specifications (TU)
– Technical and Technological maps (TTK)
— Barcoding
— License of the Ministry of Culture
— Entry into the register of the Ministry of Industry and Trade
— Entry into the National Register of Reliable Suppliers and Services
— Trademark registration
— Trademark registration
— Patenting
— Industrial safety expertise
— Industrial Safety certification
— Joining the SRO (design and construction)
— Development of documentation for registration of a medical device
— ISO certificate
— CMK (quality management system)
— VIRU (making changes to the registration certificate)
— Audit of documentation
— Request to Roszdravnadzor
— Receipt of a duplicate of the RU
— Approval and extension of the validity period of the TU
— Selection of the type of nomenclature classifier
— Search/support in laboratories (free of charge)
— Services for obtaining an explanatory letter (refusal letter)
— Barcoding
— License of the Ministry of Culture
— Entry into the register of the Ministry of Industry and Trade
— Entry into the National Register of Reliable Suppliers and Services
— Trademark registration
— Trademark registration
— Patenting
— Industrial safety expertise
— Industrial Safety certification
— Joining the SRO (design and construction)
— Development of documentation for registration of a medical device
— ISO certificate
— CMK (quality management system)
— VIRU (making changes to the registration certificate)
— Audit of documentation
— Request to Roszdravnadzor
— Receipt of a duplicate of the RU
— Approval and extension of the validity period of the TU
— Selection of the type of nomenclature classifier
— Search/support in laboratories (free of charge)
— Services for obtaining an explanatory letter (refusal letter)
Moscow, 8/2 Myasnitskaya str.
We work mon-fri from 9:00-20:00 (Moscow time)
RU | EN
Sole proprietor Khalapyan Nelli Olegovna
TIN 235401964510
OGRN 324508100476474
© 2023 All rights reserved
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