Registration of medical devices in the EAEU
13 years of successful work and presence in 12 CIS and EAEU countries
Registration and re-registration of medical devices and
medical equipment
Registration and re-registration of medical devices and
medical equipment
The registration and re-registration process usually includes the following steps:
- Preparation of the necessary documentation in accordance with the requirements of the EAEU legislation. Documentation preparation includes the preparation of all necessary documents, such as registration applications, technical documentation, clinical trial results and other required materials.
- Submitting an application for registration or re-registration of a product to the appropriate regulatory authority. The prepared documentation is submitted to the appropriate regulatory authority in the EAEU country where registration is required. Typically this may be from the Ministry of Health or the regulatory authority.
- Conducting an examination of submitted documents and carrying out the necessary tests. The regulatory authority reviews the submitted documents and may require additional testing or clinical studies to confirm the safety and effectiveness of the product.
- Obtaining a certificate of registration or re-registration of a product. Upon completion of consideration of the application, the regulatory agency makes a decision on registration or re-registration of the product. If the application is approved, it issues a registration certificate, which confirms the right to release and sell the product on the EAEU market.
Stages of registration of medical devices and
medical equipment
Stages of registration of medical devices and
medical equipment
1
Preparation of dossier and receipt of drug samples and standard samples from the customer
2
Submitting an application for payment and an application to the regulatory authority
3
Submission and uploading of the registration dossier to the examination portal of the NC
4
Submission of drug samples and standard samples
5
Expertise (initial and specialized)
6
Laboratory tests (analytical)
7
Safety Conclusion
8
Submitting an application for an order and obtaining a registration certificate, approved documents from the regulatory authority
9
Obtaining a registration certificate, approved documents from the regulatory authority
Our specialists will bring any project to the end, they will always tell you what strategy to choose and how to prepare the documents correctly!
Registration and re-registration of medicinal products and
medical products
medical products
Advantages of services for registration of drugs and medical devices
-
Registration of a medicinal product "on a turnkey basis", from drawing up a registration dossier to obtaining a registration certificate.
1 - Interact with regulatory authorities and complete all stages of registration, including responding to requests and correcting deficiencies.2
- Drawing up and execution of the necessary documents for filing an application, including test reports, drug dossier, instructions for use and other documents.3
- Preparing and presenting electronic and paper documentation based on specifications and methods.4
- Maintenance and support after successful registration, including monitoring compliance with requirements, periodic re-registration and changes to registration documents.5
- Consultations and assistance in developing a registration strategy, risk analysis and assessment of required documents.6
We employ specialists of the highest class who will help implement your projects!
Advantages of registering medical devices:
Quality
Our reputation is of great importance to us, and we are always focused on the successful completion of every project.
Support
Each member of our team has at least 5 years of experience in the pharmaceutical field.
Multidisciplinary
Our company is engaged in various fields of activity, in each of which we have achieved an outstanding professional level.
Experience
Over the course of 15 years, we have accumulated valuable experience in the field of registration and certification, we are aware of all the intricacies and take into account all the important aspects of this process.
Discount
We offer a 10% discount on initial registration.
Individual approach
We take into account the individual characteristics of each client to provide the best service and approach.
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Our services:
A full range of services to support the process of registration, re-registration, and changes to the registration dossier for medicines.
Comprehensive support for the process of registration, re-registration and updating of the registration dossier for medical devices and medical equipment in the Eurasian Economic Union (EAEU).
Providing comprehensive marketing services and representing the interests of the manufacturer at the regional level.
Providing a wide range of services for marketing authorization holders and pharmaceutical factories in the field of pharmacovigilance and product quality control.
Professional assistance in setting wholesale and retail prices for medicines and medical products within the framework of the guaranteed volume of free medical care.
A set of measures aimed at confirming the quality and safety of products.
Would you like to know the price for registration of medical devices?
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Our presence in other countries
We represent the interests of foreign companies in Kazakhstan, Belarus, Kyrgyzstan, Azerbaijan, Georgia, Armenia, Uzbekistan, Tajikistan, Mongolia and Turkmenistan, in other countries of the EAEU and the CIS.
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Contacts
050057, Republic of Kazakhstan,
Almaty, Timiryazev St., 42k23; office 202
Almaty, Timiryazev St., 42k23; office 202
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+7 (727) 269 54 59