Regulations
The Eurasian Economic Union (EAEU) includes Armenia medical device registration pathways, Uzbekistan medical device registration protocols, and the markets of Kazakhstan, Kyrgyzstan, and the Russian Federation. We facilitate medical device registrations throughout the union, providing expert guidance on the following activities.The rules for registering products are different in each place. This includes when you have to register and how much it costs. The certificates that prove something is registered are also good for amounts of time. In the year 2026 medical device companies need to make sure they meet the EAEU medical device registration standards. This is very important for all medical device companies. To keep selling their products in these markets medical device companies must get their technical dossiers ready, before the deadlines that the government sets for medical device registration. Adherence to EAEU integration protocols is required for medical device distribution in Central Asia. Morulaa Health Tech is recognized as a primary Asia medical device consultant, bridging the gap between global manufacturers and regional regulators.
The Kazakhstan medical device registration is a mandatory regulatory requirement governed by the National Center for Expertise of Medicines and Medical Devices (NDDA). Under the 2026 regulatory framework, the national registration pathway remains an active alternative to the unified Kazakhstan medical device registration procedure until the deadline of December 31, 2027.
The financial structure for Kazakhstan consists of a two-tiered system. The technical evaluation process includes an administrative review followed by a specialized technical examination to verify safety, quality, and clinical efficacy. A legal requirement for this market is the appointment of a local authorized representative to manage post-market surveillance duties. As an Asia medical device consultant, we ensure language regulations are met, mandating that all product labeling and instructions for use be provided in both Kazakh and Russian.
The standard timeline is between 70 and 110 working days. Certificates issued under the national pathway carry permanent validity, though many firms are now opting for the Kazakhstan medical device registration to cover multiple countries at once.
The Uzbekistan medical device registration is something that the government rules that is taken care of by the Center for Pharmaceutical Products Safety. This center is part of the Ministry of Health, in Uzbekistan. They make sure that all medical devices are safe to use. The Uzbekistan medical device registration is a part of this process. Following Resolution No. 738, all medical equipment must go through state registration before being legally sold. Foreign manufacturers must appoint a local authorized representative to coordinate the submission of a registration dossier containing technical files and ISO 13485 certification.
This system uses a Class I, II, and III classification system. While the standard Uzbekistan medical device registration procedure duration is 155 working days, a recognition pathway exists for devices approved by the FDA or EMA. Approved devices receive a certificate valid for 5 years. This framework ensures that all healthcare technology follows the standardization and quality control protocols established by the State Center.
The State Department of Medicine Provision and Medical Equipment executes Kyrgyzstan Medical Device Registration. The regulatory environment is currently affected by Kyrgyzstan’s status within the EAEU. A transition to a combined EAEU medical device registration regulatory framework is in progress.
The kyrgyzstan republic has maintained its national registration procedure through a formal extension period, but the unified EAEU medical device registration enforcement began on January 1, 2026. This shift requires compliance with standardized EAEU protocols for all medical equipment. Technical documentation must reflect these specific date parameters to ensure legal market access and avoid administrative rejection. Navigating these changes requires an experienced Asia medical device consultant to ensure that classification and clinical evidence align with the new union-wide regulations.
For Armenia medical device registration, manufacturers must follow the requirements of the Scientific Centre of Drug and Medical Technology Expertise (SCDMTE). Per EAEU Decision No. 46, the Armenia medical device registration process involves an accurate evaluation of safety and effectiveness.
When the SCDMTE finishes checking and a registration certificate is given the device is allowed to be sold. People who bring these devices into the country still need to do extra checks to make sure they keep following the rules for medical devices in the country and in the EAEU. It is very important to pick the way to register medical devices in Asia because Armenia is a big doorway to the rest of the Eurasian market. The right Asia medical device registration strategy will help with this. Armenia is a point to get into the Eurasian market and the right strategy for Asia medical device registration is necessary.
At Morulaa Health Tech, we treat your EAEU medical device registration as a global project. We ensure every submission meets the foundational requirements of Asia medical device registration:
Classification: Precise device classification according to EAEU medical device registration law.
Documentation: We facilitate Consularized Free Sale Certificates (FSC) and Declarations of Conformity.
QMS: Ensuring ISO 13485 or MDSAP certification is valid for Asia medical device registration.
Localization: Localization of IFUs and labelling into native languages for Uzbekistan medical device registration and Armenia medical device registration.
Technical Support: Technical File and Clinical Evaluation (CER) compilation as part of our Asia medical device registration service.
In Asia medical device registration through a single Asia medical device consultant, you ensure that your EAEU medical device registration is handled with consistency across all member states. Whether you are focusing on a single Uzbekistan medical device registration, our expertise minimizes delays and maximizes market authority.
Do Free Sale Certificates require special legalization for this region?
Yes. In Central Asia, simple copies are usually rejected. As your Asia medical device consultant, we coordinate the formal confirmation of your FSC to ensure it is legally recognised.
Does MDSAP certification waive the need for EAEU audits?
Not necessarily. While MDSAP is vital for your EAEU medical device registration dossier, regional authorities may still mandate a targeted QMS audit for high-risk devices.
What is the benefit of the EAEU "Reference State" model for EAEU medical device registration?
This model allows you to gain primary approval in one "Reference State" (like Kazakhstan) and then seek mutual recognition in other member states. This "one-dossier" approach is the most efficient way to manage EAEU medical device registration, and our team handles the entire multi-state coordination as your asia medical device consultant.
What happens to my national registrations when the EAEU transition deadline arrives?
The EAEU has a deadline. This is important for my EAEU medical device registrations. As I understand it all EAEU medical devices have to be registered with the medical device registration system by the end of 2026. My national certificates for medical devices that I got before the EAEU rules were fully in place will not be valid forever. So it is very important for me to start working with an Asia medical device consultant, for medical devices now so they can help me with the process of converting my EAEU medical device registrations.
Central Asia Medical Device Consultant
Kazakhstan Medical Device Registration
Uzbekistan Medical Device Registration