Regulations
Last Updated: 07 August 2026
Expanding your healthcare technology footprint through asia medical device registration in Central Asia and the larger Eurasian Economic Union (EAEU) requires an exceptionally targeted approach. Manufacturers should be aware of the significant language requirements, as well as very specific vigilance timelines. When expanding medical device sales to Central Asia, you risk spending too much time and effort dealing with multiple ministries of health, which is why having a central regulatory partner is often the most sensible choice. Morulaa Health Tech can act as your regulatory partner by preparing technical dossiers, managing local representation, and overseeing product lifecycle management in Kazakhstan, Uzbekistan, Kyrgyzstan, Armenia, and other Central Asian states. We have the competencies and experience to provide you with technical documentation services, as well as timeline assistance throughout the registration process, which will be tailored to the legal requirements of the particular state. We can manage your Central Asia medical device registrations and help you navigate the local regulatory environment with ease and confidence.
Asia medical device registration: Kazakhstan Entry Pathway For Kazakhstan Medical Device Registration
Medical devices in Kazakhstan are under the jurisdiction of National Center for Expertise of Medicines and Medical Devices (NDDA) and the Eurasian Economic Union (EAEU) which fall under the Ministry of Health. Before completing a Kazakhstan medical device registration, devices must be submitted for approval. The transitional period under EAEU has been extended until December 31, 2027, meaning that medical device manufacturers may continue to use the national procedure for Kazakhstan medical device registration. This alternative option offers a number of advantages including the possibility to apply existing clinical research data instead of performing expensive and time consuming local trials and the opportunity to obtain a registration certificate that is valid indefinitely. Morulaa is here to assist in preparing your technical and risk management dossiers in NDDA (NCEMMD) format, and securing a registration procedure that meets the requirements of the Kazakhstan National Regulations or EAEU medical device registration standards.
Below are the most important points to consider when applying for a kazakhstan medical device registration:
Documentation: Ensuring that you meet the requirements for notarized Russian and Kazakh versions of the documents.
Timelines: 4 months for Class I devices; 5 to 10 months for Class II a, II b and III devices.
Government fees: ~$1,500 to $2,500 for Class I; ~$7,000 to $12,000+ for Class III.
Vigilance: Report incidents that may involve serious public health concerns and deaths or serious injuries within 15 days; report other incidents within 30 days.
Uzbekistan medical device registration Rules
As of Feb 26, 2026, Uzbekistan medical device registration will follow a new procedure established by the resolution No. 738. The new regulation is managed by the Uzpharm control (State Center for Expertise and Standardization). The updated system requires a more detailed risk based Classification which allows Uzbekistan to stay compliant with international standards, while being independent from the EAEU unified procedure. Under the new rules, Uzbekistan medical device registration for high risk medical devices now requires verification of positive clinical trial results and more stringent intellectual property checks.
The following steps are required for Uzbekistan medical device registration:
Documentation & representation: A local representative is mandatory, your submission must include Russian instructions and documents, a power of attorney, and a certificate of registration of the device in your country of origin
Timelines: It will take 6-9 months for Class I, 8-10 months for Class IIa/IIb, and up to 1 year for Class III devices to register
Government fees: They will depend on the risk level, with the lowest being $1,500 to $2,500 for Class I and highest being $5,500 to $8,000+
Vigilance: Report serious incidents threatening public health within 15 days and other incidents within 30 days.
Kyrgyzstan Medical Device Registration
Kyrgyzstan medical device registration is controlled by the Department of Medicinal Products and Medical Devices (DMMD) in the Ministry of Health. Being part of the Eurasian Economic Union (EAEU), the country is now entering the transitional period: previously, the date of EAEU application was set as December 31, 2025 – thus, until this date, medical device manufacturers could apply under the national procedure. However, it has been changed to December 31, 2027, meaning that companies have more time to adapt to the new situation. Registration of medical devices in Kyrgyzstan under the national procedure now allows medical device manufacturers to make the process of placing their products on the market as seamless as possible while they prepare themselves for the transition to the EAEU procedure. Morulaa can assist you in this process by preparing your technical documentation and clinical data in the format required by the Kyrgyzstan FDA equivalent – DMMD. This way, you will meet all the requirements and streamline asia medical device registration across the region.
Below are the most important points to consider when applying for a medical device registration in Kyrgyzstan:
Documentation & Representation: A local representative should be appointed for foreign manufacturers. A Free Sale Certificate and state registration dossiers translated into Russian are required.
Timelines: Compared to many other jurisdictions, Kyrgyzstan is a really fast option for medical device registration: 2-4 weeks for Class I, 1-2 months for Class IIa/IIb, and 2-3 months for Class III devices.
Government Fees: The state fees are the same for all the device Classes, amounting to 3,000 – 5,000 KGS.
Vigilance: 15 days – for serious incidents/death and 30 days for other incidents.
Armenia Medical Device Registration
Armenia medical device registration has changed the primary registration process into the system of the Eurasian Economic Union. Though EAEU registration process is the default one for new devices, the Armenian authorities allowed using the national registration process occasionally in order to ensure Armenia medical device registration market stability. The producers should prove the quality of the products providing the technical documentation to the Ministry of Health. Despite the fact that the national approvals issued before 2022 are valid until their expiry date, any new product should meet the EAEU requirements. From January 1, 2022, new armenia medical device registration applications should be conducted according to the unified system of the EAEU, because the national one is not available anymore.
Below are key requirements for Armenia medical device registration:
Documentation & Representation: A local representative is mandatory. The registration dossier, technical documentation, and Free Sale Certificate must be provided in Russian or Armenian languages.
Timelines: The most efficient way is to choose a 1-2 week timeline for Class I, 2-4 week timeline for Class IIa/IIb, and 3-5 month timeline for Class III.
Government Fees: The cost for all the Classes is 40,000 AMD.
Vigilance: The standard vigilance timeline is 15 days for threats/interventions and 30 days for non serious incidents.
Asia Medical Device Registration: Frameworks, Transition & How Morulaa Can Help
Morulaa Health Tech in Central Asia and the EAEU can assist in ensuring your submission is in accordance with the key regulations in the region. We work as your consultant to ensure your compliance with these important regulations. so that you can focus on commercialization. Get a quote now to register your device in Central Asia and EAEU regions.
FAQS
Is any special legalization required for a Free Sale Certificate in this region?
Yes. Simple copies will not be accepted in Central Asia. Your asia medical device registration consultant will take care of legal confirmation of your FSC to ensure its validity.
Does MDSAP certification mean that there is no need for EAEU audits?
It depends on the situation. Although MDSAP certification is important for your medical device registration in the EAEU region, the regulatory authorities might demand a separate QMS audit for high risk devices.
What are the benefits of the EAEU "Reference State" model for EAEU medical device registration?
According to this model, it is possible to receive primary approval in the "Reference State" (for example, in a Kazakhstan medical device registration), and afterwards, apply for mutual recognition in other member countries. It is the most effective way to manage your EAEU medical device registration, and we take care of the entire multi state procedure as your regulatory partner.
What happens with my national registrations after the deadline for transition to EAEU?
The EAEU transition deadline is an essential issue for EAEU medical device regulation. We believe that all medical devices in the EAEU should be registered in the medical device registration system by the end of 2026. National certificates for medical devices, which were issued before EAEU medical device regulations came into force, will not be valid after a while. Therefore, it is critical to find an asia medical device registration consultant for medical device manufacturers to help in converting to EAEU medical device registration.
What are the requirements for Central Asian medical device registration?
Registration in Central Asia varies by country and requires a local authorized representative and a technical dossier in the local language or Russian. While countries such as Armenia and Kazakhstan have switched to EAEU standards, Uzbekistan medical device registration follows an independent national registration system with certain requirements regarding clinical trials and tests.