Local EAEU Medical Device & IVD Experts.
To pave the way to your registration certificate.
Biomapas’ local experts can provide you with regulatory Medical Device Services in the EAEU to pave the way to your registration certificate. The Eurasian Economic Union’s medical device registration system is still adjusting and updating its recommendations: the details and small regulations are continuously changing as there are some discrepancies and gaps that can cause future issues. However, as the new system entered into force in 2022, the essential must-know points for medical device legislation in the EAEU remain the same: what is the EAEU medical device legislation structure? What are the new regulations and approaches? What are the differences between EAEU and EU medical device regulations? What is the transition period, and what happens after it expires?
We have local experts who can answer these questions and support you at every stage of the Medical Device or In Vitro Diagnostics lifecycle. Also, we can help you to include all the variants of the Medical device and accessories in the registration dossier and successfully obtain a registration certificate in EAEU and CIS regions.
Take your Medical Device or IVD from development to approval.
A seamless extension to your team that enables you to enter the EAEU & CIS markets.
Regulatory Medical Device Services in the EAEU:
- Guidance on medical device classification in EAEU and CIS;
- Technical File Preparation for Medical Devices and IVDs;
- Interaction with and documentation preparation for Competent Authorities;
- Support with Technical testing and biological (toxicology) studies in EAEU;
- Authorized Representative service in EAEU;
- Clinical evaluation support in EAEU;
- Pattern approval certificate services for medical devices with measurement functions.
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Jan 6, 2022
Webinar: Smooth Switch to the EAEU Marketing Authorization for Medicinal Products The webinar will highlight the practical tips and guide you through the crucial steps of marketing authorization upgrade to the Eurasian Economic Union (EAEU) one, ultimately leading you...
Dec 20, 2021
There is an increased demand for Materiovigilance solutions in recent years as the usage of medical devices keeps growing. Current industry changes are already impacting future developments, and it is becoming more and more challenging to keep up with recent...
Jul 9, 2021
Since the establishment of the Eurasian Economic Union in 2015, a significant change is quickly coming into life: a new regional registration system for medical devices is coming into effect from the start of 2022. As most registrations are completed through national...