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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