EAEU Regulatory Compliance – Overview
The Eurasian Economic Union (EAEU) member countries include Armenia, Belarus, Kazakhstan, Kyrgyzstan, and the Russian Federation. The union represents a significant market with a combined population of 183 million people and an economic power of 1.8 trillion Euros.
The EAEU has its own Regulatory framework for medicinal products and medical devices, which includes harmonized guidelines for the approval of medicinal products. There are ongoing discussions and initiatives, such as the Lisbon-Vladivostok initiative, aimed at fostering economic cooperation between the EU and the EAEU, particularly in the field of medicinal products and medical devices, including EAEU medical device registration. This includes the potential for mutual recognition of clinical trials, harmonization of authorization procedures, and alignment of Good Manufacturing Practice (GMP) inspections.
EAEU Regulatory Compliance
We provide services and support for the EAEU medical device registrations for countries like Russia, Kazakhstan, Armenia, Belarus, and Kyrgyzstan. Our consultant supported activities for the EAEU medical device registrations includes:
- Devices & In Vitro Diagnostic (IVD) Devices Registration Support.
- Local Representative (LR) Support.
- Regulatory Intelligence.
- Gap Assessment of Documents.
- Lab and Clinical Testing Services for Devices.
- Technical Documentation Writing.
- Instructions for Use (IFU) Preparation.
- Translation Support.
- Medical Writing Support for CER and PER.
- Pharmacovigilance (PV) Services.
- Labeling and artwork Services.
- QMS/Audit Services.
