At Med Comply Global, we provide professional Authorized Representative (AR) services to ensure your medical devices and medicinal products meet the legal and regulatory requirements in Uzbekistan, Kazakhstan, Kyrgyzstan, Azerbaijan, Georgia, Armenia, Russia, and Ukraine. Acting as your official liaison with national regulatory authorities, we help navigate local requirements for compliance, enabling smooth market entry and operations.

What We Offer

• Regulatory Representation: We act as your legal entity within the country to fulfill local regulations.
• Document Submission and Communication: We manage submissions, communications, and follow-ups with regulatory authorities on your behalf.
• Ongoing Compliance: We ensure your products remain compliant throughout their lifecycle by monitoring regulatory changes and updating your documentation.
• Local Expertise: Our team in each country is well-versed in national legislation and has established relationships with competent authorities to facilitate efficient processes.

Country-Specific Authorized Representative Services

Uzbekistan

In Uzbekistan, regulatory requirements demand a local representative to act as a liaison with the Ministry of Health. We ensure:

• Timely submission of registration and renewal documents.
• Compliance with Uzbekistan’s specific labeling and safety regulations.
• Proactive monitoring of regulatory changes to maintain compliance.

Kazakhstan

Kazakhstan’s medical device market requires an Authorized Representative to handle:

• Registration and certification through local regulatory bodies.
• GMP conformity checks and product dossier submissions.
• On-ground support for regulatory inspections and audits.

Kyrgyzstan

In Kyrgyzstan, our AR services include:

• Representation with the Department of Medicines and Medical Equipment.
• Submission of documentation in the required formats, ensuring compliance with local standards.
• Addressing variations and renewals promptly for uninterrupted market access.

Azerbaijan

In Azerbaijan, our team handles:

• Regulatory submissions in the national or CTD format.
• Communication with the Ministry of Health and local authorities.
• Ensuring compliance with pharmacovigilance and labeling requirements.

Georgia

Georgia’s regulatory framework is evolving, and we ensure:

• Effective communication with the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health, and Social Affairs.
• Adherence to requirements for product registration and labeling.
• Ongoing monitoring of safety data for compliance.

Armenia

As a member of the Eurasian Economic Union (EAEU), Armenia requires:

• Unified or national procedure compliance for product registration.
• Pharmacovigilance systems set up and maintained for medical devices and drugs.
• Local representation for regulatory inspections and follow-ups.

Russia

Russia has stringent requirements, and our services cover:

• Comprehensive dossier preparation and submission to Roszdravnadzor.
• Assistance in local clinical trials and product testing when required.
• Representation for ongoing compliance and variation approvals.

Ukraine

Ukraine’s advanced regulatory landscape requires expertise, and we provide:

• Representation with the State Service of Ukraine on Medicines and Drugs Control.
• Submission of dossiers aligned with PIC/S and European standards.
• Regular updates on regulatory changes affecting your products.

Why Choose Med Comply Global as Your Authorized Representative?

• Local Presence: Dedicated teams in each country provide unmatched regulatory support.
• Proven Expertise: Years of experience ensure efficient navigation of complex legal frameworks.
• End-to-End Service: From initial representation to ongoing compliance, we manage it all.

By choosing Med Comply Global as your Authorized Representative, you can confidently expand your operations into Uzbekistan, Kazakhstan, Kyrgyzstan, Azerbaijan, Georgia, Armenia, Russia, and Ukraine, knowing your compliance needs are in expert hands.