Wholesale Trade of Medical Devices in Bulgaria – Regulatory Support

Wholesale trade in medical devices on the territory of the Republic of Bulgaria is subject to a specific regulatory regime under the Medical Devices Act and is carried out with a permit issued by the Medicines Executive Agency.

Legatio Consult provides comprehensive regulatory and legal support to companies seeking to obtain a permit for wholesale trade in medical devices in Bulgaria. Our services are designed for Bulgarian and international businesses operating in the medical devices and life sciences sector that require a reliable, compliant and well-structured market entry.

We assist natural and legal persons established in Bulgaria, the European Union, the European Economic Area or Switzerland throughout the entire permitting process, ensuring full alignment with the applicable regulatory framework and the requirements of the Bulgarian authorities.

Our support covers the end-to-end management of the procedure, including regulatory guidance, preparation and coordination of the submission, communication with the competent authority, and ongoing assistance until the permit is successfully issued. We work closely with our clients to ensure that their operational setup, internal processes and compliance standards meet all legal and regulatory expectations.

In addition, we advise wholesale traders of medical devices on their post-authorisation obligations, including regulatory compliance, product safety requirements, change notifications, and ongoing market surveillance responsibilities. Our approach is preventive and strategic, aimed at minimising regulatory risk and ensuring long-term operational stability.

Legatio Consult combines regulatory expertise, legal precision and practical industry insight, offering a trusted advisory service for companies entering or expanding within the Bulgarian medical devices market.

How We Can Assist

Legatio Consult is a legal and accounting advisory firm specialising in regulatory, corporate and compliance support for international and domestic companies in regulated industries.