Medical Device Licensing

Medical Device Registration and Licensing in Georgia

Registration and market authorization of medical devices in Georgia are subject to strict regulation. In accordance with the "Law on Medicines and Pharmaceutical Activities" and government decrees, any item intended for medical use — from simple bandages to complex diagnostic equipment (MRI, CT) — requires compliance with quality and safety standards. From 2025, state registration of medical devices has become mandatory, which implies a detailed check of documentation, submission of CE marking or other recognized certificates, and labeling in the Georgian language. Import and sale of medical devices without registration is prohibited and leads to substantial fines, as well as product confiscation. Lawyer assistance is essential to navigate the complex registration procedure and effectively communicate with the regulatory body (Ministry of Health).

What Does This Service Cover?

Specialists on Legal.ge offer full legal support during the medical device registration process:

• Classification: Determining the class of the medical device (I, IIa, IIb, III), which defines the complexity of the registration procedure and required documentation.
• Documentation Audit: Checking the manufacturer's Technical File, ISO certificates, and Declaration of Conformity against Georgian legislation.
• Recognition Regime: Managing the simplified registration procedure if the product is already registered in the EU or USA.
• National Registration: Preparing and submitting the full registration dossier to the Agency for Regulation of Medical and Pharmaceutical Activities.
• Labeling and Instructions: Legal expertise of the text for the label and instructions for use in the Georgian language.
• Import Permit: Obtaining necessary permits for customs procedures.

Common Situations When You Need a Lawyer

In the medical device business, lawyer involvement is critical:

• New Product Launch: You want to import innovative medical equipment and don't know which regulations apply.
• Customs Delay: Cargo was held at customs due to lack of registration or incorrect HS Code.
• Registration Refusal: The Agency refused registration due to documentation flaws, and you need to appeal or correctly fix the defect.
• Tender Participation: You need confirmation of full compliance to participate in public procurement.
• Adverse Events: An incident occurred during device usage, and you need legal protection from liability.

Georgian Legal Framework

The field is regulated by the Law of Georgia "On Medicines and Pharmaceutical Activities" and the Government Decree "On Approval of the Technical Regulation for Medical Devices." Registration procedures are carried out by the Agency for Regulation of Medical and Pharmaceutical Activities. Legislation is largely harmonized with EU regulations (MDR).

Process: How Collaboration with a Specialist Works

The registration process includes:

1. Analysis: Studying the product and manufacturer's documentation.
2. Preparation: Compiling the dossier, translation, and notarization.
3. Submission: Submitting the application to the Agency.
4. Communication: Responding to Agency remarks and correcting deficiencies.
5. Completion: Receiving the registration certificate and market access.

Why Choose Legal.ge?

Medical device regulations in Georgia are new and complex. Legal.ge connects you with experts who have experience dealing with the regulator and successfully completing the registration process. We will save your time and avoid financial risks. Find a specialist on Legal.ge.