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Medical Device Regulations

Does Georgia recognize CE marking and FDA approval?

Yes, Georgia has a "Recognition Regime" which simplifies registration for products already approved by stringent regulatory authorities like the EU (CE mark) or US FDA. Under this regime, you don't need to repeat clinical trials; you primarily submit proof of foreign authorization. We facilitate this streamlined process.

What is the timeline for medical device registration?

Under the recognition regime, the timeline is relatively short, typically 7-20 business days after submitting a complete dossier. However, for the national registration regime (if no foreign approval exists), it can take several months. We help you choose the fastest legal route.

Can I import used medical equipment?

Yes, but it is strictly regulated to ensure patient safety. You must provide a document confirming the device's residual resource (lifespan), proof of refurbishment, and a warranty. Importing "scrap" equipment is prohibited. We ensure your documentation meets these specific criteria.

Is a local authorized representative required?

Foreign manufacturers must appoint a local authorized representative or distributor in Georgia who will be legally responsible for the product's safety and post-market surveillance. We can draft the representative agreement to clearly define liabilities.

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Medical Device Regulations and Market Access in Georgia

The medical technology sector in Georgia is developing rapidly, increasing the demand for quality and safe medical devices. Unlike pharmaceuticals, Medical Device regulation covers a broad spectrum of products — ranging from simple bandages and syringes to high-tech diagnostic equipment and implants. Georgia is gradually harmonizing its legislation with EU regulations (MDR - Medical Device Regulation), presenting new challenges for importers and manufacturers. Placing a product on the market requires correct classification, conformity assessment, and state registration (in certain cases) or notification procedures.

Legal.ge offers comprehensive legal support regarding medical device regulations. Lawyers on our platform will assist you in product classification, technical documentation preparation, and interaction with the regulatory body. Our goal is to ensure the lawful and smooth import and distribution of your products within Georgian territory.

What Does Medical Device Regulations Service Cover?

Our service covers all regulatory aspects of the medical device lifecycle:

  • Classification and Conformity Assessment: Determining the device's risk class (I, IIa, IIb, III) according to Georgian legislation, which dictates the strictness of regulation.
  • Market Authorization: Preparing and submitting the registration dossier to the Regulation Agency for Medical and Pharmaceutical Activities (import permit/recognition regime).
  • Labeling and Instructions: Adapting packaging and Instructions for Use (IFU) into Georgian, complying with technical regulation requirements.
  • Declaration of Conformity: Verifying the validity of the EU Declaration of Conformity and CE marking for the Georgian market.
  • Post-Market Surveillance: Setting up an incident (defect) reporting system and communicating with the regulator in case of product recalls.
  • Promotional Material Review: Legal assessment of medical device advertising to prevent misleading consumer information.

Common Situations and Scenarios

A typical scenario involves the import of used medical equipment. A clinic wants to buy a refurbished CT scanner from Europe. Legislation strictly regulates the import of used equipment, requiring proof of residual resource and manufacturer certificates. A lawyer helps the client perfect the documentation so the cargo doesn't get stuck at customs.

Another current issue is Software as a Medical Device (SaMD). Many developers create health apps without realizing they classify as medical devices. A lawyer assesses the app's functionality and determines if it requires registration, protecting the company from illegal activity.

Georgian Legislation and Legal Framework

The field is regulated by the Law on Medicines and Pharmaceutical Activities (in part), the Code on Product Safety and Free Movement, and Government technical regulations. Crucial is Government Decree No. 585 "On Approval of the Technical Regulation on Medical Devices," based on European directives. Import procedures are outlined in the Customs Code and orders of the Minister of Health.

Process of Receiving Services

The process begins with an audit of the product's technical passport and international certificates (ISO 13485, CE Mark). The lawyer determines the classification and sets an action plan. For imports, documentation is prepared for permits or admission via the recognition regime. A Legal.ge specialist ensures communication with the Regulation Agency and Revenue Service (Customs). With our help, you avoid fines and product confiscation.

The medical device market is complex, but with the right legal partnership, it is profitable and safe.

Why Choose a Specialist on Legal.ge?

Medical device regulation requires a synthesis of technical and legal knowledge. Legal.ge gives you access to experts who understand the difference between Class I and Class III devices and know how to format technical files in accordance with Georgian law.

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