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Medical Device Regulation

Is registration mandatory for all medical devices?

Yes, all medical devices must be registered to be allowed on the Georgian market, with rare exceptions provided by law.

What is the recognition regime?

If a product is registered in the EU or USA, it undergoes simplified registration (recognition) in Georgia, which is completed in 7 working days.

What language should the label be in?

The label and instructions for use must be in the Georgian language. Combination with other languages is allowed.

How much is the state fee?

The fee for registration under the national regime is 500 GEL, and under the recognition regime, it is also 500 GEL.

Reading Time

2 min

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Medical device regulation and registration in Georgia is a growing and rapidly changing field. The country is actively harmonizing its legislation with EU directives (MDR/IVDR), imposing new, strict requirements on importers and distributors. Placing a medical device on the market requires proof of its safety and efficacy, state registration, and compliance with labeling rules. Importing or selling devices without a permit is illegal and leads to product confiscation and fines. Qualified lawyers will help you navigate the complex regulatory maze and ensure the legal status of your products.

What does the Medical Device Regulation service cover?

Specialists on Legal.ge offer full support for market access of medical products:

  • State Registration: Preparing and submitting full documentation to the State Regulation Agency for Medical Activities of the Ministry of Health.
  • Classification: Determining the device class (I, IIa, IIb, III) based on risk, which dictates the complexity of the registration procedure.
  • Documentation Adaptation: Translating and adapting instructions for use, labels, and technical passports to meet Georgian legislative requirements.
  • Recognition Regime: Utilizing simplified registration procedures if the device is already authorized in countries with strict regulatory regimes (USA, EU).
  • Clinical Trials: Legal support in obtaining permits for clinical trials (if necessary).
  • Post-Market Surveillance: Setting up an adverse event reporting system and communicating with the regulator.

Common scenarios when you need this service

Legal assistance is necessary in the following cases:

  • You are starting to import a new brand of medical equipment (e.g., ultrasound machine, laser).
  • You want to enter medical consumables (syringes, gloves) into a state tender.
  • Cargo has been detained at customs due to lack of registration.
  • Notarized translation and legalization of instructions into Georgian is required.

Georgian Legislation and Regulations

The main regulator of the field is the Law "On Medicines and Pharmaceutical Activities", as well as the Government Decree "On Approval of Technical Regulations for Medical Devices". These acts establish registration rules, labeling requirements, and market surveillance mechanisms. The registration body is the Regulation Agency for Medical and Pharmaceutical Activities.

Service Delivery Process

  1. Audit: Reviewing the product dossier (technical file).
  2. Preparation: Translating and notarizing documents.
  3. Submission: Filing the application with the Agency.
  4. Receipt: Obtaining the registration certificate.

Why choose a specialist on Legal.ge?

Registration of medical devices requires specific knowledge in pharmaceutical law. Incorrectly filled documentation leads to registration refusal and months of delay. Legal.ge gives you access to experts who ensure a fast and smooth process.

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Specialists for this service

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