Medical Device Regulations constitute a critical part of healthcare law, ensuring the safety and efficacy of medical equipment on the Georgian market. This field covers everything from simple bandages to high-tech diagnostic machinery (MRI, CT scanners) and implants. For importers, distributors, and manufacturers, navigating the complex regulatory maze is essential for the legal sale of products. Regulations concern registration, certification, labeling, import permits, and operational rules. Non-compliance can lead to product confiscation, fines, and market expulsion, making qualified legal support indispensable.
Specialists on Legal.ge offer comprehensive services regarding medical device regulation, including:
- Market entry strategy: Classifying products and determining relevant regulatory requirements prior to import.
- State registration and recognition: Managing procedures for recognizing foreign certificates (CE Mark, FDA) and registering in the national registry.
- Import permits: Preparing documentation related to customs procedures and obtaining necessary permits.
- Labeling and instruction compliance: Legal audit of Georgian product labels and instructions for use.
- Compliance audit: Checking clinics and distributors for compliance with current technical regulations.
In the real business environment, problems often arise at customs when expensive medical equipment is detained due to incorrect codes or lack of certificates. For example, a company might import dental equipment but be unable to sell it because it lacks instructions in Georgian or a declaration of conformity. Disputes in public tenders are also common, where competitors question the technical specifications and registration validity of each other's equipment. Another scenario involves liability when a defective medical device harms a patient — here it is essential to determine whether it was a manufacturer's defect, improper operation, or importer error.
The regulation of medical devices in Georgia is based on the Law "On Medicines and Pharmaceutical Activities" and government technical regulations. The Government Decree "On the Rule of Issuing Medical Practice Licenses and Inpatient Institution Permits" is significant as it sets equipment standards for clinics. Furthermore, Georgia recognizes certificates issued by regulators of EU and OECD member countries (e.g., FDA, EMA) through a simplified procedure, although this process still requires formal steps. The Law "On Protection of Consumer Rights" also obliges importers to provide full product information in the Georgian language.
Working with a specialist begins with analyzing the product's technical passport. The lawyer determines the device's classification and the best route for registration. When using the recognition regime, the lawyer prepares an application to the Regulation Agency for Medical and Pharmaceutical Activities. If primary registration is required, the process is more complex and involves expertise. During participation in tenders, the lawyer ensures full compliance of tender documentation to avoid disqualification.
Legal.ge allows you to connect with lawyers specializing in pharmaceutical and medical law. The medical device market is strictly regulated, and errors are costly. Our platform's verified specialists will help you overcome bureaucratic barriers so that your products can enter the Georgian market quickly and legally.
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