Medical Device Registration in Georgia

The Georgian medical device market presents a significant opportunity for international companies looking to expand their presence in the Caucasus region. With a growing healthcare sector and increasing demand for innovative medical technologies, Georgia offers a promising environment for the registration and sale of medical devices.

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In 2020, the Georgian medical device market was estimated at approximately USD 100 million, with a projected annual growth rate of 7-9% over the next five years.

In this guide we aim to provide a detailed overview of the medical device registration process in Georgia, enabling regulatory professionals to make informed decisions and streamline their market entry strategies.

Overview of regulatory authorities and laws

The main regulatory body overseeing medical devices in Georgia is the State Regulation Agency of Medical Activities (RAMA), which operates under the Ministry of Internally Displaced Persons from Occupied Territories, Labour, Health and Social Affairs (Ministry of Health). The RAMA is responsible for enforcing the rules established by the Ministry of Health through:

Granting marketing authorizations for medical devices
Managing the registry of medical devices
Ensuring the removal of non-compliant devices from the market
Conducting inspections of medical device manufacturing facilities and distribution channels
Monitoring the quality and safety of marketed devices through post-market surveillance activities

Key legislation governing medical device registration in Georgia includes:

The Law of Georgia on Medical Devices (2020)
- Establishes the legal framework for the regulation of medical devices
- Defines the roles and responsibilities of the Ministry of Health and RAMA
- Sets out the requirements for the registration, manufacture, import, and distribution of medical devices
Decree No. 585 on the Registration of Medical Devices (2020)
- Outlines the specific requirements and procedures for the registration of medical devices
- Defines the documentation and data required for registration applications
- Specifies the timelines and fees associated with the registration process

Engaging local regulatory experts, such as Delta Medical, can help manage the local complexities of Georgian medical device legislation and streamline the registration process.

Classification of medical devices

Georgia follows a risk-based classification system for medical devices, which is harmonized with the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Medical devices are classified into four categories based on their intended purpose, duration of use, and potential risks:

Class I: Low-risk devices (e.g., non-sterile bandages, tongue depressors)
Class IIa: Low-to-medium risk devices (e.g., hearing aids, dental fillings)
Class IIb: Medium-to-high risk devices (e.g., ventilators, bone fixation plates)
Class III: High-risk devices (e.g., heart valves, drug-eluting stents)

The classification of a medical device determines the applicable conformity assessment procedures and the level of regulatory oversight required for registration.

Registration Pathways for Medical Devices

Georgia offers two main registration pathways for medical devices:

Simplified registration procedure
- Applicable for devices that have been CE marked under the EU’s MDR or IVDR
- Requires submission of administrative documents, including:
  - CE certificate and Declaration of Conformity
  - Instructions for use and labeling in Georgian
  - Proof of payment of the registration fee
- Examination and registration can be completed within 30 calendar days
- Registration is valid for 5 years or until the expiration of the CE certificate, whichever comes first
Standard registration procedure
- Applicable for devices that do not have a CE mark or are not covered by the simplified procedure
- Requires submission of a more extensive set of documents, including:
  - Technical documentation (device description, intended use, design and manufacturing information, risk analysis, clinical evaluation)
  - Quality management system (QMS) documentation
  - Labeling and instructions for use in Georgian
  - Proof of payment of the registration fee
- Examination and registration process can take up to 90 calendar days, excluding time for the applicant to address queries
- Registration certificate is valid for 5 years

It is important to note that the simplified registration procedure can significantly reduce the time and resources required for registration, making it an attractive option for devices already approved in the European Union.

Required Documentation and Submission Process for Medical Devices in Georgia

To successfully register a medical device in Georgia, regulatory managers must prepare a comprehensive dossier containing both administrative and technical documentation.

The specific requirements may vary depending on the chosen registration pathway (simplified or standard), but the following key documents are generally required:

Administrative documents

Application form and fees
- Completed application form in Georgian or English
- Payment of the applicable registration fees (e.g., 500 GEL for the simplified procedure, 2000 GEL for the standard procedure)
CE certificate and Declaration of Conformity (for simplified procedure)
- Valid CE certificate issued by a Notified Body under the EU’s MDR or IVDR
- Signed Declaration of Conformity by the manufacturer
Labeling and instructions for use
- Proposed labeling and packaging materials, including mock-ups, in Georgian
- Instructions for use (IFU) in Georgian
Power of Attorney and ISO 13485 certificate
- Notarized Power of Attorney authorizing a local representative to handle the registration process
- Valid ISO 13485 certificate for the manufacturer’s quality management system

Technical documentation (for standard procedure)

Device description and intended use
- Detailed description of the device, including its composition, materials, and principles of operation
- Intended use, indications, contraindications, and target patient population
Design and manufacturing information
- Design inputs, outputs, and verification/validation data
- Manufacturing process flow, including key suppliers and subcontractors
- Sterilization and packaging validation, if applicable
Risk analysis and clinical evaluation
- Risk management file, including risk analysis, evaluation, and control measures
- Clinical evaluation report, demonstrating the device’s safety and performance
- Post-market surveillance plan and periodic safety update reports (PSURs)
Quality management system (QMS) documentation
- Quality manual and key procedures related to design control, document control, production and process control, and corrective and preventive actions (CAPA)
- List of standards applied in the design and manufacture of the device

Submission Format and Language Requirements in Georgia

The administrative part of the dossier must be submitted in Georgian or English
The technical documentation can be submitted in Georgian, English, or Russian
Electronic submission of the dossier (e.g., via CD-ROM or email) is generally accepted, but hard copies may be required upon request

Regulatory managers should work closely with their local partners and experts to ensure that all required documents are obtained, translated, and submitted in accordance with Georgian requirements.

Post-registration obligations and market surveillance in Georgia

Once a medical device has been successfully registered in Georgia, manufacturers and authorized representatives must comply with various post-registration obligations to maintain their license and ensure the continued quality, safety, and performance of their devices.

Labeling requirements in Georgia

All medical devices must be labeled in Georgian when placed on the market
Labels must include essential information such as the device name, manufacturer, intended use, lot/serial number, expiry date (if applicable), storage conditions, and warnings or precautions
Any changes to the approved labeling must be submitted to the RAMA for approval prior to implementation

Reporting changes and modifications

Manufacturers must notify the RAMA of any significant changes or modifications to the registered device that could affect its safety, performance, or intended use
Changes are classified into minor and major categories, each with specific submission requirements and timelines
Manufacturers must assess the impact of the proposed changes on the device’s risk profile and provide supporting documentation as necessary

Vigilance and adverse event reporting

Manufacturers and authorized representatives are responsible for continuously monitoring the safety and performance of their devices and reporting any incidents, near-incidents, or field safety corrective actions (FSCAs) to the RAMA
Serious incidents must be reported within 2 calendar days, while other incidents and FSCAs must be reported within 10 calendar days
Manufacturers should establish a robust vigilance system to collect, evaluate, and report post-market data

Market surveillance and inspections

The RAMA conducts regular market surveillance activities to ensure that medical devices comply with the applicable regulations and standards
This may include inspections of manufacturing facilities, distribution channels, and healthcare institutions where the devices are used
Manufacturers and authorized representatives must cooperate with the RAMA during inspections and promptly address any identified non-conformities

Renewal and cancellation of registration

Medical device registrations are valid for 5 years from the date of issuance
Manufacturers must submit a renewal application to the RAMA at least 2 months before the expiration of the current registration
The RAMA may cancel or suspend a registration if the device is found to be non-compliant, unsafe, or ineffective, or if the manufacturer fails to meet its post-registration obligations

Key Takeaways and Helpful Resources

By following the steps we have discussed, international regulatory managers can manage the Georgian medical device regulatory process more effectively and efficiently.

Key takeaways for successful medical device registration in Georgia include:

Determining the appropriate classification and registration pathway for the device
Preparing a complete and well-organized registration dossier that meets Georgian requirements
Engaging local partners and experts to support the registration process and ensure compliance
Establishing robust vigilance and quality management systems to maintain the registration and ensure patient safety

To stay updated on the latest regulatory developments and industry trends in Georgia, regulatory managers can consult the following resources:

By leveraging these resources and partnering with experienced local service providers like Delta Medical, international medical device companies can confidently enter the Georgian market and contribute to the country’s growing healthcare sector.