Georgia
- Regulatory Authority:
Ministry of Labor, Health and Social Protection of Georgia, Central Executive
Authority in the field of healthcare
Agency for State Regulation of Medical Activity
- Language of labeling and documentation:
Georgian, English, Russian
- Registration period:
National procedure:
2 months
By recognition procedure:
1 month
- Legislations:
Law of Georgia dated 1 December 2022, No.659 “On Medicines and Pharmaceutical Activities”
Law of Georgia dated 12 July 2021, No.6157 “Code on Safety and Free Circulation of Product”
- Following medical devices are subject to registration:
- Test systems (by nosology)
- Allergens (except allergens to certain individuals)
- Reagents (clinical biochemistry and clinical chemistry)
- Serums
- Contraceptive mechanical aids
- Dental materials
- Authorized Representative:
not required
- Certificate validity period:
5 years