Georgia medical device registration timeline

Source-linked clocks

LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA) (Regulation Agency for Medical and Pharmaceutical Activities (RAMA)) review clocks and end-to-end planning ranges, using the Four-class axis (I, IIa, IIb, III) set by Annex No. 1.1 to the medical-device clinical-investigation technical regulation, Government Decree No. 386 of 3 October 2023 classification system.

4 pathways4 of 4 clocks verifiedvalidity Clinical-investigation registration certificate — issued for the period requested by the applicant, corresponding to the investigation plan and the insurance period (Decree No. 386, Article 3(10)). Marketing authorisation for a registered product — circulation permissible for 5 years after registration (Law on Medicines, Article 11^11(16)).MDSAP not acceptedreviewed 2026-09-16matsne.gov.ge

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I — clinical-investigation registration(Application to the Agency; registration certificate issued by decision of the Agency) Article 3(7) of the technical regulation: the Agency issues the registration certificate within 20 working days of submission of the application.	20 working days	2-4 months	—	Verified
Classes IIa, IIb and III — clinical-investigation registration on a Council recommendation(Application to the Agency; registration only on the positive recommendation of the Coordination Council for clinical investigations of medical devices) The same 20-working-day clock of Article 3(7) applies, but for these three classes Article 3(5) interposes a prior step the clock does not cover: the Agency registers the investigation only on the positive recommendation of the Coordination Council, which is why the planning range is longer than for class I.	20 working days	4-8 months	—	Verified
Any class — primary state registration under the Law on Medicines (national regime)(National regime of state registration, for the device-type categories the Law on Medicines registers: dental material, invasive mechanical means of contraception, and means of diagnostics) Article 11^11(9): during the registration procedure the Agency decides to register or refuse within 3 months for the primary registration of a product or the registration of a Type-II variation. Article 11^11(8) counts every period from the date a complete set of registration documents is submitted.	3 months	5-9 months	—	Verified
Any class — re-registration and registration-and-recording under the Law on Medicines(National regime of state registration, re-registration after expiry of the five-year validity period) Article 11^11(9): the Agency decides within 2 months in the case of re-registration or of the registration and recording of a product.	2 months	4-7 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Georgia Medical Device Registration Process

Step-by-step Regulation Agency for Medical and Pharmaceutical Activities (RAMA) registration process. Total estimated timeline: 2-4 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by Regulation Agency for Medical and Pharmaceutical Activities (RAMA). Appoint a For a clinical investigation, the sponsor's authorised person in Georgia — its official representation in Georgia or a clinical research organisation (CRO) registered in Georgia, which is the applicant under Article 4(7) of the clinical-investigation technical regulation; for state registration under the Law on Medicines the applicant is an interested person such as the manufacturer, a trade licence holder or an importer.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to Regulation Agency for Medical and Pharmaceutical Activities (RAMA) including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

Regulation Agency for Medical and Pharmaceutical Activities (RAMA) reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

20 working days

In-depth technical assessment of device safety and performance. Regulation Agency for Medical and Pharmaceutical Activities (RAMA) may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, Regulation Agency for Medical and Pharmaceutical Activities (RAMA) issues Georgia market authorization certificate.

Summary: The Georgia medical device registration process through LEPL Regulation Agency for Medical and Pharmaceutical Activities (RAMA) (Regulation Agency for Medical and Pharmaceutical Activities (RAMA)) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

US FDA 510(k)/PMANo recognition or abridged route for medical goods: the Law on Medicines recognition regime is written for pharmaceutical products and the only state-registration rule for medical technical items was repealed in 2012 without a successor. An FDA clearance is not a route onto the Georgian market; where a device is registered under the Law on Medicines it can serve as origin-country documentation alongside the ISO/EC certificate or free-sale certificate the dossier accepts in place of a certificate of pharmaceutical product.

EU CE marking under MDR/IVDRNo recognition route for devices. An EC certificate of the product manufacturer is, however, expressly accepted in the administrative dossier of the three device-type categories registered under the Law on Medicines in place of a certificate of pharmaceutical product (Article 11^11(19)(d)), which is documentary relief rather than an approval. Georgia separately recognises EU technical regulations as such under Article 56(11) of the Product Safety and Free Movement Code.

EAEU marketing authorisationGeorgia is not a member of the Eurasian Economic Union and recognises no EAEU medical-device marketing authorisation.

MDSAPNo MDSAP acceptance was evidenced in any Georgian instrument read this round; the clinical-investigation technical regulation names the Helsinki Declaration, ICH GCP and ISO 14155:2020 as the applicable standards and does not name MDSAP.

Key requirements

Establish whether the device is regulated at all: general medical goods (instruments, devices, appliances, medical equipment, dressing material, prosthetic and orthopaedic products) have no general pre-market registration in Georgia, while dental material, invasive mechanical means of contraception and means of diagnostics are registered under the Law on Medicines.
For a device under clinical investigation, file the application with the Agency in the form the Agency sets, with the registration fee receipt, the manufacturer's evidence of conformity with the applicable standard, the labelling indicating that the device is for investigation, and the other Article 7(1) documents, all in Georgian or with a notarised Georgian translation.
Appoint the sponsor's authorised person in Georgia — its official representation in Georgia or a clinical research organisation registered in Georgia — as the applicant for a clinical-investigation registration (Decree No. 386, Article 4(7)).
Register the clinical investigation before it starts; for classes IIa, IIb and III obtain first the positive recommendation of the Coordination Council for clinical investigations of medical devices (Decree No. 386, Articles 3(5), 3(7) and 3(9)).
Report suspected unexpected serious adverse reactions to the Agency within 7 calendar days for fatal or life-threatening cases and 15 calendar days otherwise, and file a summary safety report annually for multi-year investigations (Decree No. 386, Article 7(11)).
Where a Georgian marketing authorisation is required for one of the three registered device-type categories, file the administrative part of the dossier including the application, the certificate of pharmaceutical product or an ISO or EC certificate of the manufacturer or a free sale certificate in its place, the packaging and labelling sample, the Georgian-language patient information leaflet and the registration fee receipt (Law on Medicines, Article 11^11(19)).
Where the device is radio equipment, have it certified by an accredited centre or laboratory under the GNCC certification regulation and carry the CE or GES conformity marking and the responsible body's identification number before placing it on the market (Law on Electronic Communications, Articles 58(2) and 59; GNCC Decree No. 2, Article 16).
Where the equipment uses the radio-frequency spectrum, hold the spectrum-use authorisation, licence or scarce-resource right from the Commission before operating it (Law on Electronic Communications, Article 43(4)).
Where the device is non-infectious, non-implantable electrical or electronic equipment, register in the extended-producer-responsibility electronic registry before placing it on the Georgian market, and obtain Ministry authorisation for an individual compliance scheme (Government Decree No. 326 of 2020, Articles 6(1) and 7(5)).
Where dental, intraoral or osteodensitometry X-ray diagnostic equipment is used, hold the Nuclear and Radiation Safety Agency's authorisation and comply with the radiation-safety technical regulation's dose-monitoring, diagnostic-reference-level and quality-assurance duties (Law No 3284-XIმს-Xმპ, Articles 16(2) and 19(1); Government Decree No. 77 of 17 March 2025, Articles 31(5) and 32-33).

Primary regulator sources

matsne.gov.ge · Government Decree No. 386 of 3 October 2023 — technical regulation on clinical investigations of medical devices, Article 3(5) to (10) matsne.gov.ge · Law of Georgia on Medicines and Pharmaceutical Activities, Article 11^11(8) to (10) and (16) — Agency decision deadlines, deemed registration and the five-year circulation period

Reviewed 2026-09-16. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against Regulation Agency for Medical and Pharmaceutical Activities (RAMA) publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:georgia:clinical-investigation-class-i