Georgia medical device regulatory resources

Article 3(7) of the technical regulation: the Agency issues the registration certificate within 20 working days of submission of the application.

Article 3(8) adds 5 working days after a positive decision to enter the investigation in the register, which is public.

Article 3(9) makes registration a precondition of starting the investigation. Documents must be in Georgian or carry a notarised Georgian translation.

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.

Healthy volunteers may take part only in clinical investigations of non-invasive class I devices (Article 6(4)), and a clinical investigation involving medical devices may not be carried out on a foreign national (Article 6(5)).

Investigations must follow the Helsinki Declaration, ICH GCP and ISO 14155:2020 (Article 3(2)).

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.

Article 11^11(10): if the applicant is not notified of a refusal within the statutory period the product is considered registered, and the marketing-authorisation document must be issued within 10 days of the administrative act.

This clock belongs to the Law on Medicines registration route, which reaches medical goods only through the three device-type categories named in Article 11^11(19)(d) and (20)(i)-(k). General medical goods are outside it, and no equivalent statutory clock exists for them because no general device review exists.

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.

Article 11^11(16): circulation is permissible for 5 years after registration, and after expiry of the registration validity period until expiry of the shelf life of the batches placed on the market; Article 11^11(15) revokes the marketing-authorisation document when the validity period expires.

On re-registration the applicant files the Article 11^11(9) documents plus at least four years of side-effect data from the five-year authorisation period (Article 11^11(7)).