Does my medical device need AMDM entry in the State Register of medical devices in Moldova?

Maintained country rule

What this AMDM entry in the State Register of medical devices check is screening

Separates reusable product approval from consignment, customs, PVoC, CoC, and HS-code documents. Handled as an import or shipment-level obligation.

Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.

Requirement family

Import conformity and shipment certificates

Regulatory object

finished device

Maintained rule status

mandatory at import

Useful product facts

HS code for every shipped object, shipment purpose, importer, origin, product certificate, and consignment details.

Placement on the Moldovan market runs through the State Register of medical devices kept by AMDM. Devices bearing the CE marking are placed on the market by way of the registration procedure (AMDM's 'Despre dispozitive medicale' page), and devices without the CE marking are registered under the procedure made in accordance with art. 8 of Legea nr. 102 din 9 iunie 2017, whose point 5 records the entry of the device data in the State Register and whose point 6 gives the registration within up to 30 days from payment; point 12 requires the dossier on paper and electronically with a declaration of truthfulness, and point 8 requires the holder to notify the Agency of any change after registration, including cessation of placing on the market. The dossier is filed at the Agency's single desk after a prior validation of the registration form (point 2), and the Agency may verify the truthfulness of the information and documents by requesting additional documents and consulting information sources (point 3). The procedures and the tariff table were read in full.