North Macedonia medical device regulatory resources

Чл. 131 of the Law on Medicines and Medical Devices requires the device to be entered in the register but fixes no period within which MALMED must decide the application, and no such period was found in the Law or in the 151/2010 rulebook. The clock is therefore the general administrative-procedure period.

Чл. 93 ст. 1 of the Закон за општата управна постапка provides that a first-instance procedure initiated by a party's request is completed in the shortest possible time and at the latest within 30 days of its initiation, "освен кога е поинаку предвидено со закон" (unless a law provides otherwise). Because the device law provides no other period, this residual 30-day period is the period that applies to a чл. 131 application.

Чл. 93 ст. 2 starts the period on the day the party files the request with all the evidence it was obliged to submit, so an incomplete file does not start the clock.

Чл. 94 allows the authority to extend the чл. 93 ст. 1 period once, where the complexity of the matter justifies it, for no longer than the period needed and never by more than 30 days, and requires the extension and its reason to be communicated to the party within the original period. The published row is the unextended 30-day period.

The clock is route-wide: it is fixed for the administrative procedure and does not vary by the device's risk class, which is why the row is bound to the route rather than to a class.

Same route-wide 30-day residual period as the class I row: чл. 131 fixes no decision period and чл. 93 ст. 1 of the Закон за општата управна постапка supplies the 30-day default.

Class II-а, class II-б and class III are filed on the same form (Образец бр. 2), so the submission route carries no class-specific clock.

North Macedonia is not an EU/EEA member state, so no notified-body conformity-assessment clock under MDR Annexes IX–XI applies to this row; the notified-body certificate, where there is one, is produced before the file reaches MALMED.

Same route-wide 30-day residual period as the other class rows.

A class II-б device without an EC certificate must file the risk analysis that чл. 8 of the 151/2010 rulebook requires for classes II-б and III, but that is a dossier requirement and not a separate national clock.

The register entry for a class II-б device is valid for two years under чл. 22 of the 151/2010 rulebook, which is published as registrationValidity rather than as a decision clock.

Same route-wide 30-day residual period as the other class rows.

A class III device and an active implantable medical device get a one-year register-entry validity under чл. 22 of the 151/2010 rulebook, the shortest in the schedule.

Чл. 117 of the Law sends classes II-а, II-б and III, and sterile class I devices and class I devices with a measuring function, through a conformity-assessment procedure that ends in an EC certificate of conformity issued by a notified body, and чл. 119 ст. 3 permits the EC mark to be applied. That certificate is a precondition of the file, not a MALMED clock.