North Macedonia medical device registration timeline

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.

Чл. 131-а ст. 4 of the Law: the Agency issues a provisional parallel-import approval "во рок од осум работни дена од денот на поднесувањето на барањето со целокупната документација и податоци од ставот 3" — within eight working days of the filing of the request with the complete documentation of ст. 3. The unit published here is working days, as the instrument states it.

Чл. 131-а ст. 5 attaches immediate effect to the provisional approval: with it the wholesaler may take part in public-procurement procedures and conclude delivery contracts for medical devices.

Чл. 131-а ст. 6: within three days of the day of full payment of the fee the Agency issues the parallel-import approval, valid for two years, which contains the data of the provisional approval and repeals it. That three-day period is a payment-triggered step inside the same route and is not published as a separate row.

Чл. 131-а ст. 7 gives the holder 60 days to notify a change to the device in the source country, and ст. 8 gives 15 days to notify a withdrawal from the market there; neither is a first-approval clock.

The parallel-import route is available for a device of any risk class, so it spans classes rather than resolving to one; the fee for it is graduated by the number of products rather than by class (чл. 3 ст. 2 of the Правилник за надоместоци).

Чл. 134 ст. 3 of the Law fixes a 30-day period after which, if the Agency has not decided, the clinical investigation is deemed approved — a tacit-approval clock rather than a decision deadline.

Чл. 134 ст. 4 and чл. 135 ст. 2 each fix a further 30-day period for the steps that follow, so the realistic end-to-end span runs to about two months.

The clock is the same for a device of any risk class and is therefore bound to the route rather than to a class.

The fee for a clinical-investigation approval or notification, and for the accompanying Ethics Committee opinion, is 240 euro each under чл. 6 of the Правилник за надоместоци.

Three separate statutory periods of 90 days, each expressed as a duty to inform the applicant of its entry in the register: чл. 123 ст. 2 "Агенцијата во рок од 90 дена го информира производителот за неговото запишување во регистарот на производители", чл. 129 ст. 1 "Агенцијата во рок од 90 дена е должна да го извести правното лице за запишувањето во регистарот на правни лица за промет на големо", and чл. 130 ст. 6 the same wording for the register of specialised retail shops.

Each of the three is qualified the same way: the period stops running on the day the Agency asks the applicant for additional documentation or data it considers necessary, and resumes on the day that request is satisfied (чл. 123 ст. 3, чл. 129 ст. 2 and чл. 130 ст. 7). The published 90 days is therefore the period on a complete file, and a request for further documentation suspends it rather than extending it by a fixed amount.

These are operator registrations, not device approvals: a foreign manufacturer's device still needs its own чл. 131 register entry, and its local representative must itself satisfy the wholesale-trade conditions or be a branch or trade representation of the foreign manufacturer (чл. 8 of the 151/2010 rulebook).

The clock does not vary with the risk class of any device, which is why the row is bound to the route rather than to a class.

The wholesale register entry carries a 471 euro fee and the specialised-retail register entry 160 euro under чл. 8 of the Правилник за надоместоци as amended.