North Macedonia medical device regulations

Правилникот за начинот за известување на несаканите ефекти за време на користењето на медицинското средство, видовите на реакциите што ги предизвикуваат, постапувањето на здравствените работници и добавувачите, како и начинот на организирање на системот за следење на несаканите ефекти и реакциите од медицинските средства, „Службен весник на РМ“ бр. 100 од 23.05.2016, бр. 02-4843/3. It is North Macedonia’s materiovigilance instrument: fifteen articles in four chapters — I. ОПШТИ ОДРЕДБИ; II. МАТЕРИОВИГИЛАНЦА ВО КЛИНИЧКО ИСПИТУВАЊЕ НА МЕДИЦИНСКО СРЕДСТВО; III. МАТЕРИОВИГИЛАНЦА НА МЕДИЦИНСКИТЕ СРЕДСТВА ВО ПРОМЕТ; IV. НАЧИН НА ОРГАНИЗИРАЊЕ НА СИСТЕМОТ ЗА СЛЕДЕЊЕ НА НЕСАКАНИТЕ ЕФЕКТИ И РЕАКЦИИ — and it is the rulebook that decides what a manufacturer established in or represented in North Macedonia must report, to whom, and within what period. Chapter ids are positional (`sec-1`, `sec-4`, `sec-10`, `sec-15`) while the labels keep the printed Roman numerals.

Правилникот за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, „Службен весник на РМ“ бр. 188 од 02.11.2015, бр. 02-7981/3 of 28 October 2015, signed by the acting director Marija Darkovska-Serafimovska and since amended by „Службен весник на РМ“ бр. 217/16 and „Службен весник на РСМ“ бр. 143/22, 86/2025 and 110/2026 (only the two latest touch the device articles). It is the fee rulebook for every procedure the Agency conducts, medicines and devices together. As gazetted it has sixteen articles and twelve numbered headings — 1. Надоместоци за одобрение за ставање на лек во промет through 12. Надоместоци за вршење на стручна процена на документацијата — of which **heading 10, Надоместоци за запишување во регистарот на медицински средства, and Article 11 are the device part**: Article 11 sets the device register fee per product by CE-marking status and by the number of products filed under one protected or generic name by one manufacturer (40 EUR per product up to 25 products, 24 EUR up to 100, 8 EUR above 100, and a separate scale for devices without a CE mark). Heading 12 is the general fee for the Agency’s expert assessment of documentation. The article heads are matched on the plural forms only, because the numbering also runs through in-article items — `1. Надоместок за издавање на одобрение за производство за одреден тип и модел на` is a list item inside an article, not a heading — and segmenting on blank lines alone would have split it out as a thirteenth heading. Ingested from the MALMED PDF of the gazette. The two amending rulebooks are ingested as separate rows, not folded into this text.

Правилникот за изменување и дополнување на Правилникот за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, „Службен весник на РСМ“ бр. 110 од 22.5.2026, бр. 03-6470/3 of 19 May 2026, signed by the director Sabri Aliti. Two articles: Article 1 substitutes „471 евра во денарска противвредност“ for „500 евра во денарска противвредност“ in Article 8(1) and 8(5) of the 2015 rulebook as already amended by 86/2025, and Article 2 is the entry into force (the day after publication). Article 8 is a medicines fee heading, so this amendment **does not touch the device register fees** that 86/2025 had just set at Article 11; it is ingested because the fee rulebook it amends is the device fee instrument and a reader of that text needs the current state of it.

Правилникот за изменување на Правилникот за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, „Службен весник на РСМ“ бр. 86 од 28.4.2025, бр. 03-4311/4 of 25 April 2025, signed by the acting director Sefedin Jonuzi. Three articles, and it is the one device-relevant amendment in the pair: Article 1 deletes the words „(по параметар)“ from Article 2 point 5 line 1 of the 2015 rulebook, and **Article 2 replaces Article 11 — the device register fees — with a fee per device class** (class I 300 EUR in denar equivalent, class II-a 400 EUR, class II-b 400 EUR and the further classes the text sets out), so the fee for entering a device in the register moved from the per-product CE-marking scale of 2015 onto a class-based one. Article 3 is the entry into force (the eighth day after publication). Ingested as its own row rather than folded into the consolidated text of the 2015 rulebook, so the amendment history stays visible in the corpus.

Правилникот за содржината на образецот на барањето и потребната документација која треба да се достави за запишување на медицинските помагала во регистерот на медицински помагала во Република Македонија, „Службен весник на РМ“ бр. 151 од 22.11.2010, бр. 15-6710/1 of 15 November 2010 — issued by the Министерство за здравство, which is why the ministry rather than the Agency is named as the publisher on this row. It prescribes the application form and the documentation for entering medical aids in the register: twenty-four articles in two parts (I. Општа одредба; II. Обрасците на барањата за запишување) and a final provision, with the four annexed Образци setting out the application, the statement of the manufacturer or importer, and the two supporting declarations. **Only the twenty-four articles are ingested.** Pages 12 to 32 of the 32-page PDF are the four annexed forms, and they are page images with no text layer at all — confirmed with `pdfimages -list`, which finds three images on page 13 alone — so no form content exists in the served bytes to segment. **The printed article numbering skips Член 9** (the headings run 8, then 10), even though `член 9 став 3 алинеја 14` is cited inside Член 10; the extract keeps the printed numbers and does not invent a ninth article. The section ids are positional (`sec-1`, `sec-3`, `sec-25`) rather than the printed numerals, because the rulebook prints „II.“ twice — once for the forms part and once for the final provision.

The Law on Medicines and Medical Devices as a consolidated text — MALMED’s own .docx assembly of 23 source acts, from the basic text in „Службен весник на РМ“ бр. 106/07 to „Службен весник на РСМ“ бр. 267/25. The publisher marks it неофицијален (unofficial), and that wording is kept in the record’s title and here rather than being presented as the gazette’s own consolidation; the amended-date field records the last source act, not a date the document states about itself. Chapter IV МЕДИЦИНСКИ СРЕДСТВА is the device part, running from Article 110 to Article 140 in the consolidated text’s own numbering, in ten sub-chapters: IV.1 classification; IV.2 essential, general and particular conditions; IV.3 conformity assessment; IV.4 marking; IV.5 manufacture; IV.6 distribution; IV.7 materiovigilance; IV.8 advertising; IV.9 donations — with the printed numbers IV.5 and IV.6 each used twice, marking and clinical investigation both being labelled IV.5, and distribution and clinical investigation both IV.6. Chapter V НАДЗОР opens at Article 141; the medicines chapters (I to III) are ingested with it because the two are one statute and the device provisions cross-refer to the Agency, the register and the inspection chapters. Structure as ingested: a preamble block; 31 chapter blocks (ch-i to ch-vii with the source’s own decimal sub-chapters — ch-iii-2 to ch-iii-11 and ch-iv-2 to ch-iv-12 — plus ch-vi-а for the later КАЗНЕНИ ОДРЕДБИ); 207 article blocks; and 23 `drugi-zakoni-1` to `drugi-zakoni-23` section blocks carrying the ОДРЕДБИ ОД ДРУГИ ЗАКОНИ appendix, which is where each amending act’s own transitional and final provisions are printed. **Three defects in the source are carried, not repaired.** (1) The chapter numbering repeats: the printed IV.5 and IV.6 each head two different chapters, so the ids take a positional suffix (`ch-iv-7`, `ch-iv-8`) and the printed labels are left as they are. (2) `Член 156-ѓ` is printed twice, so the second copy takes the id `art-156-ѓ-2`. (3) Five articles — Член 142, 142-а, 143, 144 and 145 — are printed as `(Избришан)` with their numbers retained, and the block ids keep those numbers rather than closing the gaps. The consolidated text’s table of contents (`Содржина:`, 33 entries) is **not** ingested: it duplicates the chapter and article headings, and the corpus carries no table-of-contents blocks anywhere, so it is treated as navigational furniture. Ingested from the .docx MALMED serves, reading the paragraphs directly out of `word/document.xml`.