Dominican Republic medical device regulations

Decreto núm. 45-23, issued by Presidente Luis Abinader and dated 14 February 2023 (the closing formula reads "a los catorce (14) días del mes de febrero del año dos mil veintitrés (2023)"), which amends Decreto núm. 117-18 — the Reglamento para la Renovación Automática de los Registros Sanitarios de los Alimentos, Medicamentos, Productos Sanitarios, Cosméticos y de Higiene. Six articles: the amendment, the conditions for automatic renewal (fee paid, registration still in force) with the two PÁRRAFOS on changes to the product and the 15-day correction window, the requirements attached to the application, the three-month pre-expiry filing window and the cancellation that follows a missed one, the effect of filing a modification inside the last six months, and a 120-day deadline for the Ministry to automate the procedures. It is the operative renewal regime for a Dominican sanitary registration, and the instrument that makes renewal automatic rather than a fresh review. The issuer is the Presidency; the authority it addresses is DIGEMAPS, which the text names in full. The file carries an embedded OCR text layer that prints the first article number as "ARTICULO í."; the text is ingested exactly as published, and the block label reads Artículo 1. This amends Decreto 117-18, which is not part of this corpus, so no relationship target is recorded — the amendment is stated here rather than pointed at a row that does not exist.

Ley General de Salud No. 42-01, enacted by the Congreso Nacional, promulgated 8 March 2001 (the closing formula reads "a 10s ocho (8) dias del mes de marzo del aiio dos mil uno"). Six libros, thirteen títulos, thirty-eight capítulos and 170 articles. LIBRO CUARTO, "Del control sanitario de productos y servicios", is the one that matters to a device registrant: its Capítulo VIII covers equipos, prótesis, ortesis, ayudas funcionales and the other devices subject to sanitary control, and the surrounding capítulos cover medicamentos, drogas y sustancias controladas, plaguicidas, bebidas alcohólicas, productos del tabaco and alimentos. Article 109 assigns the control of the import, export, evaluation and registration of those products to the Secretaría de Estado de Salud Pública y Asistencia Social — DIGEMAPS is its successor for medicines, foods and sanitary products. The file is a scan with a damaged embedded OCR layer: the roman numerals are mangled ("CAPITULO 11" for II, "CAPITULO 111" for III, "TITULO v", "SECCION x") and LIBRO uses a digit zero for O. The text is ingested exactly as the authority published it, artefacts included; block labels carry the de-mangled ordinal (Capítulo II rather than "CAPITULO 11") so the table of contents is readable and the citation still lands on the printed passage. The source also skips a printed numeral: in LIBRO CUARTO the capítulos run I, II, IV, V, VI, VII, VIII, IX — there is no CAPÍTULO III — so `cap-4-1-3` carries the label "Capítulo IV", position and printed numeral each stated as they are.