Peru medical device regulations

Decreto Supremo 020-2024-SA: adapts and updates both reglamentos of Ley 29459 to Ley 32033, requiring pharmacies, drugstores, and laboratories to report commercial prices of medicines and medical devices to the DIGEMID price observatory, and rewriting the advertising articles (191-194, plus a new 194-A) of the device registration reglamento. Ingested as corpus text from El Peruano, the official gazette: considerandos and articles 1-9, with each amended or inserted article of D.S. 014-2011-SA and D.S. 016-2011-SA quoted inside the article that enacts it. The gob.pe/MINSA attachment for the same decree is an image-only scan, so the locator is the gazette rendering.

Decreto Supremo 029-2015-SA: modifies D.S. 016-2011-SA with specific criteria for new and modified device registrations, labeling requirements, terms and definitions, violations and penalties. The previously recorded locator (normas-legales/191856) is actually the page of Resolución Ministerial 694-2016-MINSA; the URL now points to the correct gob.pe page for this decree, whose 8-page official attachment is an image-only scan with no text layer. The El Peruano digital expressions do not close the gap either: the HTML rendering ships 938 U+FFFD replacement characters in the served bytes, and the printed-edition PDF draws the glossary page twice with the two columns interleaved, so corpus publication stays blocked at the parser boundary.

Decreto Supremo 014-2011-SA: rules for pharmaceutical establishments including manufacturers, importers, and distributors of medical devices (operational and licensing requirements). The previously recorded locator (normas-legales/243289) is actually the page of D.S. 015-2011-SA; the URL now points to the correct gob.pe page for this decree, whose 907-page official attachment is an image-only gazette scan with no text layer — corpus publication is blocked at the parser boundary.

Decreto Supremo 016-2011-SA: the Regulation for the registration, control, and sanitary surveillance of pharmaceutical products, medical devices, and health products — the base instrument for medical device registration in Peru (classification, sanitary registry procedures, and requirements). The official gob.pe attachment is a 1,259-page image-only gazette scan with no extractable text layer, so corpus publication is blocked at the parser boundary (no OCR substitute permitted); modified by D.S. 029-2015-SA.

Primary law governing pharmaceuticals, medical devices, and health products in Peru. Establishes the regulatory framework and DIGEMID authority.