El Salvador medical device regulations

Official SRS medical-device post-registration modification application, version 02, expressly effective 4 September 2025. All three rendered pages retain the requested change matrix, electronic-submission indications, third-party fields, responsible-person signatures and notarial instructions. Later notices and guides must be read alongside this expression; this review does not establish present validity.

Complete five-page SRS guide, version 02, expressly effective 4 September 2025. Specifies general requirements and individual changes to presentations, intended use, registration holders, manufacturers, manufacturing sites, specifications, labelling, renewals and cancellation. This operational guidance is distinct from the underlying RTS and its legal references.

Selected fee provisions for medical-device and other health-technology registration and changes, device laboratory testing, imports and exports, device manufacturers and importers, and relevant quality-system services. Includes the general payment, renewal, repeal and commencement provisions. Article 10 expressly repeals Decree 417. Recital II dates that decree 1 July 2013, while operative Article 10 dates it 11 July 2013; the discrepancy is retained. The legislative signature is dated 19 September 2023, the presidential publication order 27 September 2023 and the Gazette 6 October 2023, with a separate editorial notation of 31 October 2023. Article 11 enters into force on 1 January 2024 and phases renewal and market-surveillance charges at 50% in 2024, 75% in 2025 and 100% in 2026. Other product fee tables remain outside this selected expression. Later fee amendments and the relationship with SRS tariffs remain unverified.

Official SRS declaration for registered products not distributed or marketed during the preceding year, with a five-row blank product-register annex. Medical-device relevance follows the URDM tools listing and the device market-surveillance fee context in Decree 846; the template also covers other regulated products. Applicable later fee changes and current use remain unverified.

Complete three-page SRS guide for registration certificates, non-registration attestations and free-sale certificates. Its scope includes regulated medical devices. Retrieved from the official URDM guide directory, with the printed version retained without inferring a legal commencement date.

Complete 41-page SRS classification instruction, version 01, including general device and IVD classification rules, examples, decision processes and incorporated annex material. Acquired from the current official URDM instructions directory.

Announces monitoring of medical-device advertising from March 2025 for consistency with the characteristics and intended uses authorized in the sanitary registration. It identifies three prohibited types of claims. This concerns advertising oversight, separately from adverse-event reporting.

Announces the 2025 annual renewal and market-surveillance maintenance payments, expressly including medical devices. Payment without surcharge is due by 31 March 2025. The notice states a 10% charge for each month of delay from 1 April and suspension of the corresponding authorization, licence, entry or registration until payment.

Announces availability of the 2026 annual renewal and market-surveillance maintenance payments from January 2026, with a deadline of 31 March 2026. Late charges follow the cited rules; this notice itself gives no percentage or fee amount.

Historical DNM notice dated 27 May 2024 about unpaid annual authorisation or inscription renewals and market-surveillance maintenance charges. The original expressly includes a medical-device category and cites LEPS Articles 3, 4 and 6. It states that the 31 March 2024 payment period had expired and describes continued payment access, suspensions and a 1 July cancellation statement. This image does not enact a new amount, establish a 2026 deadline or prove current fee rates. The complete operative wording, category labels, contact and printed date are transcribed; the unchanged original retains the QR codes and decorative insignia. Later notices and tariff provisions require separate comparison.

Historical Decree417, one readable native legislative expression only; scanned16-page alias excluded as same instrument. Complete selected device Articles9–14, mixed-product visa Article29(explicit insumos médicos), common powers/contracts Article40 and administrative/execution Articles41–46, issuer/official title, legislative11July2013, presidential23July2013 and Gazette137/Tomo400/25July2013 identity retained. Article46 says eight days after Gazette publication; no derived effective date invented. Entire417 expressly repealed by same-batch846Article10, effective846Article11 on1January2024. Selected old$25 device modifications preserved as historical evidence; same numerical amounts may be set by later instruments, including existing2025tariff, so amount invalidity is not inferred. Article45 limited repeal of373 preserved as source context only, not a claim about unreviewed later law.

DNM Notice 18 confirms that applications concerning regulated imports, expressly including medical devices for human use, continue through the SFCE system at CIEX/BCR for the stated import, export and narcotics units. The notice does not specify a commencement date.

Illustrated import instructions explicitly include medical devices alongside other regulated products. The device-inclusive paragraphs describe importer registration, powers and import submission, with commercial and personal-use branches. The preliminary pharmaceutical establishment table remains only as source context and is not applied to devices. Another illustrated import guide uses different wording. No printed issue or revision date has been established; the nominal amounts, timelines and portal directions require comparison with later instruments.

The first phase moves three medical-device technical-change procedures to the electronic portal from 28 July 2025. Earlier paper applications and related responses continue on paper. Other changes and renewals remained paper submissions at that stage; later notices expand portal coverage.

The second phase moves eight combined or renamed medical-device technical-change procedures to the electronic portal. Applications submitted on paper before 4 September 2025 continue on paper. Other changes and renewals remained paper submissions at that stage.

Explains payment routing for the second phase of medical-device technical changes, covering eight combined or renamed procedure types. Read this payment notice alongside the separate second-phase filing notice.

The third phase moves four medical-device procedures, including registration renewal, to the electronic portal from 17 September 2025. Earlier paper applications and their responses, extensions or suspensions continue on paper. Technical changes outside the announced phases remain paper submissions.

Explains electronic payment routing for the four third-phase technical-change procedures. Paid but unused payment orders issued before 17 September 2025 may be carried forward through the stated new-request, unpaid-order and email-notification steps.

Phase IV filing notice dated 9 October 2025 lists five processes for the electronic window from 14 October, including cancellation of registration. This image does not itself name medical devices; its relevance is assessed with the companion phase IV payment notice, which explicitly names devices but lists only four modifications. No payment requirement for cancellation is added. Earlier submissions continue physically and remaining technical modifications stay at the counter until further notice. This short original is preserved in full. Later implementation and currentness remain unverified.

Phase IV medical-device payment notice dated 9 October 2025 covers four listed modifications from 14 October: indication of use, discontinuation of registered presentations, formula and presentation extension. The original terminology is retained. It explains how previously paid unused orders may be reused while generating a new unpaid order and notifying the stated SRS address. Cancellation appears only in the companion filing notice and is not added to this payment list. No fee amount or whole-notice repeal is inferred; later implementation remains unverified.

Official phase V filing notice dated 8 December 2025 moves changes to a medical-device code or model exclusively to the electronic window from 9 December. Earlier paper applications and their responses or extensions continue on paper. It states that phases I–IV are already available. It does not expressly repeal the earlier notices.

Official phase V payment notice dated 8 December 2025 moves payment orders for changes to a medical-device code or model to the electronic window from 9 December. It explains reuse of previously paid unused orders: generate the new order as part of submission without paying it, then notify the stated SRS address with the required identifiers. It does not change fee amounts or expressly repeal earlier phase notices. Later implementation remains unverified.

Official one-page SRS form for responding to observations on medical-device registration, renewal, post-registration and certificate applications. Retains all four empty selection controls, response and supporting-document fields, responsible-person signature boxes and the printed version 01 identifier.

Announces an updated guide for medical-device technical changes, effective 4 September 2025. The notice is dated 2 September 2025. Its precise relationship to the separately registered guide version remains to be confirmed.

Payment orders for new medical-device registrations and legal changes move to the electronic portal from 1 July 2025. Orders issued from 9 to 30 June are usable only through 30 June; paid but unused orders from before 9 June follow the stated carry-over process.