Ley N° 20.724 and the 2014 Rewrite of Chilean Device Regulation

1. Key takeaways

Ley N° 20.724 (published February 14, 2014) is the watershed for understanding Chilean device regulation today. It accomplished three structural things: it replaced Book Four of the Sanitary Code in its entirety, extracting device regulation from the older, scattered provisions; it established the dual-track mechanism of conformity verification plus certification; and it explicitly vested the power of category-by-category activation in reasoned decrees of the Ministerio de Salud. Taken together, these three elements form the legal precondition that allowed the Decreto Exento N° 25, de 2026 to expand the controlled list in a single stroke in 2026.

For companies, the practical meaning is twofold. First, any Chilean document predating 2014 must be treated as textually unreliable until checked against the post-amendment text. Second, because the activation mechanism lives in delegated legislation rather than in the statute itself, the controlled list is inherently dynamic, and monitoring inclusion decrees is a permanent compliance task rather than a one-off exercise.

The date chain also matters operationally: the law was enacted on January 30, 2014 and published on February 14, 2014, and its Article 1 carried out the replacement of Book Four (Libro Cuarto) as a single operation. The downstream instruments — the current Article 111, the pre-market requirement of Article 1 of DS 825/1998, and ultimately the inclusion of 39 categories by the Decreto Exento N° 25, de 2026 on March 19, 2026 — all hang from this amendment. Citing the chain in the correct order, law to regulation to inclusion decree, is the citation discipline that keeps a Chilean compliance file internally consistent.

2. Legal basis

• Law amending the Sanitary Code on pharmacies and drug regulation | Ley N° 20.724 | published February 14, 2014 (enacted January 30, 2014) | Article 1: introduces amendments to the Sanitary Code, replacing Book Four (Libro Cuarto) in its entirety with its new text.
• Sanitary Code | DFL N° 725, de 1967 | current Article 111 | letter a): control and certification must be completed at institutions authorized by the ISP; letter d): implementation category by category through reasoned decrees.
• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 1: the pre-market requirement that operates alongside Article 111.
• Decree including listed devices in the sanitary control regime of Article 111 | Decreto Exento N° 25, de 2026 | March 19, 2026 | includes 39 categories pursuant to Article 111 and DS 825/1998.

3. Expert insights

Insight 1: Book Four was replaced wholesale, not patched.

The legislative technique chosen by Ley N° 20.724 was wholesale replacement rather than article-by-article amendment. This has a concrete practical consequence: many conclusions of experience drawn before 2014 lost their textual footing. When GRZAN reviews a client’s existing Chilean documentation, the first check is whether the cited provisions are the current ones established by the replacement — instructions for use and authorization letters that quote pre-2014 texts are returned directly during deficiency remediation. Compliance files should therefore cite the statute as it stands after the amendment, not as it historically read.

Insight 2: the dual-track mechanism really means the coexistence of verification by authorized bodies and certification by the ISP.

Letter a) of Article 111 requires control and certification to be performed at institutions authorized by the ISP, while letter b) provides that where no private institutions exist, the ISP performs these tasks itself. For the newly included categories there are currently no accredited private conformity verification bodies, so the ISP directly performs the verification role. This is not a temporary arrangement but the normal branch contemplated by letter b), which means companies face a single institution wearing two hats: it is at once the verification body and the registration and certification authority. Submissions are therefore reviewed by the same organization that wrote the framework.

Insight 3: the design of category-by-category activation means expansion requires no statutory amendment.

Letter d) vests activation power in reasoned decrees issued by the Ministerio de Salud on ISP proposal, the classic structure of delegated legislation. This is precisely why in 2026 the controlled categories could move from about 10 to 39 without touching the statute. For companies the inference is direct: the list will keep changing, so the judgment must be built as a mechanism, not as a one-time conclusion. A quarterly comparison routine is the minimum sustainable response.

Read together, the three elements explain the full mechanics of the current system. The replacement of Book Four produced a clean statutory base; the dual-track mechanism defined who actually verifies and certifies; and the delegated activation power set the tempo at which scope expands. A compliance strategy that addresses only one of the three — for example, a dossier strategy that ignores the pace of inclusion decrees — leaves the other exposures unmanaged, which is why GRZAN treats the 2014 amendment not as legal history but as the operating manual of the present regime.

4. Practical recommendations

1. Re-verify citation versions in existing documents: all Chilean submission files, authorization letters and instructions for use formed before 2014 should be rechecked against the text established after the replacement by Ley N° 20.724.
2. Build a citation format across the three layers of law, regulation and inclusion decree, annotating every conclusion with its layer, to avoid mistaking the regulation for the law or the inclusion decree for the regulation.
3. Turn list comparison into a quarterly mechanism: the delegated structure of letter d) means expansion will continue; review the match between your products and the latest inclusion decree every quarter.
4. Plan for the dual role of the ISP: because the ISP both verifies and certifies, the quality of responses to technical questions directly determines registration progress; responses should not be treated as formalistic supplements.

5. Verification checklist

• □ Confirmed the publication date and the method of amendment of Ley N° 20.724 (wholesale replacement of Book Four)
• □ Reviewed whether existing documents cite the provisions in force after 2014
• □ Unified citation format across the site according to the three-layer structure
• □ Established a quarterly mechanism for list comparison
• □ Adjusted internal response workflows to account for the dual role of the ISP

Regulatory information verified as of October 29, 2026.

For a Chile market-entry feasibility assessment covering your specific product, contact the GRZAN regulatory team. GRZAN provides ISP registration and compliance support for the Chilean market, including retrospective document audits against Ley N° 20.724, inclusion-decree monitoring, and dossier preparation aligned with ISP expectations. Reach us at info@grzanglobal.com.