Change Notification and Major Changes under Decreto Exento N° 25, de 2026

1. Key takeaways

Exempt Decree N° 25, de 2026 provides that where a device undergoes changes in its design, manufacture or intended use that affect its quality, safety or performance, the license holder must apply for a new sanitary registration. This is the first principle of change management in Chile. Ordinary changes, by contrast, must be notified to the ISP, which determines whether a new verification is needed. The dividing line between the two tracks is not the size of the modification but its regulatory impact, and that impact must be assessed before the change is implemented, not after.

The GRZAN working tool is a change impact assessment form: every engineering change, supplier change and labeling change is run through the question of whether it must be reported to the ISP. The form exists precisely because the judgment is easy to get wrong under time pressure. Engineering teams under delivery deadlines, or procurement teams switching suppliers for cost reasons, rarely think in regulatory terms unless a mandatory checkpoint forces the question. A one-page form, applied consistently, prevents the most expensive category of change error: the change that goes live in the market before anyone assesses its regulatory status. The judgment must also be documented, because an undocumented correct answer is indistinguishable from a skipped assessment in an audit.

2. Legal basis

The following sources govern change notification and major changes:

• Decree listing devices under the sanitary control system of Article 111 | Decreto Exento N° 25, de 2026 | March 19, 2026 | change clause: where a device undergoes major changes in its design, manufacture or intended use that affect its quality, safety or performance, a new sanitary registration must be applied for.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 25: for repeated imports of the same product, the scope of verification is limited to confirming that the product is the same certified product (unless the inclusion decree requires per-batch verification).
• Same instrument | Article 26 | labeling must state that the product has passed conformity verification and bear the ISP number.
• Same instrument | Article 21 | documentation requirements by category (the depth of documentation after a change is determined by category).
• Sanitary Code of Chile (Código Sanitario) | DFL N° 725, de 1967 | Article 111(a) | control and certification procedures.

3. Expert insights

Insight 1: the test is not how big the change is, but whether it affects quality, safety or performance.

The operative language of the decree is a change that affects (afecte) quality, safety or performance. A seemingly minor material substitution, if it affects biocompatibility or sterilization effectiveness, is a major change. The judgment must rest on a risk assessment, not on engineering intuition. Two changes of identical technical scale can land on opposite sides of the line depending on what they touch, which is exactly why an intuition-based process fails. The assessment form forces the question to be answered on paper, with a documented rationale, before the change is released to production. The form also creates a paper trail showing that the judgment was made deliberately, which is valuable evidence in any later audit.

Insight 2: the three enumerated dimensions of change cover most real situations once expanded in practice.

The decree lists design, manufacture and intended use as the three dimensions. GRZAN expands them into six categories in the assessment form: design; materials and suppliers; manufacturing process and site; sterilization method; intended use and labeling; and software version. The last three are the practical extension of the statutory text: a sterilization change affects safety, a labeling change touches intended use, and a software update alters performance. Mapping real-world changes onto the six categories at intake means nothing slips through because it does not obviously match the statutory wording.

Insight 3: software version iteration is the new difficulty in change management.

Exempt Decree N° 25, de 2026 brings SaMD within scope. Every software release can change function and performance, and the decree contains no exception for software. Companies must therefore establish a mechanism that maps each version to a judgment of whether it constitutes a major change. The discipline that works is to run the assessment at the point where the release is approved, using the same form as hardware changes, so that software and hardware follow one consistent regulatory process rather than parallel habits. Treating software and hardware through one process also prevents the common gap where IT releases bypass regulatory review entirely.

Insight 4: unreported changes become fixed by automatic renewal.

The registration renews automatically every 3 years (see the validity article). If a major change was implemented without a new application, the certificate keeps renewing with an outdated technical state attached, until an inspection or a recall exposes the accumulated discrepancy at once. The longer the interval between the change and its discovery, the larger the correction: more batches on the market, more documentation to reconstruct, and a weaker position in any dispute about when the divergence began. A quarterly reconciliation between the change ledger and the certificate keeps the divergence window short even if something slips.

4. Practical recommendations

1. Build a change impact assessment form and run all six categories through it: design; materials and suppliers; process and site; sterilization method; intended use and labeling; software version.
2. Base the judgment on the risk assessment conclusion, not on engineering intuition; document the conclusion in writing.
3. Software companies should establish a version-change judgment mechanism, running every release through the assessment form.
4. File major changes before implementing them, avoiding a compliance gap created by implementing first and reporting later.
5. Link the change ledger to the registration dossier, so that the registered state and the actual product stay consistent.

5. Verification checklist

• □ A change impact assessment form covering six categories has been established
• □ Change judgments are based on risk assessments and documented in writing
• □ Software version changes are included in the assessment mechanism
• □ Major changes follow the file-before-implement rule
• □ The change ledger is linked to the registration dossier

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Chilean market with end-to-end services covering the local license holder and importer setup, change impact assessment and change filings, and fee and budget planning under the current ISP arancel. Whether you need an assessment-form review, a cost model for your product class, or hands-on filing support through GICONA, our regulatory team is ready to help. Contact us at info@grzanglobal.com.