Chile Existing Controlled Device List Before 2026

1. Key takeaways

Before the Decreto Exento N° 25, de 2026, the categories of devices subject to mandatory sanitary control in Chile had long remained at about 10, implemented mainly through five inclusion decrees: Supreme Decree N° 342 of 2004 (examination gloves, surgical gloves, natural latex male condoms), Supreme Decree N° 1887 of 2007 (single-use sterile hypodermic needles and syringes), Decreto Exento N° 93 of 2018 (condoms made of synthetic materials and female condoms), Supreme Decree N° 42 of 2021 (portable automated external defibrillators), and Decreto Exento N° 41 of 2022 (HIV in vitro diagnostic reagents), together with categories such as immunohematology reagents.

GRZAN notes: the operating paradigm for these ten categories is the operating paradigm for the 39 newly included products. Walking the existing road once is the least expensive way to understand the new rules, because the file structures, evidence expectations and review habits of the ISP were all formed on these earlier categories.

It is also worth noting what the existing list does not contain. Before 2026 there were no imaging systems, no implants, no infusion pumps and no active therapy equipment on the Chilean controlled list; the ten categories were deliberately narrow. That narrowness shaped the regulator as much as it shaped the market: the ISP built its verification practice on simple, standards-based products, which is precisely why the document-review paradigm works, and why applicants for the new categories can still anchor their files in the expectations formed by these earlier decrees.

2. Legal basis

• Inclusion decree for gloves and condoms | Decreto Supremo N° 342, de 2004 | 2004 | brought male condoms, medical examination gloves and surgical gloves under mandatory sanitary control.
• Inclusion decree for sterile hypodermic needles and syringes | Decreto Supremo N° 1887, de 2007 | 2007 | brought single-use sterile hypodermic needles and syringes under control.
• Inclusion decree for synthetic material and female condoms | Decreto Exento N° 93, de 2018 | 2018 | brought male condoms made of synthetic materials and female condoms under control.
• Inclusion decree for portable automated external defibrillators | Decreto Supremo N° 42, de 2021 | 2021 | brought portable AEDs under control.
• Inclusion decree for HIV in vitro diagnostic reagents | Decreto Exento N° 41, de 2022 | 2022 | confirmed that conformity verification is conducted through document review and that evidence from foreign sources may be accepted.
• Sanitary Code | DFL N° 725, de 1967 | Article 111 letter d) | implementation category by category through reasoned decrees.

3. Expert insights

Insight 1: the existing list combines low technical barriers with high public health relevance.

Gloves, condoms, needles and syringes share low unit prices, high volumes, and strong relevance to infection control and public health programs. This contrasts with the 2026 expansion’s focus on high-risk equipment and critical clinical technologies: Chile first ran the process through low-barrier categories and then advanced toward high-risk products, a clear path of regulatory capacity building. The implication for manufacturers is that review expectations will keep rising as the regulator gains experience.

Insight 2: Decreto Supremo N° 42 of 2021 (AED) was the first trial of active equipment.

The portable automated external defibrillator involves electrical safety and the effectiveness of defibrillation waveforms, making it the most technically complex category on the existing list. GRZAN considers that the AED submission experience — the IEC 60601 series, clinical effectiveness evidence, post-market vigilance — directly forms the technical reference for the active devices newly added in 2026, and files built on that reference align with what the ISP has already learned to review.

Insight 3: Decreto Exento N° 41 of 2022 (HIV reagents) established the verification paradigm of document review plus foreign evidence.

That decree confirmed that verification is conducted through document review and that evidence of foreign origin may be accepted. This path was carried forward and scaled to 39 categories by the Decreto Exento N° 25, de 2026, which means the overwhelming majority of submissions do not require local testing in Chile — a decisive cost factor for foreign manufacturers planning their evidence generation strategy.

Insight 4: the naming convention itself carries information.

The difference between a Decreto Supremo and a Decreto Exento lies in the signing and exemption formalities of Chilean administrative procedure, but for a submitter they carry the same rank of effect: both are reasoned decrees within the meaning of letter d) of Article 111. When reading the lists there is no need to agonize over the naming; go directly to the items and classes in the annex.

Finally, the chronology of the five decrees is itself a planning signal. The sequence ran from 2004 to 2007, then 2018, 2021 and 2022, with the intervals shortening over time; the 2026 decree added 39 categories at once. The trajectory suggests that list maintenance is now an active regulatory function rather than a rare legislative event, which is the strongest argument yet for the quarterly review mechanism recommended throughout this guide.

4. Practical recommendations

1. Use approved submissions from the existing ten categories as a template library: the AED and HIV reagent files in particular are ready-made references for active equipment and for IVDs respectively.
2. Prepare new submissions following the annex structure of the existing list: the triad of item description, class annotation and technical specifications has shown continuity across the decrees.
3. Confirm standard versions early: versions of ISO/IEC standards cited in existing submissions must be checked against the versions named in the Decreto Exento N° 25, de 2026; outdated versions are a common cause of deficiency letters.
4. Remember that pre-existing categories sit outside the transition arrangements: products already on the list remain under the current requirements and should not be scheduled against the new transition periods.

5. Verification checklist

• □ Listed the previous inclusion decrees (342/2004, 1887/2007, 93/2018, 42/2021, 41/2022) and the items they cover
• □ Obtained the AED and HIV reagent submission templates and checked their structure
• □ Checked cited standard versions against the versions named in the Decreto Exento N° 25, de 2026
• □ Confirmed whether the product belongs to a pre-existing category or a newly included category
• □ Determined production planning according to the corresponding status (pre-existing categories do not use the new transition periods)

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: template reconstruction from approved files, standard-version alignment, evidence strategy for document-review verification, and status checks against the pre-existing controlled categories. Reach us at info@grzanglobal.com.