DS 825/1998 Scope and Its Three Exemption Pathways

1. Key takeaways

The scope boundary of Supreme Decree N° 825 of 1998 (DS 825/1998, published August 21, 1999) can be stated in one sentence: controlled devices may not be manufactured, imported, sold or distributed without conformity verification (Articles 1 and 3). At the same time the decree leaves open three exemption channels: provisional sale or use in cases of national emergency or urgent need (Article 4), imports for trade fairs and demonstration purposes (Article 5), and appeals against nonconformity findings (Article 6). The question companies really need to answer is not whether an exemption exists, but whether a given exemption actually covers the specific activity they are about to perform.

2. Legal basis

• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | published August 21, 1999 (enacted November 30, 1998) | Article 1: devices used for the diagnosis, prevention, treatment of human disease or for anatomical replacement or modification, which are not pharmaceuticals, medical foods or cosmetics, may be manufactured, imported, sold or distributed only once they have obtained a certificate attesting conformity with the applicable quality standards.
• Same source | Article 3: any person intending to manufacture, import, sell or distribute the devices listed in Article 1 must first obtain a conformity verification certificate from an institution explicitly authorized in sanitary matters by the Instituto de Salud Pública.
• Same source | Article 4: in a state of national emergency or where the population urgently needs the product, the Director of the ISP may authorize the provisional sale or use of devices governed by this regulation without prior conformity verification.
• Same source | Article 5: the Director of the ISP may authorize the import of devices intended for trade fairs, exhibitions or demonstrations, exempt from conformity verification, provided the products bear a clearly visible marking stating that they may not be sold or put into use before the relevant requirements are met.
• Same source | Article 6: where a device is found nonconforming by an authorized institution, a written appeal may be filed with the ISP within 15 business days from notification of the nonconformity.
• Same source | Article 2 numeral 1: definition of medical device (including software).

3. Expert insights

Insight 1: Article 1 prohibits activities, not product attributes.

The operative point of the provision is the four actions — manufacture, import, sell, distribute — with no quantity threshold and no use-based exemption. A batch of samples, a single demonstration unit, or a one-off charitable donation falls back under the verification requirement of Article 3 as soon as it enters any of the four verbs. GRZAN refers to this in project reviews as the four-verb principle; it is the first filter for judging the compliance of donations and demo units, and it applies before any discussion of exemptions can even begin.

Insight 2: the trade-fair exemption of Article 5 is conditional clearance, not freedom from regulation.

Article 5 requires the product to carry a clearly visible marking stating that it may not be sold or put into use before the requirements are met. This shifts the compliance cost of the exemption onto the marking obligation: if the marking is missing or its wording is unclear, the exemption fails. Whether fair units return home or are later sold raises a separate question of customs disposal, which must be judged independently under the applicable rules.

Insight 3: the discretion over emergency authorization under Article 4 rests with the Director of the ISP personally.

The provision reads that the Director of the ISP may authorize (podrá autorizar), which is discretionary authority rather than an obligation. Companies cannot claim it as a right; they can only advance it as grounds for an application. Any additional technical requirements during a public health emergency, such as clinical and analytical performance requirements for IVDs, are set separately by the competent authority.

Insight 4: the 15 business days of Article 6 are an appeal deadline, not a remediation period.

The clock runs from service of the nonconformity notification, and 15 business days is the window in which a written appeal must reach the ISP; once it lapses, the appeal route is lost. This deadline is shorter than many companies expect — teams often place the internal review first and only then plan the appeal, discovering too late that the window has closed.

4. Practical recommendations

1. Use the four-verb principle as the first compliance screen for samples and donations: whenever manufacture, import, sale or distribution is involved, assume verification is required first, then look for a specific exemption ground.
2. Produce Spanish-language signage for trade-fair units in advance, with wording stating clearly that the product may not be sold or put into use before the relevant requirements are completed, and keep dated photographs on file as evidence.
3. Write the 15 business days of Article 6 into the internal quality-event procedure: start the clock on the day the nonconformity notification arrives, and set the tenth business day as the internal finalization node for the appeal dossier.
4. Prepare two sets of materials for emergency-use applications: a statement of public health necessity plus minimum evidence of product safety, so the Director of the ISP can form a judgment quickly when exercising discretion.

5. Verification checklist

• □ Confirmed the four-verb scope of application under Articles 1 and 3 of DS 825/1998
• □ Produced and filed Spanish-language markings for trade-fair units under Article 5
• □ Confirmed that Article 4 emergency authorization is discretionary and has not been asserted as a right
• □ Incorporated the 15 business days appeal deadline of Article 6 into the quality-event procedure
• □ Checked whether the product falls within the device definition of Article 2 numeral 1 (including software)

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: exemption-pathway analysis under DS 825/1998, trade-fair marking reviews, appeal-dossier preparation within statutory deadlines, and donation and sample compliance screening. Reach us at info@grzanglobal.com.