Article 111 of the Chilean Sanitary Code Explained

1. Key takeaways

Article 111 of the Sanitary Code is the master switch of Chilean device regulation. Its current text was established by Ley N° 20.724, published on February 14, 2014, and consists of seven letters, a) through g), plus a fee clause in the final paragraph. GRZAN compresses it into two actionable sentences for companies: all four activities — manufacturing, importing, selling and distributing — fall within scope (letter a); and goods without a certificate are subject to seizure, with fees borne by the applicant (letter f and the final paragraph). The five letters in between — b), c), d), e) and g) — respectively resolve who verifies, against which standards verification proceeds, how control is activated category by category, who sanctions violations, and how customs clearance is handled.

2. Legal basis

• Sanitary Code (Código Sanitario) | DFL N° 725, de 1967 | current text of Article 111 amended by Ley N° 20.724 (February 14, 2014) | Article 111 letter a): manufacturing, importing, selling and distributing require quality control and certification completed at an institution authorized by the ISP; the regulation is to set out the conditions for institutions and the procedure for applying for authorization; applicants whose request is denied or unanswered within the deadline of the second paragraph of Article 7 may appeal to the Minister of Health.
• Same source | Article 111 letter b): the ISP authorizes and inspects control and certification institutions; where no private institution exists, the ISP performs the tasks itself.
• Same source | Article 111 letter c): control and quality testing follow the Chilean official standards approved by the Ministerio de Salud based on proposals of the Chilean national standardization body (INN); absent such standards, standards approved by the Ministry based on ISP proposals and on information from international organizations or foreign specialized bodies apply. Against a nonconformity finding an appeal lies to the Director of the ISP, and the appealed institution must respond within 10 business days.
• Same source | Article 111 letter d): the application of this Article to each category of device is implemented category by category by the Ministerio de Salud through a reasoned decree (decreto fundado) based on ISP proposals; the decree must list the technical specifications on which control is based and the institutions officially authorized to perform the control, or state that no institution has applied for that authorization.
• Same source | Article 111 letter e): the SEREMI of the region where the violation occurred opens the case and imposes sanctions.
• Same source | Article 111 letter f): devices sold or distributed without the quality certificate required by this Article are subject to seizure (decomiso), without prejudice to other measures the sanitary authority may take.
• Same source | Article 111 letter g): customs disposal of such devices follows Ley N° 18.164, and their use and disposal require ISP authorization.
• Same source | Final paragraph of Article 111: certification fees are borne by the natural or legal person who submits the application.

3. Expert insights

Insight 1: letter a) covers four activities, with no exception for purely domestic sales.

The four verbs — manufacture, import, commercialize, distribute — stand side by side in the text, which means local assembly in Chile, cross-border direct shipping and free samples can all fall within the scope of control. A frequent misunderstanding runs along the lines of a company stating that it does not engage in distribution because it only supplies hospitals; under the wording of Article 111, such supply still falls within the reach of the verbs comercializar or distribuir. The scope test is activity-based, not business-model-based.

Insight 2: letter c) establishes an evidentiary order in which Chilean standards come first.

Quality control applies first to the INN Chilean official standards (NCh), and only in their absence to standards approved by the Ministerio de Salud on ISP proposal, which must rest on information from international organizations or foreign specialized bodies. This provision directly explains why the Decreto Exento N° 25, de 2026 names NCh-ISO 16142-1/2, NCh-ISO 13485 and NCh-ISO 14971: they are the concrete instantiation of the standard hierarchy in letter c). Dossiers that acknowledge this order in advance face fewer rounds of technical questioning.

Insight 3: letter d) is both the legal root of Chile’s historically light control regime and the legal basis for its expansion.

The control regime does not apply automatically to all devices; it must be activated category by category through a reasoned decree of the Ministerio de Salud. This explains why, for more than two decades, only about 10 categories of devices were controlled, and it also explains why in 2026 a single exempt decree could add 39 categories at once: the legislator did not need to amend the statute, only to issue another reasoned decree. The same mechanism can be used again.

Insight 4: seizure under letter f) does not require proof of harm.

Sale or distribution without a certificate triggers seizure as a conduct-based offense rather than a result-based one. This bites harder than a fine: goods can be removed from a warehouse, from customs, or from a distributor’s shelf, and the seizure operates without prejudice to separate sanctions. The practical message is that uncertified inventory is a live asset risk at every point in the chain.

4. Practical recommendations

1. Turn Article 111 into a one-page mapping table with the seven letters assigned to seven internal owner roles: a) submission, b) evidence, c) standards, d) list comparison, e) inspection response, f) inventory risk, g) customs clearance.
2. Write the letter c) evidentiary order into the technical file index: list the NCh standards first, then the international standards, with a sentence explaining why the latter may serve as substitutes when the former are absent. This single sentence measurably reduces rounds of technical questioning.
3. Move letter f) risk forward into commercial terms: include a clause in distribution agreements that no goods may be placed on the market before the sanitary registration certificate is obtained, and allocate the losses from any seizure between the parties.
4. Put the fee clause into the budget: certification fees being borne by the applicant is a statutory principle, and the applicant is usually the Chilean certificate holder; how the cost is ultimately shared must be spelled out in the agreement between the manufacturer and the holder.

5. Verification checklist

• □ Obtained the current text of Article 111 and checked letters a) to g) and the final fee clause item by item
• □ Established a Chilean-standards-first evidentiary order explanation under letter c)
• □ Compared the product category against existing inclusion decrees under letter d)
• □ Included a clause allocating letter f) seizure risk in the distribution agreement
• □ Confirmed the party bearing the certification fees and the cost-sharing arrangement

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 supports manufacturers and certificate holders with ISP registration and compliance in Chile: statutory text tracking, dossier preparation against DS 825/1998, standards-gap analysis, and risk clauses for distribution agreements. Reach us at info@grzanglobal.com.