Chile Medical Device Regulatory Structure: ISP and SEREMI Explained

1. Key takeaways

Medical device regulation in Chile rests on what can be summarized as a two-agency division of labor combined with a three-layer legal structure. The Instituto de Salud Pública (ISP) is responsible for authorizing conformity assessment bodies, issuing certificates, and conducting technical review of registration dossiers. The Secretaría Regional Ministerial de Salud (SEREMI) is responsible for opening enforcement cases and imposing administrative sanctions in the region where a violation occurs. Companies routinely make the mistake of treating the two bodies as if one reported to the other. In reality they operate as two separate tracks with certification power and enforcement power deliberately split apart: registration questions go to the ISP, while inspections, inquiries and fines go to the SEREMI of the relevant region.

On the regulatory side, Chile does not run on a single statute. Instead, three layers stack on top of each other: Article 111 of the Sanitary Code (the law), which supplies the enabling authority; Supreme Decree N° 825 of 1998 (the regulation), which defines scope, definitions and dossier requirements; and category-by-category inclusion decrees (the implementation layer), which decide which products are actually controlled. The third layer is the one most frequently overlooked, yet it is precisely the document that determines whether a specific product must be registered at all. A company that reads only the law and the regulation may wrongly conclude that Chile is a light-touch market with minimal obligations.

2. Legal basis

• Sanitary Code (Código Sanitario) | DFL N° 725, de 1967 | the current text of Article 111 was amended in 2014 | Article 111 letter a): any natural or legal person, under whatever title, that manufactures, imports, sells or distributes controlled devices must carry out quality control and certification at an institution explicitly authorized in sanitary matters by the Instituto de Salud Pública.
• Sanitary Code | DFL N° 725, de 1967 | Article 111 letter b): the ISP authorizes and inspects the institutions that perform the aforementioned control and certification; where no private institutions carry out these tasks, the ISP performs them itself.
• Sanitary Code | DFL N° 725, de 1967 | Article 111 letter e): for violations of this Article, the SEREMI of the region where the violation occurred is responsible for opening the case (sumario sanitario) and imposing sanctions.
• Law amending the Sanitary Code on pharmacies and drug regulation | Ley N° 20.724 | February 14, 2014 | Article 1: replaces Book Four of the Sanitary Code in its entirety, establishing the current text of Article 111.
• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Articles 1 and 3: controlled devices may be manufactured, imported, sold or distributed only after a conformity verification certificate has been obtained.

3. Expert insights

Insight 1: the separation between certification and enforcement dictates two distinct communication strategies.

Letters a) and b) of Article 111 place authorization and verification with the ISP, while letter e) assigns case filing and sanctions to the SEREMI. This is not a matter of internal administrative housekeeping; the two bodies have different trigger points of responsibility. The ISP contact point is the submission dossier and rounds of technical questioning, whereas the SEREMI contact point is warehouses, clinics, trade fair venues and consumer complaints. GRZAN typically requires clients in its projects to keep the records of the two tracks in separately maintained files: version control of technical documentation sits on the ISP side, while distribution and warehousing compliance sits on the SEREMI side.

Insight 2: among the three legal layers, it is the third that decides commercial viability.

The law layer grants regulatory authority and the regulation layer provides classification and dossier requirements, but what actually makes a given product category subject to certification is the category-by-category inclusion decree. The Decreto Exento N° 25, de 2026, published in the Official Gazette on March 19, 2026, added 39 categories in a single action, which is a concentrated exercise of exactly this third layer. Reading only the law and the regulation leads to the mistaken conclusion that Chile is lenient; the inclusion decree is where the real market-access obligations are written.

Insight 3: the internal executing unit within the ISP is ANDID/ANDIM.

Within the ISP, the National Department of Medical Devices, Innovation and Development (ANDID, operating in practice as Departamento ANDIM) is the specific executing department for the Decreto Exento N° 25, de 2026. Technical inquiries submitted to the ISP, technical vigilance reports and change notifications all effectively land in this unit. Knowing the correct internal addressee shortens response times considerably and prevents correspondence from being rerouted between departments.

4. Practical recommendations

1. Maintain a three-layer regulatory ledger: one record for the law layer (Article 111 of the Sanitary Code), one for the regulation layer (DS 825/1998) and one for the inclusion decree layer (the Decreto Exento N° 25, de 2026 and successors), each annotated with publication dates and verification dates, and reviewed quarterly.
2. Keep the two communication tracks in separate files: on the ISP side, record submission numbers, procedure codes and rounds of technical inquiries; on the SEREMI side, record warehouse addresses, inspection findings and the closure status of corrective actions.
3. Address outgoing letters to the correct body: technical inquiries go to the ISP/ANDIM, while corrective actions and explanations concerning distribution go to the SEREMI of the competent region. Misaddressed letters are among the most common sources of wasted, ineffective communication in Latin American projects.
4. Never conclude from a distributor that registration is unnecessary: compare the product against the annex of the inclusion decree itself, remembering that the responsible party remains the manufacturer and the certificate holder regardless of what a distributor claims.

5. Verification checklist

• □ Confirmed the division of responsibilities between the competent authorities for the product: ISP (certification and verification) and SEREMI (inspection and sanctions)
• □ Obtained the current text of Article 111 of the Sanitary Code and checked letters a), b) and e)
• □ Established a three-layer regulatory ledger including decree numbers, publication dates and article numbers
• □ Confirmed the status of the product within the category-by-category inclusion decree lists
• □ Designated separate contact persons for the ISP side and the SEREMI side

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 end-to-end support for ISP registration and compliance in the Chilean market: product-to-list mapping against the inclusion decrees, classification analysis, technical dossier preparation aligned with DS 825/1998, Spanish-language labeling review, and structured correspondence with the ISP and the SEREMI. Reach us at info@grzanglobal.com.