Chile Medical Device Registration: 20 FAQs on the 2026 Class 39 Expansion and ISP Licensing

On 19 March 2026 the Official Gazette of Chile published Ministry of Health Decreto Exento No. 25/2026, which brings 39 categories of medical devices and in vitro diagnostic products under mandatory sanitary control in a single step. The arrangement Chile has used for almost thirty years – control of a small number of categories, free circulation for everything else – has now formally entered its countdown.

For Chinese manufacturers the real risk is not whether to register, but that the judgement was already made wrongly three years ago: the product was classified into the wrong class, the registration holder was signed over to a distributor, and a CE certificate was treated as a pass.

This article sets out 20 high-frequency questions in Q&A form. Every conclusion maps to the text of Chilean official legislation (the Sanitary Code, Supreme Decree No. 825/1998 and Decreto Exento No. 25/2026), checked against the Ley Chile database of the Library of Congress of Chile, October 2026 version, with an index of the provisions cited at the end.

1. Regulatory framework: establish who regulates, and under what rules

Q1. Which authority regulates medical devices in Chile?

The Institute of Public Health of Chile (ISP, Instituto de Salud Publica de Chile), which sits within the Ministry of Health (MINSAL) system, handles registration intake, technical review, certificate issuance and post-market surveillance for controlled devices; the ISP has a dedicated medical device review department.

Inspection at ports of entry and in the distribution chain, together with sanitary administrative penalties (sumario sanitario), fall to the Regional Ministerial Secretariat of Health (SEREMI) of the region in which the product is located – an explicit division of duties set out in Article 111(e) of the Sanitary Code.

In one sentence: registration goes to the ISP, inspections and fines go to the SEREMI.

Q2. Is Chilean device regulation a single law or a set of laws?

Three layers, all of them necessary:

The key provision is Article 111(d): the control regime applies to a specific product category only where the Ministry of Health implements it by a reasoned decree (decreto fundado). That is the legal root of Chile’s long-standing light-touch regulation, and it is also the legal basis for the 2026 expansion.

Q3. Must every medical device be registered to enter Chile?

No. Chile works on a model of legislative authorisation first and category-by-category inclusion second: only products expressly named in a ministerial decree as subject to mandatory control must obtain an ISP sanitary registration (registro sanitario) before they may be manufactured, imported, sold or distributed. Products outside that list are not currently subject to mandatory registration.

Two reverse risks must nevertheless be kept in mind:

• Article 111(f) of the Sanitary Code and Article 30 of DS 825: products that should be registered but are not are subject to immediate seizure (decomiso);
• Decreto Exento No. 25/2026 has expanded the list from roughly 10 categories to 39, dominated by Class III and IV devices and Class C and D IVDs – the shelf life of the sentence ‘my product is not on the list’ is shortening fast.

How to decide: take the product’s intended use and technical characteristics and compare them item by item against the annex to Decreto Exento No. 25/2026, not against the distributor’s email.

Q4. What exactly did Decreto Exento No. 25/2026 change in 2026? (the most important question in this article)

Decreto Exento No. 25/2026, published on 19 March 2026, brings 39 categories of medical devices and in vitro diagnostic products into the DS 825 framework in one move. Four points:

(1) Scope: mainly Class III and IV devices and Class C and D IVDs, covering imaging and diagnostic equipment, monitoring equipment, therapeutic and life-support equipment (ventilators, haemodialysis machines, extracorporeal circulation equipment, insulin pumps), hospital sterilisation equipment (steam and ethylene oxide), implantable and cardiovascular interventional products (stents, heart valves, hip prostheses, breast implants, intrauterine devices), and medical device software used for oncology image processing, analysis or treatment planning (SaMD).

(2) Timing: 24 months after publication (around March 2028) for implantable and higher-risk products; 36 months (around March 2029) for the remaining products.

(3) Transition: the ISP must publish technical guidance within 12 months (that is, before March 2027) setting out the filing procedure and documentation requirements; until then, companies may apply voluntarily for verification of conformity in advance.

(4) Obligations: once a product is included, it may not be manufactured, imported, sold or distributed without ISP registration; substantial changes affecting quality, safety or performance require a new registration application.

Practical judgement: if the product is on the list, ‘wait until 2029’ is the most expensive strategy available – ISP review capacity and queue risk will be released in a concentrated burst across 2027 and 2028.

Q5. How does Chile classify devices? Can EU or FDA classes simply be carried over?

Article 20 of DS 825 sets four risk classes: Class I (very low risk), Class II (moderate risk), Class III (potentially high risk) and Class IV (most critical risk).

The regulation supplies definitions only, with no classification list attached; the class of a specific product is assigned by the inclusion decree (Article 22). IVDs in Chile are graded A to D (corresponding to I to IV).

No, they cannot simply be carried over. It is not rare for an EU Class IIa product to fall into Class III in Chile. Once the class is wrong, the whole documentation set has to be rebuilt – the most frequent and most expensive source of rework.

2. Pathways and parties: who can hold the certificate matters more than how to file

Q6. Can a foreign manufacturer hold a Chilean registration in its own name?

Not directly as a foreign entity. The ISP intake system identifies applicants by Chilean tax number (RUT), so registration must be filed by a legally established Chilean entity (titular, usually the importer or a local holder company), which then bears the legal responsibilities of the holder under Article 111.

Article 111(I) of the Sanitary Code states expressly that where a defective product causes harm, ‘the holder of the registration or authorisation, the manufacturer and the importer’ are jointly and severally liable to the injured party.

The holder is therefore not a name on paper but the liable party. The holder structure has to be settled in the first round of commercial negotiation, not in the week before filing.

Q7. Can the holder and the importer be separate entities?

Legally they can be designed as different entities, but doing so significantly raises compliance cost and the risk of losing control:

• Each import shipment’s use and disposal (uso y disposicion) requires ISP authorisation (Article 111(g) of the Sanitary Code and Article 27 of DS 825), and the chain of authorisation must be clean;
• The holder must actually hold the technical file and the right to file changes;
• Technical vigilance, recalls and renewal obligations all sit with the local entity.

Recommendation: combine holder and importer, or adopt a binding ‘holder plus exclusive importer’ structure, and write into the agreement the assignment of the registration, handover on termination, ownership of the technical file and duties to cooperate. Channels can be changed; the registration must not slip out of control.

Q8. Letters of authorisation, legalisation and translation: where are the traps?

• Letter of authorisation: requires notarisation plus Apostille. Chile is a party to the Hague Apostille Convention, so public documents are legalised by Apostille with no consular legalisation; documents from non-party states go through consular legalisation.
• Translation: every document not in Spanish must be accompanied by a Spanish translation; labels and instructions must not be translated literally, and the wording of the intended use must match the filing.
• Consistency: the product name, model and manufacturer name in the CFS, the letter of authorisation, the label and the technical file must match word for word – inconsistency is the most common cause of a deficiency letter and usually means re-obtaining documents, four to eight weeks at a time.

3. Technical documentation: not a checklist issue, but a question of evidence level

Q9. What has to be submitted for each class? (the structure of Article 21 of DS 825)

Read this table and it becomes clear why the core of a Class III or Class IV project is not translating the instructions but the clinical evaluation and risk management evidence chain.

Q10. What makes a Certificate of Free Sale (CFS) compliant?

Article 21(a)(6) of DS 825: imported devices must be accompanied by a certificate issued for export purposes by the country of origin, authorised by the competent national authority of that country and duly legalised (debidamente legalizado).

Four elements in practice:

• The issuing body must be the competent authority (NMPA in China, FDA in the United States, the competent authorities in the EU, and so on);
• Legalisation by Apostille or by consular legalisation;
• A Spanish translation enclosed;
• Product information matching word for word (name, model, manufacturer, registration or filing number).

Q11. Does a CE certificate or FDA clearance speed things up, or even replace registration?

It cannot replace registration, and there is no formal reference-country fast track. Chile has no device mutual recognition arrangement with the European Union or the United States; the ISP reviews conformity under Chilean law, not approval granted elsewhere.

CE technical documentation, FDA 510(k) or PMA files and notified body reports can, however, serve as supporting evidence (particularly in the scientific literature and clinical evidence sections for Class III and IV), and can clearly reduce the number of technical query rounds.

Conclusion: treat CE and FDA material as an evidence library, not as a pass.

Q12. What are the requirements for the quality system certificate?

Article 21 of DS 825 requires, by class: NCh-ISO 9002 or GMP for Class II; NCh-ISO 9001 or GMP for Class III and Class IV.

The text remains the 1998 version; in practice the ISP reviews against current technical guidance, and an ISO 13485 certificate is the industry norm. Prepare against four elements: scope covering the filed products, issued by an accredited body, within validity, and legalised by Apostille. Keep GMP conformity evidence as well, so that the certificate scope cannot be challenged as mismatched to the product.

Q13. Is a local clinical trial in Chile required?

Generally not. Article 21 of DS 825 requires the manufacturer’s efficacy and safety studies, studies in a representative patient population (Class IV) and supporting scientific literature (Class III); it does not impose a Chilean clinical trial.

Devices used for research purposes (unregistered products, or uses beyond the registered intended use of a registered product) do, however, require a special temporary use authorisation from the ISP under Article 111(A) of the Sanitary Code, and must comply with Law No. 20,120 on research in human beings and with the liability insurance requirement in Article 111(F).

Note: for Class III and IV, prepare a statement on population applicability in advance (body size, epidemiology, differences in medical practice) – a common query point in Latin American reviews.

Q14. What are the hard requirements for labels and instructions?

Two hard lines:

• Article 26 of DS 825: controlled products must clearly state, on the product itself or on its packaging, that conformity has been verified, together with the number assigned by the ISP; where the nature, composition or volume of the product genuinely prevents this, an ISP resolution is required for an exemption or for an alternative marking method.
• Language: the filed label and instructions for use must be in Spanish (an ISP intake requirement), and the content must be consistent with the filed intended use.

Common mistakes: literal translation of English labels, an over-broad intended use (writing ‘diagnosis’ where the claim is ‘aid to diagnosis’), and a holder name or address on the label that does not match the registration.

4. Timelines, fees and changes: build uncertainty into the plan

Q15. How long does review take?

DS 825 sets no uniform statutory review period for product registration; the actual cycle is driven by the completeness of the file and the number of technical query rounds.

What is certain: Article 7 of the Sanitary Code sets a 30 working day response period for sanitary authorisation procedures (which may be suspended for corrections), and Article 10 of DS 825 sets the same 30 working days for the authorisation of verification bodies. Queuing and technical queries on product registration fall outside both periods.

Planning advice: work backwards from file preparation plus one or two query rounds, and do not treat the registration certificate as a fixed date on the marketing calendar.

Q16. What is the validity of the registration, and how does renewal work?

Under Chilean law the minimum validity of sanitary authorisations is three years, renewable automatically and continuously unless expressly revoked (Article 7 of the Sanitary Code); industry practice is to manage on a three-year cycle with automatic renewal, subject to the ISP decision and current technical guidance.

Management action: renewal is passive, compliance is active. If changes of address, holder, manufacturer name or manufacturing process are not filed, automatic renewal carries the unfiled changes forward as legacy issues – which is fatal in an inspection or a recall.

Q17. How are changes handled?

Two levels:

• Substantial changes: those affecting quality, safety or performance (design, materials, sterilisation method, intended use, manufacturing site) require a new registration application under Decreto Exento No. 25/2026;
• Other changes: must be notified to the ISP, which decides whether new verification is required.

Article 25 of DS 825 also provides that for repeated imports of the same product, verification is limited to confirming that it is the same certified product, unless the inclusion decree requires batch-by-batch verification.

Recommendation: maintain a change impact assessment form, and put every engineering change, supplier change and label change through the question of whether it must be filed with the ISP.

Q18. How is the fee structure calculated?

The statutory principle is clear: the final paragraph of Article 111 of the Sanitary Code provides that certification costs are borne by the applicant. The amount is charged under the ISP’s current fee schedule and depends on the device class and the type of filing (initial, change or renewal).

The real cost sits mainly in three areas: technical file engineering and Spanish localisation, the time needed to obtain the CFS and the Apostille, and compliance costs at the holder, warehousing and import stages. Counting only official fees will always understate total cost.

5. Imports, post-market and liability: the registration is only the entry ticket

Q19. What is needed for customs clearance?

Two gates, both required:

• Customs declaration (destinacion aduanera) under Law No. 18,164;
• Authorisation of use and disposal (uso y disposicion) from the ISP – expressly required by Article 111(g) of the Sanitary Code and Article 27 of DS 825.

In practice this means every shipment needs a customs destination certificate (CDA, Certificado de Destinacion Aduanera) and the ISP use and disposal authorisation; without both, the goods cannot be collected.

The registration is an admission qualification, not a guarantee that each shipment will clear. Port detention charges are usually more expensive than the official registration fee.

Q20. What are the post-market obligations, and how severe are the consequences of non-compliance?

Post-market obligations (Article 28 of DS 825, a two-way reporting duty):

• Healthcare institutions must report to the ISP any defect, malfunction or deterioration in performance, and any missing label or instruction that has caused or could cause death or harm to health;
• The importer or manufacturer must report the technical or medical reasons leading to a systematic recall.

Consequences of non-compliance (three layers):

• Administrative: Article 174 of the Sanitary Code, a fine of 1/10 to 1,000 UTM, doubled for repeat offences; plus closure, revocation of authorisation, suspension of sale or use, recall, seizure and destruction (Articles 174, 175 and 178);
• Product: Article 30 of DS 825, seizure of products sold or distributed without a verification of conformity certificate;
• Civil and criminal: joint and several liability under Article 111(I); Article 111(K) expressly excludes the development risk defence (inadequate scientific knowledge at the time is no excuse), and Article 111(L) sets a five-year limitation period for claims by injured parties.

For the manufacturer, the real loss is not the fine but the channel disruption and the brand damage caused by revocation of the holder’s authorisation.

Conclusion: three judgements decide whether a Chile project succeeds

1. Is the product on the Decreto Exento No. 25/2026 list? (this decides whether to do it at all)

2. Which class is it? (this decides the evidence level and the budget)

3. Who holds the certificate, who imports, and who controls the registration? (this decides whether the certificate is still yours three years from now)

Get any one of these three wrong and everything that follows is sunk cost.

Annex: index of the legislation cited (verified to 26 October 2026)

This article was compiled from the original text of public legislation and does not constitute legal advice. The classification, documentation requirements and transitional treatment of any specific product are subject to the technical guidance issued by the ISP for Decreto Exento No. 25/2026 and to case-by-case decisions; on contractual and liability provisions, an opinion from Chilean local counsel is recommended.