Do You Need Local Clinical Trials in Chile? Registration vs Research Use

1. Key takeaways

Routine sanitary registration generally does not require local clinical trials in Chile. Article 21 of DS 825/1998 calls for the manufacturer’s effectiveness and safety studies, studies in representative patient populations for Class IV devices, and supporting scientific literature for Class III devices — and all of these can be foreign data and literature.

One independent pathway, however, must be clearly separated: research-use devices (unregistered products, or registered products used beyond the scope of their registration) must obtain the ISP’s special authorization for temporary use under the Sanitary Code and comply with Law No. 20.120 (research on humans) and its implementing regulation. This is a separate compliance procedure running outside registration, with its own authorizations, its own ethics gate and its own timeline, and the two tracks must be planned as parallel projects rather than mixed into one. Companies that conflate them either over-invest in trials they never needed or under-invest in the ethics process their research actually requires.

2. Legal basis

• Regulation on the control of medical products and devices | Decreto Supremo N° 825, de 1998 | 21 August 1999 | Article 21: Class III requires supporting scientific literature together with the manufacturer’s effectiveness and safety studies; Class IV additionally requires studies in representative patient populations, research on the device’s inherent risks, and the manufacturer’s biological studies.
• Same instrument | Article 4 | in a state of national emergency or urgent population need, the ISP Director may authorize temporary sale or use of devices without prior conformity verification.
• Same instrument | Article 5 | devices imported for fairs, exhibitions or demonstrations may be exempted from conformity verification, provided they carry clear markings stating that they may not be sold or put into use before the requirements are completed.
• Law on scientific research on humans | Ley N° 20.120 | 2006 | the regulatory framework for research on humans, genomics and the prohibition of cloning.
• Implementing regulation of the law on scientific research on humans | Decreto Supremo N° 114, de 2010 | published in the Official Gazette on 19 November 2011 | review by scientific ethics committees and requirements for conducting research.

3. Expert insights

Insight 1: the studies required by Article 21 are evidence — not trials conducted in Chile.

The provision speaks of the manufacturer’s effectiveness and safety studies, support from scientific literature and studies in representative patient populations. These are requirements about the form of evidence, and the statute does not restrict their geographic origin. Reading studies as a mandate to run clinical work inside Chile is an over-interpretation that inflates budgets and timelines substantially. The correct reading: gather the strongest foreign evidence available and defend its applicability. Budgeting a Chilean trial for a routine registration also distorts the business case in the other direction — it can push a commercially sound product out of the market plan entirely.

Insight 2: the representative patient population study for Class IV is the item most often queried.

It is the additional requirement distinguishing Class IV from Class III. GRZAN prepares a population applicability justification: body size, epidemiological characteristics, and differences in local medical practice. This is a frequent query point in Latin American reviews and the key argument for whether foreign data are accepted. A short, well-referenced applicability section attached to the study evidence resolves it before the question is asked. The justification should cite the characteristics of the study population directly, so the reviewer can compare them against the Chilean context without reconstructing the data.

Insight 3: research-use devices run on a separate road — do not mix them up with registration.

Article 4 of DS 825/1998 (temporary sale or use in emergencies or urgent need) and Article 5 (exhibition and demonstration units) are special channels outside registration; genuine clinical research additionally requires the ethics review requirements of Ley N° 20.120 and its implementing regulation DS 114/2010 (scientific ethics committees). The two procedures run in parallel, and both are mandatory — an authorization from one does not substitute the other, and gaps in either stall the project at a different desk.

Insight 4: ethics review is an independent compliance gate.

Under the Law No. 20.120 framework, ethics review is decided by the scientific ethics committee (Comité Ético Científico) and is a different kind of review from the ISP’s technical assessment. Obtaining the ISP’s technical authorization does not mean the research may start. Conversely, ethics approval says nothing about device market access. Treat the two gates as separate approvals with separate document sets and separate lead times. Scheduling them sequentially — ethics first, then technical, or the reverse — doubles the elapsed time; running them in parallel with synchronized submission packs is the only efficient arrangement.

4. Practical recommendations

1. Prepare routine registrations on the model of foreign evidence plus a population applicability justification, and do not budget local clinical trials for routine submissions.
2. For Class IV products, focus on the representative patient population study: demonstrate the comparability of the study population with the Chilean population.
3. Set up research-use devices as separate projects: run the ISP special authorization and the ethics committee review in parallel, managing two timelines.
4. Route exhibition demonstration units through Article 5: produce Spanish markings stating clearly that sale or use is prohibited before the requirements are completed.
5. Prepare both necessity and safety materials for emergency-use applications, so the ISP Director can exercise discretion on a complete record.

5. Verification checklist

• □ It has been confirmed that routine registration does not mandate local clinical trials in Chile
• □ Effectiveness and safety studies and scientific literature evidence have been prepared under Article 21
• □ A representative patient population study and population applicability justification have been prepared for Class IV
• □ Research-use devices have been set up as separate projects, with ISP authorization and ethics review advancing in parallel
• □ Exhibition units carry the Article 5 markings in Spanish

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Chilean market with ISP registration pathways and classification strategy, including evidence planning under Article 21 and the ethics pathway for research-use devices. For a feasibility assessment of your specific product, contact the GRZAN regulatory team at info@grzanglobal.com.