Chile medical device registration timeline
Source-linked clocksPublic Health Institute of Chile (ISP) review clocks and end-to-end planning ranges, using the 4-class (I, II, III, IV) — D.S. 102/2014 classification system.
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| ISP sanitary registration(ISP registration) ISP service sheet: 60 working days on average, provided no new documents are requested; the service sheet does not allocate separate clocks by risk class | 60 working days | 3-5 months | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesChile Medical Device Registration Process
Step-by-step ISP registration process. Total estimated timeline: 3-5 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by ISP. Appoint a Chilean Legal Representative.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to ISP including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksISP reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
60 working daysIn-depth technical assessment of device safety and performance. ISP may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, ISP issues Chile market authorization certificate.
- Local Authorized Representative (Chilean legal representative)
- Free-sale certificate and legalized documentation from country of origin
- Registration valid for 10 years; renewals follow the same review track
MDSAP: Accepted as QMS evidence