Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
ISP
Register your medical device in Chile.
Complete electronic health registration through GICONA, with gradual implementation over 24 months for implants and Class IV devices.
Speak to a specialistThe authority
Instituto de Salud Publica de Chile
ISP
Regulatory authority
Chile
An autonomous public service under the Ministry of Health responsible for regulating medicines, food and medical devices in Chile.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk | Bandages, masks, gauze |
| Class II | Moderate risk | Infusion pumps, diagnostic equipment |
| Class III | High risk | Non-active implants, advanced surgical equipment |
| Class IV | Critical risk (implants and high-risk devices) | Pacemakers, valves, haemodialysis |
Registration process
How we manage your project
- 01
Local Representative2-3 months
Establish a Chilean Registration Holder
- 02
Classification2 weeks
Determine the class under Decreto No. 825
- 03
ISO 13485 QMS3-6 months
Mandatory certified quality management system
- 04
Technical dossier2-3 months
Prepare the electronic submission through GICONA in Spanish
- 05
GICONA submission4-8 months
The ISP electronic platform assesses the dossier
- 06
Certificate issuance1-2 weeks
Electronic Health Registration issued
Total timeframeGradual implementation over 24 months for Class IV (implants and high-risk devices)
Local representativeChilean Registration Holder
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | ISP technovigilance and adverse event reporting |
| Renewal | 5 years, renewable |
| Required QMS | ISO 13485 (mandatory) |
How HSC helps
Chile through electronic GICONA registration with substantial equivalence.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about ISP
Next step
Ready to start your project in Chile?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist