paesi america cile

Chile

Chile is one of the most developed medical device markets in South America, with an advanced healthcare system and a strong openness to imports.

Do you require help or further information?
Contact us! We are happy to advise you:
…
+39 0542 683803
law 4617873 1920

Regulatory Framework

The competent authority is the Instituto de Salud Pública de Chile (ISPCH).

Device Classification:

  • Class I: Low risk
  • Class II: Moderate risk
  • Class III: High risk
  • Class IV: Very high risk
office 3199659 1920

Specific Local Requirements

Language Documentation in Spanish.
Local Representative Required for foreign manufacturers.
Certifications Certificate of Free Sale, CE, FDA, and ISO 13485 facilitate the process.

Challenges and Operational Advice

  • Variable review times: Dependent on device complexity.
  • Regulations under revision: Registration requirements may change.
Business adviser analyzing financial figures denoting the progress in the work of the company

Why Choose ISEMED

  • Latin America Expertise
    Qualified support for the Chilean market.
  • Comprehensive Assistance
    From dossier preparation to registration.
FAQ question 6387294 1920

FAQ

  • Is a local representative required? Yes.
  • Documentation language? Spanish.
  • License duration? 5 years.
We Value Your Privacy
We use cookies on our website. Some of them are essential, while others help us to analyze how this website is being used and to allow you to contact us through our website, i.e. use the chat widget. You can change your decision at any time.
We Value Your Privacy
Statistics
We use these technologies to analyze how this website is being used.
Name Google Analytics, Google Tag Manager
Provider Google Ireland Limited, Gordon House, Barrow Street, Dublin 4, Ireland
Purpose Cookie by Google used for website analytics. Generates statistical data on how the visitor uses the website.
Privacy Policy https://policies.google.com/privacy
Cookie Name _ga, _gat, _gid
Cookie Expiry 2 years
Name Salesforce Marketing Cloud Account Engagement
Provider Salesforce, Inc. Salesforce Tower, 415 Mission Street, 3rd Floor, San Francisco, CA 94105, United States
Purpose Tracks visitor and prospect activities on our website pages by setting cookies on the browser.
Privacy Policy Link
Cookie Name visitor_id1109552, pi_opt_in1109552, visitor_id1109552-hash, lpv1109552, pardot
Cookie Expiry 2 years
Customer Interaction
These technologies will allow you to contact us through our website, i.e. use the chat widget.
Name LiveChat
Provider LiveChat Software S.A., ul. Zwycięska 47, 53-033 Wroclaw, Poland
Purpose Communication with clients via online chat using the API of the chat service LiveChat.
Privacy Policy https://www.livechat.com/legal/privacy-policy/
Cookie Name __lc_cid, __lc_cst
Cookie Expiry 2 years
Essential
Technologies required to enable the core functionality of this website.
Name Cookie Consent
Provider Owner of this website, Imprint
Purpose Saves the visitors preferences selected in the cookie banner.
Cookie Name ws_cookie_consent
Cookie Expiry 1 year
Privacy Policy