Chile Medical Device Market Country Report

Registering your medical device in Chile requires approval from the Chilean Ministry of Health’s Instituto de Salud Publica de Chile, or ISP. Certification of conformity and quality certification from the ISP are required for market authorization in Chile.

Chile’s medical device regulatory structure is currently being phased in; only a few products such as examination gloves and hypodermic needles currently fall under mandatory controls. The Chilean medical device regulatory system will eventually resemble those in the US, Canada and Europe, and will entail components such as risk-based device classification, quality system requirements and conformity assessments based on ISO standards. Manufacturers currently have the option to voluntarily register their devices before new rules go into effect.

Let Emergo Group assist you in evaluating the Chilean medical device regulatory framework as it applies to your device(s)

Using our worldwide network of consultants, industry contacts and regulatory resources, Emergo Group can provide you with accurate and actionable analysis through our Global Regulatory Overview Report service. Our country report for Chile covers the following issues:

• ISP Regulatory Information
• Product Assessment based on ISP Requirements
• Device Classification
• Authorized Representation requirements for Chile
• Medical Device Registration Requirements
• Labeling Requirements
• Costs and Timeframes
• Regulatory Roadmap for Chile
• Post-market Surveillance Requirements

If you would like to see what these reports include, you can download a sample Regulatory Overview Report.

Please contact us for more information or a free proposal about our Regulatory Overview Report for Chile.