Regulatory Requirements Medical Devices In Chile

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Chile Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/chile/

In general, it is not required to register medical devices, however, it is recommended that they have a voluntary certification. Appoint an authorized representative (AR) in Chile. Provide information including name of AR and …

An overview of the regulatory requirements …

https://globalregulatorypress.com/product/an-overview-of-the-regulatory-requirements-for-medical-devices-in-chile-february-2019/

An overview of the regulatory requirements for medical devices in Chile. £50.00. The level of medical device regulation is not high in Chile as only five types of medical …

Chile Medical Device Registration - ISP Approval | LICENSALE®

https://arazygroup.com/medical-device-registration-chile/

Medical Device Regulations and Classification in Chile REGULATORY AUTHORITY: Medical devices are regulated by the ISP ( Instituto de Salud Pública or …

Chile medical device registration process | MDRC

https://mdrc-consulting.com/chile-medical-device-registration-process-en/

MDRC assists medical device companies worldwide with registration, representation, quality system compliance and distribution in Chile. Device classification in Chile. …

Regulation Of Medical Devices Chile

https://www.mondaq.com/healthcare/497754/regulation-of-medical-devices-chile

Chile: Regulation Of Medical Devices Chile. 1. Legal definition of Medical Device. Medical devices ("dispositivos medicos" in Spanish) are any instrument, …

Chile Medical Device Regulatory Information - Elsmar Cove …

https://elsmar.com/elsmarqualityforum/threads/chile-medical-device-regulatory-information.64155/

Chile Medical Device Regulatory Information Home Forums Medical Devices, Medical Information Technology, Medical Software and Health Informatics …

Medtech In Chile Currently Latin America’s …

https://www.meddeviceonline.com/doc/medtech-in-chile-currently-latin-america-s-easiest-market-but-for-how-long-0001

Chile classifies medical devices into four classes: 14 Class I (low risk): Examples are cholesterol and uric acid test systems, surgical instruments, bandages, …

Brokering Abogados

https://www.brokering.cl/regulation-of-medical-devices-in-chile/

According to article 3 of Decree 825/98, persons or companies that want at any title, to fabricate, import, commercialize or distribute medical devices need to obtain …

Latin American countries' regulatory …

https://mdrc-consulting.com/south-america-regulatory-processes-en/

In general, medical device regulatory requirements in Mercosur countries and associated countries are similar but not identical. Sometimes regulatory procedures can vary …

Chile - Labeling & Marking Requirements

https://www.trade.gov/country-commercial-guides/chile-labeling-marking-requirements

Chile has common labeling requirements for imported products. Among the most important requirements for U.S. exporters is that labeling must be in Spanish and …

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