Chile Medical Device Regulations 2010

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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 verification …

An overview of the medical device regulations in Chile

https://globalregulatorypress.com/issue_articles/an-overview-of-the-medical-device-regulations-in-chile/

Medical devices are currently defined as ‘any instrument, apparatus, application, material or article, including software, used alone or in combination, which are defined by the …

Regulation Of Medical Devices Chile - Healthcare - Chile - Mondaq

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

Chile Medical Device Regulatory Information - Elsmar Cove …

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

Medical Device Regulations in Chile: Other Medical Device Regulations World-Wide: 1: Nov 24, 2016: Biocompatibility requirements for submission to Chile: …

Medtech In Chile: Currently Latin America's Easiest …

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, surgical cameras, electric operating tables, …

Medical devices - Regulation of medical devices in Chile

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

Legal definition of Medical Device. Medical devices (“dispositivos medicos” in Spanish) are instruments, apparatus, applications, materials or articles , including …

Regulatory, Pricing and Reimbursement Overview: Chile

https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-chile/

In Chile, the authorization for the commercialization of a pharmaceutical product is governed by the Sanitary Code, the regulations set forth in Supreme Decree No. 3/2010, issued by the MoH, …

Chile medical device registration process | MDRC

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

Chile medical device registration process | MDRC Chile medical device registration process MDRC assists medical device companies worldwide with registration, representation, …

Medical device regulatory environment: Peru, Chile, …

https://mdrc-consulting.com/latam-medical-device-regulatory-environment/

Medical device regulatory environment: Peru, Chile, Ecuador, Costa Rica, Panama, Colombia, Paraguay, El Salvador, Uruguay, Bolivia | MDRC Medical device regulatory environment: Peru, Chile, Ecuador, …

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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