Importing Medical Devices Into Chile

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Chile - Import Requirements and Documentation

https://www.trade.gov/country-commercial-guides/chile-import-requirements-and-documentation

Last published date: 2022-09-30. The commercial forms used by both local importers and exporters are commercial invoices, certificates of origin, bills of lading, freight insurance, and packing lists. Special permission, certificates, and approval documents, …

Medtech In Chile Currently Latin America’s ... - Med …

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

The total market size of the medical device sector in Chile is about $1.7 billion and has grown a whopping 75 percent since 2017. American medical …

Chile Medical Device Registration - ISP Approval | LICENSALE®

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

TIMEFRAME: The approval process takes 2-3 months. IVD devices require local testing, which can take up to one year. LICENSE VALIDITY: Licenses issued in Chile are valid …

Change for Importing Medical Devices Into …

https://quickstat.quick.aero/blog/change-for-importing-medical-devices/

Effective July 02, 2018, the import of medical devices into Chile will require a new document from the ISP (Instituto Salud Publica-Public Health Institute.) The …

Chile Medical Device Regulations | RegDesk

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

Premarket Approval Process. In general, it is not required to register medical devices, however, it is recommended that they have a voluntary certification. Appoint an …

Chile - Labeling & Marking Requirements

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

Last published date: 2022-10-01. Chile has common labeling requirements for imported products. Among the most important requirements for U.S. exporters is that …

State of the Medical Device Market in Chile

https://globalhealthintelligence.com/ghi-analysis/state-of-the-medical-device-market-in-chile/

Despite these significant decreases, overall, we expect to see a 4% increase in the value of imported medical devices and equipment into Chile in 2019. 2018 …

Brokering Abogados

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

Import Process. According to the Sanitary Code and Decree 825/98, the regulation of medical devices will be done progressively, via specific Supreme Decrees …

Regulation Of Medical Devices Chile

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

1. Legal definition of Medical Device. Medical devices ("dispositivos medicos" in Spanish) are any instrument, apparatus, application, material or article, …

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

Importing FDA medical device. Medical device classification, pre-market submission, medical device registration and listing, 510(k), PMA, medical device labeling

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