South America Medical Device Regulations

Latin American countries' regulatory approval …

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

Regulatory requirements of the biggest Latin American markets are largely harmonized under the South American trade bloc Mercosur comprising Argentina, Brazil, Paraguay, Uruguay as well as associated countries such as Bolivia, Chile, Colombia, Ecuador, Guyana, Peru and Suriname. The largest medical devices Mercosur markets are Brazil and Argentina.

Regulatory Affairs in Latin America for Medical Devices

https://informaconnect.com/regulatory-affairs-in-latin-america-for-medical-devices/

Guided by trainers with a background of working for COFEPRIS, delegates will journey from country to country in the region and explore the key issues in Latin America from dossier …

Latin American Medical Device Regulations

https://www.mddionline.com/regulatory-quality/latin-american-medical-device-regulations

The National Institute of Hygiene and Tropical Medicine is responsible for the regulation of medical …

Peru - Medical Devices - International Trade Administration

https://www.trade.gov/country-commercial-guides/peru-medical-devices

South America | RegDesk | Medical Device Regulations

https://www.regdesk.co/category/south-america/

South America Argentina Updates Medical Device Registration Rules. The National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina’s …

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

Only four types of medical devices are subject to mandatory registration with Chile's National Drug Agency (ANAMED in Spanish), a dependency of the …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Investigational Device Exemption (IDE) - 21CFR Part 812 An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in …

Medical Devices - SAHPRA

https://www.sahpra.org.za/medical-devices/

Licensing of Medical Device Establishments. An applicant may apply for one of three types of licences for medical device establishments: …

Malaysia - Medical Devices Regulations

https://www.artixio.com/post/malaysia-medical-devices-regulations

Medical Devices in Malaysia re regulated by Malaysian Medical Device Authority (MDA). The Medical Devices need to be registered in Malaysia before they …

HSA | Regulatory overview of medical devices

https://www.hsa.gov.sg/medical-devices/regulatory-overview

All medical devices will require registration with us before they can be supplied in Singapore, except for Class A low risk medical devices, which are exempted from …