Central & South America - Nov 2020

• Brazil: Market access process is simplified for Class II devices

• Brazil: Changes to conformity assessment requirements for certain single use devices

• Brazil: Certified translations of documents waived

• Brazil: Uploading Instructions for Use to ANVISA portal becomes mandatory

• Brazil: New guide on cybersecurity is released by ANVISA

• El Salvador: Technical Regulation published to set requirements for medical use face masks

• Peru: Technical document on exceptional health authorisation of medical devices in the research stage

• Peru: Validation guidelines for IVDs under clinical investigation in the context of the COVID-19 pandemic

Click here for the full article on Global Regulatory Press.

Contact us info@arqon.com