Central & South America - Aug 2019

Aug 30, 20191 min read

Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices
Ecuador: Proposed revision of PRTE INEN No 186 concerning electromedical equipment and systems
Mexico: Compulsory standard drafted on Good Manufacturing Practices
Peru: Format for notifications concerning suspected adverse incidents

Click here for the full article on Global Regulatory Press.

Recent Posts

Brazil: Resolution RDC No 340 and Normative Instruction 61 cover changes to information both pre- and post-market Brazil: Changes to...

RDC 232/2018 - Unique Device Identification (UDI) UDI will be enforced on 15 June 2020 that require product label with traceability using...