top of page
  • Writer's pictureARQon

Central & South America - April 2017

  • Argentina: Aesthetic use products to be subject to sanitary registration requirements

  • Brazil: Clinical data requirements for innovative and certain high-risk medical devices

  • Brazil: Changes proposed to GCP inspections

  • Brazil: Inmetro further extends compliance date for new conformity assessment procedures

  • Colombia: Draft labelling requirements for IVD and other reagents

Click here for the full article on Global Regulatory Press.

Contact us at info@arq-on.com.


32 views0 comments

Recent Posts

See All

Central and South America - May 2020

Brazil: Resolution RDC No 340 and Normative Instruction 61 cover changes to information both pre- and post-market Brazil: Changes to requirements for syringes and infusion/transfusion pump sets Ecuado

Central & South America - Nov/Dec 2019

Brazil: Requirements finalized for custom-made and patient-specific medical devices Brazil: Proposed changes to requirements for syringes and infusion/transfusion pump sets Ecuador: Technical Regulati

Central & South America - Aug 2019

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: Compu

bottom of page