- Jul 30, 2020
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...
- Dec 4, 2019
Central & South America - Nov/Dec 2019
Brazil: Requirements finalized for custom-made and patient-specific medical devices Brazil: Proposed changes to requirements for syringes...
- Aug 30, 2019
Central & South America - Aug 2019
Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices Ecuador: Proposed revision of PRTE INEN No...
- Jun 28, 2019
Central & South America - Jun 2019
Argentina: Procedure for requesting an import authorisation for a medical product Argentina: Regulatory controls established for...
- Mar 29, 2019
Central & South America - Mar 2019
Brazil: Electronic submission of application documentation to replace paper copies Brazil: Proposal for ‘classifying’ medical devices as...
- Nov 5, 2018
Central & South America - Dec 2018
Brazil: Requirements drafted for custom-made and patient-specific medical devices Brazil: Procedure for handling imported medical devices...
- Sep 4, 2018
Central & South America - Aug/Sep 2018
Brazil: Plans to replace cadastro registration with notification system for Class I devices Brazil: Barcodes to be required for coronary...
- May 23, 2018
Central & South America - May 2018
Brazil: Acceptance of third-party audits for Brazilian GMP certification extended to local and Mercosur manufacturers Brazil: New...
- Feb 2, 2018
Central & South America - February 2018
Brazil: Medical device registrations valid for 10 years instead of five years Brazil: Good Manufacturing Practice certification of...
- Jan 1, 2018
Central & South America - December 2017
Brazil: New pathway added for GMP certification of international devices Brazil: Consultation held on extending validity term of...