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...
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ARQon
Dec 4, 20191 min read
Central & South America - Nov/Dec 2019
Brazil: Requirements finalized for custom-made and patient-specific medical devices Brazil: Proposed changes to requirements for syringes...
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ARQon
Aug 30, 20191 min read
Central & South America - Aug 2019
Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices Ecuador: Proposed revision of PRTE INEN No...
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ARQon
Jun 28, 20191 min read
Central & South America - Jun 2019
Argentina: Procedure for requesting an import authorisation for a medical product Argentina: Regulatory controls established for...
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ARQon
Mar 29, 20191 min read
Central & South America - Mar 2019
Brazil: Electronic submission of application documentation to replace paper copies Brazil: Proposal for ‘classifying’ medical devices as...
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ARQon
Nov 5, 20181 min read
Central & South America - Dec 2018
Brazil: Requirements drafted for custom-made and patient-specific medical devices Brazil: Procedure for handling imported medical devices...
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ARQon
Sep 4, 20181 min read
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...
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ARQon
May 23, 20181 min read
Central & South America - May 2018
Brazil: Acceptance of third-party audits for Brazilian GMP certification extended to local and Mercosur manufacturers Brazil: New...
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ARQon
Feb 2, 20181 min read
Central & South America - February 2018
Brazil: Medical device registrations valid for 10 years instead of five years Brazil: Good Manufacturing Practice certification of...
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ARQon
Jan 1, 20181 min read
Central & South America - December 2017
Brazil: New pathway added for GMP certification of international devices Brazil: Consultation held on extending validity term of...
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ARQon
Sep 1, 20172 min read
Drugs - August 2017
US: FDA and Beyond – REMS 1.16 Subheading Instructions for eCTD M1 v2.3 (DTD 3.3) US: Manual of Policies and Procedures(MAPP) 6021.1...
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ARQon
Aug 24, 20171 min read
Central & South America - May 2017
Brazil: Medical device and IVD fee reductions formally take effect Brazil: Appeal timeframes extended by ANVISA Brazil: Mercury to be...
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ARQon
Aug 24, 20172 min read
Drugs - May 2017
Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...
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ARQon
Apr 7, 20171 min read
Addressing the challenges of medical device registration in the Dominican Republic – requirements, t
Knowledge of response times, requirements that must be met, trademarks and samples is crucial for obtaining sanitary registration of...
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ARQon
Apr 3, 20171 min read
Central & South America - April 2017
Argentina: Aesthetic use products to be subject to sanitary registration requirements Brazil: Clinical data requirements for innovative...
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