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

Brazil: Requirements finalized for custom-made and patient-specific medical devices Brazil: Proposed changes to requirements for syringes...

Brazil: Parametric release may replace sterility test for ethylene oxide sterilised devices Ecuador: Proposed revision of PRTE INEN No...

Argentina: Procedure for requesting an import authorisation for a medical product Argentina: Regulatory controls established for...

Brazil: Electronic submission of application documentation to replace paper copies Brazil: Proposal for ‘classifying’ medical devices as...

Brazil: Requirements drafted for custom-made and patient-specific medical devices Brazil: Procedure for handling imported medical devices...

Brazil: Plans to replace cadastro registration with notification system for Class I devices Brazil: Barcodes to be required for coronary...

Brazil: Acceptance of third-party audits for Brazilian GMP certification extended to local and Mercosur manufacturers Brazil: New...

Brazil: Medical device registrations valid for 10 years instead of five years Brazil: Good Manufacturing Practice certification of...

Brazil: New pathway added for GMP certification of international devices Brazil: Consultation held on extending validity term of...

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...

Brazil: Medical device and IVD fee reductions formally take effect Brazil: Appeal timeframes extended by ANVISA Brazil: Mercury to be...

Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...

Knowledge of response times, requirements that must be met, trademarks and samples is crucial for obtaining sanitary registration of...

Argentina: Aesthetic use products to be subject to sanitary registration requirements Brazil: Clinical data requirements for innovative...