What's Changed? On 12 June 2026, Brazil's National Health Surveillance Agency (ANVISA) announced additional support measures as the country transitions to the Declaração Única de Importação (DUIMP), Brazil's new Single Import Declaration system. Since 27 April 2026, DUIMP has become mandatory for many import operations requiring ANVISA authorisation, replacing the previous Import Licence (LI) and Import Declaration (DI) processes. The new model centralises customs, fiscal, co

On 20 March 2024, ANVISA published Resolution RDC 850/2024 with an official announcement to extend the Brazil Good Manufacturing...

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

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...

China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...

China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...

On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of...

Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...

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

International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...

US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...