Singapore HSA has recently announced possible changes to the guidance documents GN-17 and GN-18. These changes are currently opened for...

The US FDA announced a publication containing modifications made to the list of standards FDA recognizes for use in premarket review (FDA...

Apple worked closely with the Biologics Consulting Group to attain approval for the De Novo request for their new ECG app on the Apple...

Draft on Local Representatives' Obligations In order to ensure the safety and effectiveness of imported medical devices, NMPA has...

For this cyber-security guidance only, FDA introduces the tiers of higher and standard cyber-security risk to aid medical device...

Korea MFDS' entry into the International Medical Device Regulators Forum (IMDRF), together with their intention to harmonize with the...

AHWP: Guidance on labelling for in vitro diagnostic medical devices Australia: Application fee change for export only medical devices...

EU: UDI guidance documents developed by the MDCG to support implementation of MDR EU: Basic guidance issued for manufacturers on...

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

Canada: Changes to evidence requirements for Class II and Class III infusion pumps Canada: Applications for medical device...

Australia - Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2018 Brazil - Questions and Answers: Resolution RDC...

In September 2018, China's National Medical Products Administration (NMPA) released two expanded lists - Medical devices & IVDs that are...

On October 1, 2018, the FDA launched the Special 510(k) Program Pilot, which aims to expand on the types of changes eligible for the...

MDCO has proposed a trial scheme for provisional approvals of Class II/III/IV Medical Devices. A list of criteria has to be fulfilled...

Australia: Specific evidence and documentation, issued by specific overseas regulators and assessment bodies, will be considered by the...

Malaysia: MDA has released a recent announcement on the full enforcement of the need to register medical devices under section 5 of the...

Australia: 2018 fees and charges released by the Therapeutic Goods Administration Australia: Application fee now charged for a Class I...

EU: Manual on borderline and classification issues updated France: Decree on summary of characteristics for Class III/implantable devices...

Canada: Further reductions to MDSAP audit durations have been announced for small companies Canada: Health Canada is adopting the Global...

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