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MULTIPLE MARKETS
Medical Device Registration in Australia & New Zealand
Thinking about selling your medical device or IVD in Australia or New Zealand? If your device already has CE Marking or approvals in other key
MULTIPLE MARKETS
Transitioning to Medical Device Single Audit Program (MDSAP) Compliance
As the first year of its operational phase ends, the Medical Device Single Audit Program (MDSAP) is finally gaining traction among medical device
Brazil
Medical device registration process in Brazil
Interested in selling your medical device in Brazil? Brazil's device registration process is well established, but rather complex. It's important to
Brazil
Brazil QMS Requirements For Medical Device Manufacturers
Thinking about selling your medical device in Brazil? If so, you should know that the Brazilian medical device and IVD market is complex. The
Brazil
Overview of the IVD regulatory landscape in Brazil
Want to sell your IVD in Brazil? Brazil regulators made sweeping regulatory changes in 2015, especially for IVDs. In particular, they consolidated
Canada
Preparing a Canadian MDL Application
So you have one or more cleared medical devices in the US and now you want to license them in Canada. While the Canadian registration system seems
Canada
Achieving QMS compliance in Canada for medical device and IVD companies
This white paper will discuss the requirements for achieving compliance with the Quality Management System (QMS) regulations as they apply in Canada
China
China NMPA Medical Device Registration Requirements
Thinking of selling your medical device in China? If so, you need to register your device with China's regulatory authority, the China Food and Drug
Europe
PMS & PSUR requirements under the EU MDR
Medical device post-market surveillance (PMS) activities have already been described in the European Medical Device Directive (93/42/EEC) and are
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