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Companies filing premarket approval applications for in vitro companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, Japan’s Pharmaceuticals and Medical Devices Agency says in recent technical guidance. Read More
Malaysia’s Medical Device Authority has released a 12-step guideline for submitting registration applications for in vitro diagnostic products through the agency’s web-based system. Read More
Manufacturers of in vitro diagnostics and low-risk medical devices could have an easier time registering their products in Brazil, thanks to a pair of resolutions proposed by Anvisa. Read More
Manufacturers of all in vitro diagnostics now have until June 30, 2015, to file an application for inclusion of currently marketed products on the Australia Register of Therapeutic Goods. The original deadline was June 30 of this year. Read More
South Africa is taking another stab at regulating medical devices and in vitro diagnostic products, this time via a regulation that would bring them under the purview of the Medicines Control Council. Read More
Enhancement Medical received a warning letter for failing to document supplier evaluations related to production of the Expression intranasal splint. Read More
The FDA has granted RevMedx’s request to move nonabsorbable expandable hemostatic sponges to Class II, but is requiring special controls to ensure the device is effective when used. Read More
Rumors of a Medtronic/Covidien merger were confirmed last week with the announcement that Medtronic will pay $42.9 billion in cash and stock for the Dublin-based devicemaker. Read More