By Stewart Eisenhart, Emergo Group South Africa’s Department of Health has released new draft regulations for medical devices and IVDs that accompanies proposed rules issued by the government in 2014.
By Stewart Eisenhart, Emergo Group Russian medical device market regulators have eased registration and market entry requirements for low-risk Class I devices, while at the same time formalizing procedures for certain registration amendments and changes to Instructions for Use (IFU).
By Stewart Eisenhart, Emergo Group Although the European Union has a uniform process, CE Marking, in place to allow registration and marketing of medical devices across all member states, distribution of devices requires regional expertise. In this Emergo podcast, we explain how to identify and vet European device distributors. Edgar Kasteel, Senior Manager at Emergo’s […]
By Stewart Eisenhart, Emergo Group The Australian Therapeutic Goods Administration (TGA) has officially ended the three-year transition period for manufacturers of certain joint replacement devices to apply for reclassification of their products from Class IIb to Class III.
By Stewart Eisenhart, Emergo Group The China Food and Drug Administration (CFDA) will begin a new program of unannounced inspections beginning September 1, 2015 for medical device manufacturers registered to market their products in the country.
By Stewart Eisenhart, Emergo Group Emergo consultants in Mexico City have learned additional information regarding COFEPRIS requirements for US FDA-cleared or approved devices undergoing expedited registration in Mexico.
By Stewart Eisenhart, Emergo Group Emergo consultants in Seoul have conducted a thorough analysis of draft Ministry for Food and Drug Safety (MFDS) revisions to South Korean medical device and IVD regulations announced earlier in 2015 to highlight major changes between current and proposed new requirements.
By Stewart Eisenhart, Emergo Group The Medical Device Authority (MDA), Malaysia’s medical device market regulatory agency, has extended its deadline for temporary expedited device registrations to June 30, 2016.
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has finalized plans to exempt some “well understood” Class I and II medical devices from 510(k) premarket notification requirements, according to new guidance from the agency.
By Stewart Eisenhart, Emergo Group New draft guidance from the US Food and Drug Administration seeks comment on how to effectively apply requirements that Unique Device Identification data be applied directly to medical devices intended for reprocessing and reuse. The agency’s guidance points out that its UDI rule, 21 CFR 801.25, explicitly requires directing UDI marking on […]
By Stewart Eisenhart, Emergo Group Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.