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.
Emerging Markets
Chinese regulators plan surprise inspections for medical device facilities
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.
Clarification: When COFEPRIS will accept ISO 13485 in lieu of EIRs for US devices seeking expedited Mexico registration
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.
Analysis of new draft regulation for medical devices in South Korea
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.
Malaysia extends deadline for medical device registrations
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.
US FDA finalizes 510(k) exemptions for some Class I and II medical devices
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.
US FDA addresses UDI direct marking for reprocessed devices
By Stewart Eisenhart, Emergo Group New draft guidance from the US Food and Drug Administration seeks comment on how to effectively apply requirements that Unique Device Identification data be applied directly to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 […]
Hong Kong regulators issue list of recognized standards for medical devices
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.
Emergo Podcast: ANVISA medical device approval in Brazil
By Stewart Eisenhart, Emergo Group Brazil’s medical device market offers significant growth potential for foreign manufacturers, but the country’s device approval process is challenging. In this podcast, Emergo Vice President of Business Development Ann Marie Boullie provides an overview of Brazil’s regulatory requirements for medical device registration, including:
New US FDA guidance: Six benefit-risk factors to include in medical device IDE applications
By Stewart Eisenhart, Emergo Group In an effort to boost predictability and transparency of its Investigational Device Exemption (IDE) review process, the US Food and Drug Administration has published new guidance explaining key issues the agency uses to assess benefits and risks of IDE submissions for clinical investigations of Class III and some Class II […]
New medical device barcodes required by Saudi regulators
By Stewart Eisenhart, Emergo Group New rules issued by medical device market regulators in the Kingdom of Saudi Arabia require new barcodes for some types of devices registered for sale in the KSA.
