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    ANVISA Extends Deadline for Technical Requirement Responses in Brazil

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Brazilian medical device market regulator ANVISA has officially extended deadlines for market applicants to respond to technical inquiries regarding their registration submissions. ANVISA’s technical requirement response deadline, previously 90 days, has been extended to 120 days from confirmation of requirement receipt by applicants. The...
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    US FDA Proposes Changes to MedWatch Program for Healthcare Products

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US drug and medical device market regulators are proposing changes to voluntary and mandatory post-market reporting forms used by consumers and healthcare providers for adverse events related to medical products. The Food and Drug Administration is seeking comment through July 1, 2015 on  changes  to three reporting components of its MedW...
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    Saudi Regulators Issue New Guidance on Investigational Medical Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Saudi Food & Drug Authority (SFDA), the Kingdom of Saudi Arabia’s medical device market regulator, has published new guidance on requirements for conducting clinical investigations in the country. According to the  guidance , all clinical investigations planned to take place in the KSA must obtain SFDA approval; all investigational me...
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    FDA Guidance Outlines Principles for Adaptive Design in Device Clinical Trials

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. New draft guidance from the US Food and Drug Administration (FDA) lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity. Known as  adaptive design , the method can minimize clinical trial sponsors’ resou...
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    Hong Kong Regulators Launch Voluntary Distributor Registration System

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Hong Kong’s Medical Device Control Office (MDCO), the region’s medical device market regulator, has set up a  voluntary listing and registration  option for device distributors. Distributors who apply for listing and registration will be searchable under the Medical Device Administrative Control System, the MDCO’s online portal that also ...
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    FDA Identifies More Than 20 PMA Devices Eligible for Reclassification to Class II

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has identified 21 medical device product codes as candidates for reclassification from Class III to Class II as part of a broad review of pre- and post-market data collection processes. Balancing pre- and post-market data collection is one of the FDA...
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    Major Changes Set for Taiwan’s Medical Device Registration Process

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Taiwan Food and Drug Administration (TFDA) plans to implement significant changes to its registration and approval system for medical devices, according to Emergo consultants in Taipei. The regulatory changes will take effect starting 1 July 2015.  First, TFDA will introduce a two-step review program for marketing authorization appli...
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    Health Canada to Stop Accepting Hard Copies of Class III, IV MDL Application and Fee Forms

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Canadian medical device market regulator Health Canada will stop accepting hard copies of some Medical Device License (MDL) application forms starting 1 April 2015, and will also require a separate fee form to be electronically submitted with application forms starting on that same date. According to an email notice sent out 18 March by H...
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    Pakistani Government Publishes New Medical Device and IVD Registration Rules

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Pakistan’s Drugs Regulatory Authority has issued new medical device and  in vitro diagnostic (IVD) regulatory requirements, the Medical Devices Rules 2015, which have gone into effect. The new  regulations  include requirements for conformity assessments, quality management systems, classification guidelines, authorized representation ...
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    South Korean Regulators to Require Clinical Data for Many Class IV Medical Devices

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown. Among the  proposed list of devic...
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    US FDA Amends eMDR Rules to align with Unique Device Identification Program

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US medical device regulators at the Food and Drug Administration (FDA) have issued correcting amendments  to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system. All changes will affect federal regulation 21 CFR Part...
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    New Medical Device Classifier Complicating Russian Registrations

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. A new medical device nomenclature system launched and enforced by Russian regulators is causing challenges for registrants due to incomplete and missing codes, as well as more stringent requirements for grouping products together in the same registration. Roszdravnadzor’s  Nomenclature Classification of Medical Devices by Type  (link in R...