New US FDA FAQ Clarifies De Novo Medical Device User Fee Requirements

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MDUFA IV: US FDA Sets Performance Goals for De Novo Medical Device Reviews

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Changes to Australian Medical Device Recall Process Set for Early 2018

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IMDRF Pushes Wider Use of Registry Data in Medical Device Regulatory Decisions

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New “U” Series Power Amplifiers From 10kHz – 1000 MHz

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FDA Names Digital Health Pilot Program Participants

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EU Commission Proposes Codes for Medical Devices Under MDR/IVDR

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Researchers Unveil Revolutionary Silicon Chip Circulator

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Antenna in Alaska Enhances Spacecraft Communication

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Standards and Regulation News

Electrical Products

Brazil
Anatel Act No 11542 of technical requirements for restricted radiation equipment
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EAEU
Adopts Decisions on Standards Implementing Technical Regulation on RoHS in EEE
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India
Compulsory registration Scheme: Phase 3 products-Release of the Official Gazette notification
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Implementation of IS 616:2017-Audio, Video and similar electronic apparatus-Safety requirements
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Taiwan
Proposed Drafted Technical Specifications for Narrowband Terminal Equipment of Mobile Broadband Business
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Household Goods, Fitness and Recreation

Canada
Proposed Draft Corded Window Coverings Regulations
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Ecuador
Proposed Draft Amendment to Technical Regulation on Safety of Toys
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European Union
Publication of Harmonised Standards for General Product Safety, Commission Communication 2017/C 267/03
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Kenya
Notice No. 2356/2017: Prohibition on the Use, Manufacture and Importation of Plastic Bags
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Mercosur
Draft revision of the Textile Labelling Mercosur Regulations
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Taiwan
Revised Mandatory Commodity Inspection Rules for domestic use pressure cookers
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Ukraine
Draft Resolution Approving Technical Regulations on Safety of Toys
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USA
Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates: Determinations Regarding Certain Plastics
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CPSC Approves new federal mandatory standard for Infant Bouncer Seats
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Vietnam
Draft National Technical Regulation on the safety of synthetic resin implement, container, and packaging in direct contact with foods, milk and milk products
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Mobility

European Union
01 series of amendments to the Regulation ECE No. 137 has been released
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03 series of amendments to the Regulation ECE No. 94 has been released
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06 Series of amendments of Regulation 105 has been released
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COMMISSION DELEGATED REGULATION (EU) 2017/1576 regarding the Acoustic Vehicle Alerting System requirements
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The new WLTP emission test cycle
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USA
Updated federal driverless policy guideline released
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Chemical Testing

Mexico
New version of NOM-106-SCFI-2017 published for the NOM marking in products
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South Korea
Draft amendment of Technical Regulation for Electromagnetic Compatibility
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