LEGIPHARMs Top Medical Devices Regulatory News - April 2013 | N01

LEGIPHARM International publishes monthly Top Medical Devices Regulatory News (TMDRN ), a one-page free highlight of main national Medical Devices (MD) regulatory issues from the G20 member States TMDRN is free: To receive it send us your email address to topmd@legipharm.com For a more complete information on the International Medical Devices Regulatory issues: See International Medical Devices Regulatory NEWS-IN-BRIEF, the LEGIPHARMs e-newsletter http://sites.google.com/site/legipharmnews

Argentina

Australia

Brazil

Canada

China

European union Saudi Arabia Turkey

France

Germany

India

Indonesia

Italy Japan Mexico

Russia

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South Korea

UK

USA

ANMAT (NCA): New registration requirements for medical products - February 2013 (Spanish) http://www.anmat.gov.ar/comunicados/nuevos_requistos_prodmedicos_727-2013.pdf TGA (NCA): Joint reclassification advice - Kinds of medical devices - March 18, 2013 (English) http://www.tga.gov.au/industry/devices-reforms-joint-implants-kinds.htm ANVISA (NCA): Endoscopic activities specific rules - March 5, 2013 (Portuguese) http://portal.anvisa.gov.br/wps/content/anvisa+portal/anvisa/sala+de+imprensa/menu++noticias+anos/2013+noticias/servicos+de+endoscopia+ganham+regras+para+seguranca+do+paciente CADTH (NCA): Osteostimulative Bone Graft Substitutes or Demineralized Bone Matrix Clinical Effectiveness and Safety - February 28 (English) http://www.cadth.ca/media/pdf/htis/feb2013/RB0568%20Bone%20Graph%20Substitute%20Technologies%20Final.pdf SFDA (NCA): Electromagnetic compatibility standard YY 0505-2012 of medical electrical equipment - March 14, 2013 (English) http://eng.sfda.gov.cn/WS03/CL0757/79080.html MD Notified Bodies Association: Key points in MD Regulation - February 2013 (English) http://www.team-nb.org/documents/2013/TEAM-NB-vision-on-revision-medical-device-regulationspresentation-in-EP-Workshop-26-2-2013.pdf ANSM (NCA): Annual sales reporting to ANSM 2013 - Introduction and Explanatory Notes 2013 - February 25, 2013 (French) http://ansm.sante.fr/content/download/39289/514298 Bfarm (Federal CA): Infusion line - multiple connector with vented caps - March 11, 2013 (German) http://www.bfarm.de/DE/Medizinprodukte/riskinfo/empfehlungen/Infusionsleitung_2666-12.html CDSCO (NCA): Frequently Asked Questions on Registration and Import of Medical Devices in India - February 21, 2013 (English) http://cdsco.nic.in/FAQ-IMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf Binfar (MoH/MD): Binfar Meetings & Medical Devices 2013. Among strategic actions: MD appropriate use, MD affordability, MD needs - March 7, 2013 (Indonesian) http://www.binfar.depkes.go.id/konten.php?id=68 MD Directorate General (MoH): Lists of manufacturers of custom-made MD - March 18, 2013 (Italian) http://www.salute.gov.it/dispositivi/paginainternasf.jsp?id=15&menu=elenchi PDMA (NCA): New MD aproved from April to September 2012 March 4, 2013 (English) http://www.pmda.go.jp/english/service/pdf/list/NewmedicaldevicesFY2012.pdf COFEPRIS (NCA): More than 1 million MD with violations of standards - seizure company Medline Mexico - gloves, catheters, others MD - March 13, 2013 (Spanish) http://www.cofepris.gob.mx/Documents/NotasPrincipales/13032013.pdf Roszdravnadzor (NCA): New Rules for state registration of medical products Information letter January 9, 2013 (Russian) http://roszdravnadzor.ru/i/upload/files/1357732439.67819-9066.pdf SFDA (NCA): Exhibits Fake Commodities at the 3rd Arab Forum for Counterfeit Combating & Protection of Proprietary Rights - Fake biomedical devices March 4, 2013 (English) http://www.sfda.gov.sa/en/news/Pages/homenews04-03-2013a1.aspx IDC (body of the Economic Development Ministry): MD (Surgical instruments, HIV test) among sectoral focus areas of IDC - March 2013 (English) http://www.westerncape.gov.za/text/2013/March/idc-dti-incentives-roadshow.pdf KFA (NCA): Increased interest for MD - Increased age and health - Contact lens, hearing aid, dental implant, sphygmomanometer, CT - February 2013 (Korean) http://www.kfda.go.kr/index.kfda?mid=56&seq=19741&cmd=v MD Agency: Notification for withdrawing Kalitests NB status within the scope of MD Directive about authorisation to issue EC certificates for MD - March 13, 2013 (English) http://www.iegm.gov.tr/Folders/News/Folders/T%C4%B1bbi%20Cihaz%20De%C4%9Ferlendirme%20ve% 20Kay%C4%B1t%20%C5%9Eube%20M%C3%BCd%C3%BCrl%C3%BC%C4%9F%C3%BC/Announcement_ c048077.pdf MHRA (NCA): An Innovation Office to encourage the development of novel medical products and devices - March 11, 2013 (English) http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON249612 FDA (NCA): Draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex - March 8, 2013 (English) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm342855.htm

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