LONDON, UK, October 16, 2008
/24-7PressRelease/ -- Quality First International has issued an alert to all medical device companies intending to sell their medical device in Italy beyond 31 December 2008: Italy has introduced various changes in healthcare regulations, among which is the need for any medical device placed on the Italian market to be registered on a central, coded database according to two Italian Decrees issued in February 2007 and on 20 March 2007 by the Italian Ministry of Health. The database becomes Law on 31 December 2008, meaning that any product not registered will be proscribed, regardless of whether it bears the CE Marking of Conformity.
"Registration of products can take up to a month typically and can only be accomplished by certain trained individuals appointed by the manufacturer to access, enter and edit information on the database", explains Haroon Atchia, Technical Director and CEO at Quality First International, the London-based medical devices regulatory consultancy. "The procedure requires obtaining a username and password from the Italian Ministry of Health and a smart card to enter a digital signature for data processing. Quality First International is among a number of professional companies able to perform the registration and act as custodian of the licence awarded on behalf of our clients."
Coding of products will be according to an Italian system distinct from other schemes such as GMDN or UDMNS. The Repertorio database is separate also from reimbursement controls in Italy. Quality First International (QFI) can commence the registration on a company's behalf speedily on receipt of instructions. The new obligations for registration complement QFI's other established business programmes: the EU Authorised Representative service and Registar*.
About Quality First International:
Quality First International Limited is a London-based medical devices consulting company specialising in solving its clients' regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, USA, Japanese, Australian, Canadian and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants.
For further information:
Marija Capek, PR and Press Officer, Tel: +49 (0)621 166 2326, Email: marija@qualityfirstint.com, Web: http://www.qualityfirstint.com.
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