Sept 04, 2007
New Italian device registration procedures and fees
In order to improve the previous registration process, new procedures for registering medical devices distributed in Italy into a new databank within the Ministry of Health (MOH) web portal has been approved (Italian decree, 7 March 2007). The new databank will also be used to generate a complete listing ("Repertorio") of devices that are currently sold to the Italian National Health System. In addition, registration is intended to enhance traceability by assigning a registration number to each device, thereby facilitating MOH market surveillance and vigilance activities. The new registration requirements apply to medical devices, complete systems and kits (for operating room) and active implantable medical devices already marketed or which will be marketed in Italy. The decree does not cover In Vitro Diagnostic Devices and devices intended for clinical investigations.
May 10, 2007
Mission to China - June 16-26, 2007
Obelis European Authorized Representative Center will participate to the next BELGIAN ECONOMIC MISSION TO THE PEOPLE's REPUBLIC OF CHINA & Hong Kong SAR Headed by H.R.H. Prince Philippe of Belgium from June 16/26, 2007.
For more information, please contact doram@obelis.net
April 24, 2007
Cosmetic Safety Assessment
From now on, and additionally to the European Authorized Representative services, OEARC is proud to provide you with safety assessment services according to article 7a.1 (e) of the Cosmetic Directive 76/768/EEC. For additional information or a quote, please contact doram@obelis.net
April 24, 2007
ISO, Reimbursements, CE Marking & FDA Regulations Seminar - April 30, 2007
Occurring in Tel Aviv on the 30th April, the seminar will be under the umbrella of the Israeli Chamber of commerce with the collaboration of the Israeli Export Institute. There will be B2B meetings after the lectures and on the 2nd day of the seminar that will be dedicated to meetings.
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March 29, 2007
Revision of the directives on medical devices
The Revision of the directives on medical devices on the proposal for a directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives (A6-0332/2006) has been adopted by 645 votes in favor to 15 against with 4 abstentions, with amendments. Please click here read the full report.
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September 30, 2006
Obelis is excited to announce the latest One Link One Solution advancement While still retaining the core group of international compliance experts, One Link One Solution will begin the process of expanding its boundaries
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July 12, 2006
Israel Export and International Corporation Institute Seminar
Obelis s.a. was invited to present in the 2006 Israel Export and Corporation Institute Seminar along with two major One link One Solution Associates
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July 11, 2006
Hospitalar
This year marked Obelis’ first exhibition at Hospitalar. “We exhibited with our One Link Associate EGmont and it was a great success,” remarks Miguel Ohn, an Obelis Project Manager. This Exhibition was....
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July 4, 2006
Obelis O.E.A.R.C. is excited to announce the unique collaboration with S.E.O. Advanced
Being seen on the internet in nowadays is one of the most important marketing tools. Therefore, Obelis O.E.A.R.C. is very excited about its unique collaboration with S.E.O. Advanced since it allows O.E.A.R.C. clients to improve their internet marketing strategy and thus penetrate more effectively the European market.
S.E.O. Advanced sprl. is a Belgian company providing Multilingual Search Engine Optimization (SEO).
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July 3, 2006
European Language Requirements:
CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called Product Directives which contain the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. What this in essence means for the manufacturer is that CE Marking in essentially a passport to Europe allowing manufacturers to freely circulate their products within the European market. In labeling a product for sale under the CE mark, guidance for language requirements must be sought from the appointed Competent Authority within each country. These standards typically differ depending upon the end-user, as well as whether the product is intended for professional or for consumer use. If the expectation is that the professional has a good understanding of English or another EU standard language, the requirements for translation are lessened. However, if the product is intended for use by consumers, then the requirements may differ significantly and in fact often require adherence to specific languages depending upon the individual member state which may include translation into one or even more national or local languages>
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July 28, 2006
AACC 2006: A Positive Experience with Positive Responses
This year Obelis E.A.R.C. attended the AACC exhibition as an exhibitor, together with Qserve Group as one of the major OneLink:OneSolution partners, this combination led to a very successful exhibition…..
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