Italy medical devices Regulation

Regulatory Affairs

Colored eye lenses corrective Hidrocor, Hidrocharme, Natural Colors of solotica range The Agency has informed the public in April 2011 of marketing through websites based in France and Switzerland, eye corrective colored lenses of Solotica brand. they do not have the CE mark under the European Directive 93/42/EC on medical devices, and therefore should not be used.

The Agency was informed by the company COVIDIEN the existence of Durasensor Nellcor SpO2 sensor (DS-100A) counterfeit for pulse measurement. The manufacturer has informed us have noted the presence of counterfeit products in the Netherlands and Germany. Nothing so far no evidence of a bet on the French market for these fakes.

It is recalled that counterfeit health product is, in essence, subject to any assessment of its compliance with the regulations. Therefore, it should not be used.

The Agency was informed by ETHICON the existence kits circular Proximate ® PPH stapler (staplers and accessories) for the treatment of counterfeit prolapse and hemorrhoids. Counterfeiting is on a Ethicon Endo-Surgery product "Proximate ® circular stapler kit - PPH03 -. Lot number F4N12N The manufacturer has informed us have noted the presence of counterfeit products in Italy Nothing, so far, no. ' attests to put on the French market for these fakes.

It is recalled that counterfeit health product is, in essence, subject to any assessment of its compliance with the regulations. Therefore, it should not be used.

The Agency has been informed of the availability of internet counterfeit copies of products filling wrinkles RESTYLANE ® manufactured by Q-Med AB (Sweden).

These products are labeled RESTYLANE ® PERLANE on the outer packaging, but the inner blister indicates a different name "LIKOMER" and password "51-19101-09" and "51-19101-03".
They contain a syringe packed in a flexible paper / plastic bag, while the original manufacturer has a syringe in a blister molded thermo solid.

0562 CE marking is affixed on the label, but that number does not correspond to that of a competent notified to issue a certificate of compliance with the European Directive 93/42/EEC body.
The company Q-Med AB confirmed not put on the French market products under the name "LIKOMER" and that RESTYLANE ® devices manufactured by QMED bear the CE marking 0344.


gastroprofi.wordpress.com
2006-02-20 17:02:02 by Bioseeker

8 years in biotech

I've been working consistently in the biotech field, after a BA in Psychobiology for 8 years.
-Regulatory Affairs deals with getting FDA approval of new drugs and medical devices.
I went to the Biospace job fair last month but haven't got any calls. I'm wondering if its b/c I currently reside in LA. I'm thinking of moving down there and looking for something fast thru a temp agency. Any advice?


visit site 2009-01-11 15:13:59 by windshadow

More from hsi

Last month, a group of FDA scientists sent an SOS to Representative John D. Dingell, chairman of the House Committee on Energy and Commerce. The letter calls for "urgent intervention" due to "serious misconduct" by managers of the Center for Devices and Radiological Health (CDRH) – the FDA division that oversees everything from imaging equipment to breast implants.
So what constitutes "serious misconduct"?
Here's how the scientists put it: "There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices


Lens design 2007-09-08 13:08:25 by -------

Chip implants shown to cause cancer, a

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But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had "induced" malignant tumors in some lab mice and rats

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