Medical devices Regulations Egypt

Medical device industry lobbies IRS, Congress to dodge health law

List of consulting services to registration and licensing .

The registration and licensing of medical products takes place in Egypt on the Central Administration for Pharmaceutical Affairs (CAPA), the body responsible for the medical device market department of the Egyptian Ministry of Health.

Emergo Group can assist our office in Cairo medical device manufacturers throughout the registration process in order to maintain the market share in Egypt.

Medical products without a local branch in Egypt must also appoint an authorized representative, the so-called Egyptian authorization holder (Egypt Registration Holder, ECA), which communicates with the authorities on their behalf. Emergo Group can act as your ECA to ensure a smooth CAPA registration.

Egyptian medical examinations by the CAPA

The Egyptian approval system for medical devices is very similar in the European Union. If you are familiar with the European medical device directives, you can use this knowledge in the classification of products, in the performance of quality system and other regulations in Egypt.

As your medical advisor for Egypt, we can help with the CAPA you prepare all the necessary documents for product registration.

CAPA for medical devices registration required documents

The following documents are required for a registration request to the Egyptian authorities:

  • Proof of the ISO 13485 quality system certification (for sterile products)
  • Free Trade Certificate of the United States, Canada, Europe, Australia or Japan
  • Description and purpose of your medical device
  • Declaration of Conformity Certificate
  • Clinical data, test reports and other data to demonstrate the safety and efficacy of the product, if necessary

For more information or a free quote on our services for the registration of medical devices in Egypt are available on request.

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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?

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

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

Chip implants shown to cause cancer, a

"When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
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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