Egyptian Drug Authority

Services > Drug Policy & Planning Center > Planning and Approvals to Import Medical Devices > Definitions


Medical Devices:

Is any medical device or machine tool application of medical or medical use, whether alone or with any other supplements such as those required for special applications are running, which developed for human use of the following goals and targets:
  Diagnose, prevent, or control or cure or mitigation of disease analgesia.
  Diagnosis, control or cure or mitigation of analgesia or compensation for any disability or disability.
  Check or compensation or to improve the work of Physiology and autopsy.
  Prevent pregnancy.

Such as:
  Devices that are running through a power source.
  Devices planted the human body, and self-working power source.
  Purpose-designed equipment for specific purposes.
  Devices designed for clinical studies.
  Hardware diagnostic test.

And which cannot be achieved through:
  Medical drugs.
  Immune serum.

Classification of Medical Device:

Are classified as medical devices based on the degree of seriousness or entails a medical device into four main groups:
  Group I (low-risk).
  Group IIA (medium risk).
  Group IIB (high risk).
  Group III (higher-risk).

And according to the classification or entails a medical device is selected the required quality certificates as follows:

Class I
A. Sterile or Measuring …………………… Required certificate of CE-Annex V
B. Non-sterile, non-Measuring ……………Required Declaration of Conformity

Medium risk:
Class IIA
Required certificate of CE-Annex IV or Annex V or Annex VI

High risk:
Class IIB
Required certificate of CE-Annex II.3 or Annex IV+IIIb or Annex V+III or Annex VI+III

Higher risk:
Class III
Required certificate of CE-Annex II.3 +II.4 Or Annex IV+III Or Annex V+III

CE Marking

Certificate of credit issued by a European laboratory accredited correspondence is to make sure of the validity of the certificate.

Free Sale:

The highest health authority to issue a certificate of free circulation, For example:Department of Health in the United States FDA issued a certificate (Certificate to a Foreign Government) and this certificate implies that the FDA has approved the circulation in the United States entails a circulation in the United States.
In Europe and the testimony of the free circulation implies that entails a carry CE Mark.As you can see all the governments to the Free Sale Certificate is necessary for the handling of any product or accessory of a medical product, whether domestic or imported.

Declarations of Conformity:

Certificate issued by the manufacturer containing the name of the product and the use and classification and specification of manufacturing and it's on the responsibility of the factory.