3- Central Administration of Drug Control

3.1 Reference Lab:

About The administration:

The administration of reference lab is one of general administration of reference lab - the Central Administration of drug control.

Responsibilities:

1-R&D hub that provides regulatory-grade service to pharmaceutical and Medical Device manufacturers.

2-Offers fast-track, cost-effective consultancy services to support development of safe & effective medicines.

3-Facilitate Medical Devices and Diagnostics industry modernization & localization of innovative technologies.

4-Helps manufacturers establish benchmarking of their Medical Devices products above & beyond regulatory compliance.

Medical Device Conformity Assessment

• Medical Devices in Dosage Form

1. Formulation Study
2. Microbiological Analysis
3. Biocompatibility Studies
4. Analysis

• Mechanical Performance Testing for Non-Dosage Form MD

1. Tensile Testing
2. Hardness Testing
3. Corrosion Testing
4. Impact of strength

• Biocompatibility Studies

1. Cell Based Testing
2. Irritation & Sensitization
3. Acute & Chronic Systemic Toxicity
4. Implantation in Animal Model

Submission Form

• Sending E-Mail for Reference lab including Request

Consultation Services:

• lab@edaegypt.gov.eg

Regulatory Grade Services:

• pr@edaegypt.gov.eg
• Replying with Technical offer including (Price – Due Date – Requirements) Depend on type of Medical Device
• Guidelines ISO 10993

Procedure for Submitting to Reference Lab

• Send a request via email to the addresses provided above, including the type of data related to the product and the tests to be conducted.
  You will receive a response with a price quote that includes:
  • The cost of the study
  • The duration for completing the study
  • Analysis requirements
  • Studies will be conducted according to ISO standards 10993.

Location of Central Administration of Drug Control:

51st Wezaret Elzeraa, Agouza, Giza

https://maps.app.goo.gl/R9quBaDbqiWaGCMn7

Tel: 0237484988