3.2The administration of Medical Supplies and Diagnostic Control
About The administration :
The administration of medical supplies and diagnostics control is one of Central Administration of Drug control.
Responsibilities :
1-To be leaders in the field of control and quality of medical supplies and diagnostics locally and internationally, contributing to improving community health and developing the medical industries in Egypt.
2-Ensuring the quality and safety of medical supplies and diagnostics through providing distinguished and internationally accredited regulatory services, and supporting Egypt's industrial and export progress.
Objectives :
1-Provide high-quality and internationally accredited regulatory services.
2-Enhance cooperation with local and international entities in the field of medical supplies and diagnostics regulation.
3-Support innovation and development in the medical supplies and diagnostics industry.
4-Contribute to achieving health sustainability through ensuring the safety of medical products.
Goals :
1-Quality Assurance: Applying global quality standards in the regulation of medical supplies and diagnostics.
2-Training and Development: Providing training programs for professionals in the field of medical supplies and diagnostics regulation.
3-International Collaboration: Strengthening partnerships with international bodies specialized in medical supplies and diagnostics regulation.
4-Industrial Support: Providing technical and advisory support to local industries in the field of medical supplies and diagnostics to enhance product quality and increase competitiveness in international markets.
Stakeholders and How to Assist Them in Localizing Industry and Exporting Outside Egypt :
1-Manufacturers of Medical Supplies and Diagnostics :
-Providing technical and advisory support to improve product quality.
-Offering training programs for employees.
-Collaborating on developing new products that meet international market requirements.
2-Local and International Regulatory Authorities :
-Enhancing cooperation and exchanging expertise and information.
-Particiating in international programs and conferences to increase awareness and knowledge.
3-Research Institutions and Academia :
-Collaborating on research and studies related to the quality of medical supplies and diagnostics.
-Supporting innovation and development by providing accurate information and data.
4-Hospitals and Medical Centers :
-Ensuring the quality and safety of medical supplies and diagnostics used in healthcare.
-Providing technical and advisory support to improve healthcare service quality.
References
|
Regulation |
Examples of Medical Supplies |
|
ISO (International Organization for Standardization) |
Surgical instruments (e.g., scalpels, forceps), diagnostic imaging equipment (e.g., MRI machines, CT scanners), dental equipment (e.g., dental drills, chairs) |
|
EU MDR (European Union Medical Device Regulation) |
Implantable pacemakers, spinal implants, diagnostic ultrasound equipment, artificial joints |
|
ASTM International |
Surgical masks, N95 respirators, disposable face shields, protective eyewear |
|
CE Marking (Conformité Européenne) |
Endoscopes, ECG machines, defibrillators, blood glucose test strips |
|
USP (United States Pharmacopeia) |
Absorbable sutures: Polyglactin 910 (e.g., Vicryl), Polyglycolic acid (e.g., Dexon), Poliglecaprone 25 (e.g., Monocryl), Polydioxanone (e.g., PDS)<br>Non-absorbable sutures: Silk, Nylon, Polyester (e.g., Ethibond), Polypropylene (e.g., Prolene) |
Overview of the Tests Offered by the Administration to Ensure Product Quality and Safety, as well as the References Used
|
Medical Supply Name |
Test Names |
Equipment Used |
ISO Standard Name and Number |
|
Medical Gloves |
Puncture Resistance Test |
Puncture Test Device |
ISO 11193-1 |
|
|
Permeability Test |
Permeability Test Device |
ISO 16604 |
|
Medical Masks |
Bacterial Filtration Efficiency Test |
BFE Test Device |
ISO 22609 |
|
|
Fluid Resistance Test |
Fluid Resistance Test Device |
ISO 22609 |
|
Medical Syringes |
Strength Test |
Strength Test Device |
ISO 7864 |
|
|
Leakage Test |
Leakage Test Device |
ISO 7886-1 |
|
Medical Gauze |
Absorption Test |
Absorption Test Device |
ISO 9073-10 |
|
|
Strength Test |
Strength Test Device |
ISO 13938-1 |
|
Cannulas |
Strength Test |
Strength Test Device |
ISO 10555-1 |
|
|
Flow Rate Test |
Flow Rate Test Device |
ISO 10555-1 |
|
Surgical Sutures |
Tensile Strength Test |
Tensile Tester |
USP |
|
|
Needle Attachment Strength Test |
Needle Attachment Tester |
USP |
|
Blood Bags |
Leak Test |
Leak Test Device |
ISO 3826-1 |
|
|
Strength Test |
Strength Test Device |
ISO 3826-1 |
|
Catheters |
Kink Resistance Test |
Kink Test Device |
ISO 10555-1 |
|
|
Leakage Test |
Leakage Test Device |
ISO 10555-1 |
|
IV Tubing |
Burst Pressure Test |
Burst Pressure Tester |
ISO 8536-4 |
|
|
Flow Rate Test |
Flow Rate Test Device |
ISO 8536-4 |
|
Thermometers |
Accuracy Test |
Calibration Device |
ISO 80601-2-56 |
|
|
Response Time Test |
Response Time Tester |
ISO 80601-2-56 |
|
Surgical Instruments |
Corrosion Resistance Test |
Corrosion Test Device |
ISO 7153-1 |
|
|
Hardness Test |
Hardness Tester |
ISO 7153-1 |
|
Wheelchairs |
Static Stability Test |
Stability Test Device |
ISO 7176-1 |
|
|
Fatigue Test |
Fatigue Test Machine |
ISO 7176-8 |
|
Infusion Pumps |
Accuracy Test |
Calibration Device |
ISO 60601-2-24 |
|
|
Flow Rate Test |
Flow Rate Test Device |
ISO 60601-2-24 |
Location of Central Administration of Drug Control:
51st Wezaret Elzeraa, Agouza, Giza
https://maps.app.goo.gl/R9quBaDbqiWaGCMn7
Tel: 0237484988