The in vitro diagnostic (IVD) market in Egypt and Saudi Arabia is rapidly expanding, driven by an increasing demand for diagnostic testing due to the country’s growing population and a rise in chronic diseases.
Registration Process of IVDs in Egypt
1- Documents Submission through the EDA Platform.
2- File evaluation, (Accepted or Rejected or Suspended).
3- Initial revision (if accepted).
4- Final revision (after completion of requirements).
5- P.V. Evaluation in case of high risk IVDs.
6- Technical committee Evaluation.
7- Issuance of Registration License.
Governmental registration fees (EGP)
Services | Fees |
New Registration | 10000 |
Re-Registration | 7000 |
Variation | 2000 – 4000 according to variation type |
PV Evaluation – Normal track | 1500 |
PV Evaluation – Fast track | 3000 |
1- Egyptian Company Documents:
A- Legalized Contract.
B- Legalized relation letter (if found).
C- Pharmacovigilance Commitment.
D- company’s representative Delegation with the authenticity of the bank’s signature.
2-Supplier Documents:
1- Free Sale certificate and CE, Iso must be Legalized.
A- According to the European Community IVD Directive 98/79/EEC
| Class | Certificates |
General IVD Examples: *tests for hormones *cardiac markers *hematology and clinical chemistry tests | 1-DOC mentioning the IVD directive and classification. 2-FSC from country of origin or non-reference country. |
| IVDs for self -testing Examples: *pregnancy, cholesterol home test * self-testing devices | 1-DOC mentioning the IVD directive and classification. 2-FSC from country of origin or non-reference country. 3-ISO: 13485:2016 4-CE III 5-CE IV or CE V + VI or CE V + VIII |
IVDs in Annex II List B (Moderate risk) Examples: Rubella, PSA, Self-Test for Blood Glucose strips | 1-DOC mentioning the IVD directive and classification. 2-FSC from country of origin or non-reference country. 3-ISO: 13485:2016 4-CE IV or CE V + VI or CE V + VIII |
| IVDs in Annex II List A (High risk) Examples: HIV, Hepatitis, ABO Blood Grouping | 1-DOC mentioning the IVD directive and classification. 2-FSC from country of origin or non-reference country. 3-ISO: 13485:2016 4-CE Annex IV (Exclud.4&6 sec) +Annex IV (Sec4 Annex V+VII) |
B- According to USA.
| Class | Certificates |
| Class I | 1-CFG without GMP 2-DOC mentioning the classification. 3- Code of federal regulation 21 CFR 862, 21 CFR 864,21 CFR 866 |
| Class II, and III | 1-CFG with GMP or CFG + ISO 13485:2016 2-DOC mentioning the classification. 3- Code of federal regulation 21 CFR 862, 21 CFR 864,21 CFR 866 |
C- According to Canada.
| Class | Certificates |
| Class I | 1-Declaration letter mentions full medical device list submitted to the Egyptian health authority 2-DOC acc. To Canadian regulation mention the classification 3-Manufacturer certificate to cover export of medical devices (= FSC) issued from: the (HPFBI), Health Canada 4- Medical device establishment license |
| Class II, III, IV | 1-Declaration letter mentions full medical device list submitted to the Egyptian health authority 2-Medical device active license (In case Medical device active license is issued for medical device family, medical device group, or medical device group family) N.B: the declaration letter will be sent to the health Canada to confirm that the license covers the whole medical device list 3-DOC acc. To Canadian regulation mention the classification 4-Manufacturer certificate to cover export of medical devices (= Free sale) issued from: The Health Products and Food Branch Inspectorate (HPFBI), Health Canada 5- ISO 13485:2016 |
2- Technical documentation:
1- Administration
- Name of manufacturer
- Address of manufacturer
- Address of any associated manufacturing sites
- Statement of legal liability
- License of manufacturing no.
- Name of authorized person.
- Authorized person Delegation Letter.
- Name of contact person
- Tel
- Fax
- E- mail
- Web address
2- Device description
- Name of the device
- Brand name
- Variant: codes, references, and sizes
- Intended use
- Description of individual components included in the IVD
Where applicable, the following should also be provided
- A description of the accessories, other IVDs and other products that are not medical devices which are intended to be used in combination with the IVD
- For assays requiring instrumentation, a description of the relevant instrumentation characteristics or details of dedicated instrumentation to be used
- A description of any software to be used
- A complete list of any configurations or variants of the IVD, other than kit size, that will be made available.
3- Device History (Transitional State only)
- A summary of the product history in domestic market and any other countries.
- A list of countries or regulatory jurisdictions, approximate numbers of IVDs and/or period of time supplied, summary of any adverse events, recalls, corrective/preventive actions or refusal to approve for supply.
4- Performance evaluation (as statement)
- – diagnostic sensitivity
- – diagnostic specificity
5- Labeling
- Inner and outer labels
- Instructions for Use
- Advertising material (e.g., brochures, web-pages, published advertisements, etc.), where available.
6- Manufacturer testing reports of the final product
Example of batch release certificate
7- Commitment to follow up with medical device PMS.
8- Representative sample.
الدليل التنظيمي الخاص بتسجيل وتداول الكواشف المعملية والتشخيصية
