Table 1 Final criteria and scoring functions
From: A multicriteria decision analysis (MCDA) tool to purchase implantable medical devices in Egypt
Criterion | Scoring options | Score |
|---|---|---|
Technical characteristics of the medical device (To assure fulfilling the technical specifications) | Fulfills 100% of the technical specifications required | 100% |
Fulfills 90– < 100% of the technical specifications required | 80% | |
Fulfills 80– < 90% of the technical specifications required | 60% | |
Fulfills 70– < 80% of the technical specifications required | 10% | |
Fulfills < 70% of the technical specifications required | Exclusion | |
Country of origin | Reference countries* for both legal and actual manufacturer or local product | 100% |
Reference country* of the legal manufacturer or actual manufacturer | 75% | |
Non reference countries for both | 40% | |
Use in reference countries (To assure previous use in countries with good standards of quality) | CFG certificate from FDA | 100% |
Canadian free sale certificate + ((medical device active license + MDSAP certificate) or medical device establishment license) | 80% | |
European CE certificate + free sale certificate from a reference country* | 75% | |
European CE certificate only (for local products only) | 50% | |
Supplier reliability (To assure the reliability of the supplier concerning quantities and delay) | Supplier fulfilled more than 90% of the committed requirements in the last 3 years | 100% |
Supplier fulfilled 70–90% of the committed requirements in the last 3 years | 80% | |
Supplier fulfilled 50–70% of the committed requirements in the last 3 years | 60% | |
Did not supply previously | 50% | |
Supplier fulfilled < 50% of the committed requirements in the last 3 years | 10% | |
Previous use of the product | Listed in the UPA platform | 100% |
Supplied to governmental or non-governmental organizations in the previous 2 years | 70% | |
Was not supplied previously | 45% | |
Instant replacement within product variety (To assure supplier flexibility) | Supplier provides instant replacement within product variety (During surgery on shelf stock) | 100% |
Supplier does not provide product replacement for different sizes/ types | 15% | |
Pharmacovigilance system | ||
(EDA will provide evidence for the efficiency of the pharmacovigilance system from 1 year as a maximum) | Supplier has an efficient pharmacovigilance system | 100% |
Supplier has a moderate quality pharmacovigilance system | 70% | |
Supplier has a low-quality pharmacovigilance system | 20% | |
No pharmacovigilance system | Exclusion | |
Refund/Replacement within product variety (To assure replacing unwanted or expired products) | The product was present in the stagnant report 1 time or less in the last year | 100% |
The product was present in the stagnant report 2 times subsequently in the last year | 70% | |
The product was present in the stagnant report 3 times subsequently in the last year | 50% | |
The product was present in the stagnant report 4 times in the last year | 20% |