The new article pays special attention to the classification of recall actions taken in order to ensure the continuous safety of medical devices allowed for marketing and use in the country.
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The Egyptian Drug Authority (EDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to recalls for medical devices. The guidance provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature. Moreover, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The scope of the guidance covers, inter alia, the matters related to the classification of recall actions as set forth under the existing legal framework.
Class I Recalls
According to the guidance, Class I recalls are the most severe and involve products that pose a significant health hazard, potentially leading to serious health problems. These recalls typically involve dangerous or defective products.
Examples include:
- Microbial contamination in sterile injectable or ophthalmic products.
- Correct product but incorrect strength, leading to serious medical consequences.
- Chemical contamination with serious medical consequences.
Class II Recalls
Class II recalls concern products that might cause temporary health problems or pose a minor threat of a serious nature. These recalls are less severe than Class I but still important for public health.
Examples include:
- Mislabeling, such as wrong or missing text or figures.
- Missing or incorrect information in leaflets or inserts.
Class III Recalls
As explained by the authority, Class III recalls are for products that are unlikely to cause health problems but violate labeling or manufacturing laws and guidelines. These recalls are the least severe and often involve regulatory compliance issues rather than direct health risks.
Levels of Recall Action
In addition to the above classification, the relevant legislation provides for different levels of recall actions based on the criteria outlined below:
- Consumer or User Level: Recalls at this level target individual consumers, patients, doctors, and hospitals. This is the most direct level of recall action.
- Retail Level: Recalls at the retail level involve intermediaries such as pharmacies and hospital pharmacies, stopping the defective product before it reaches the consumer.
- Distributor Level: This level involves all stages of distribution between the manufacturer and retailer. Recalls at this level are aimed at preventing the defective product from reaching retail or consumer levels.
Execution of Recalls
For Class I recalls, actions must be executed at the distributor, retail, and consumer levels. Public announcements should be made through various media, including electronic media, newspapers, television, and radio.
Distribution companies are also required to note the recalled item on their sales invoices. Class II recalls typically extend to the distributor and retail levels, while Class III recalls are confined to the distributor level.
Phases of Recall
The document also describes the main phases of recall as set forth under the applicable legislation.
- Initiation Phase: This phase involves identifying the problem, assessing the risk, deciding whether to recall and planning the recall action.
- Implementation Phase: In this phase, the recall action notice is issued by the sponsor, and the requested recall action is undertaken.
- Review Phase: The effectiveness of the recall action is monitored and reviewed by the sponsor with oversight by the relevant authority.
Product Defect Reporting
The applicable legislation also establishes detailed requirements for product defect reporting. In particular, market authorization holders, product registrants, manufacturers, and importers of medicinal products, along with the distributors and pharmacies in the supply chain, must report any defects in medicinal products within their authorization scope that could lead to a recall or abnormal supply restrictions, such as a manufacturing suspension.
If affected products have been imported into the Egyptian market, the MAH must report any related alerts or enforcement actions taken. Defects that compromise product safety, quality, and efficacy include faulty manufacturing, product deterioration, detection of falsified medicines, or other serious quality problems.
Market authorization holders and suppliers should have systems to investigate, review, and report these defects to the EDA, and if necessary, recall the affected products promptly. The company must undertake actions as directed by the EDA, including recalls.
The company is responsible for implementing, following up, and notifying relevant authorities, the supply chain, and customers about any recalls. If the recalled batch or product is exported, the MAH must notify the importing entity and provide proof of receipt to the EDA.
Classification of Product Defects
As explained by the EDA, there is also a separate classification system specifically for product defects, namely:
- Critical Quality Defects: Defects classified as critical are potentially life-threatening or could cause serious health risks.
- Moderate-Risk Quality Defects: These defects could cause illness or mistreatment with potentially non-serious medical consequences but are not classified as critical.
- Low-Risk Quality Defects: Defects classified as low-risk are unlikely to pose a significant hazard to health.
Information to Include in Initial Product Defect Reports
In order to assist the parties involved in recall activities, the document also outlines the scope of information to be included in the respective reports. According to the guidance, the initial report of product defects should include as much detail as possible, but reporting should not be delayed to gather full information.
The minimum information required includes:
- Product information (name, strength, dosage form);
- Description of the defect;
- Number of affected products or batches and total number of packs;
- Date of occurrence;
- The expiry date of affected batch(es);
- Date of last distribution of the affected batch(es) to the market;
- Full contact details for further information.
Timeframes for Initial Quality Defect Reporting
The applicable regulation also establishes special timeframes for quality defect reporting in order to ensure that critical information is escalated without undue delay. These timeframes depend on the severity of the issue in question.
- Critical Defects: Critical defects must be reported within two working days. Immediate measures should be taken to minimize risk, even outside working hours.
- Medium and Low-Risk Defects: These defects should be reported within 15 calendar days.
Follow-Up Investigation and Risk Assessment Report
After the initial report, the MAH must submit an investigation report, health hazard assessment, and corrective and preventive actions (CAPA) plan to the EDA.
The follow-up report should include:
1. A detailed description of the defect
2. Root cause analysis
3. Detailed information on defect detection, date of occurrence, and collection site
4. Evaluation of defective product samples compared to retained samples from the same batch
5. Local and overseas distribution records of affected batches
6. Indication of whether the product was supplied to the UPA or under tender contract or pending tender consideration
7. Review of previous complaints, quality defect reports, and relevant information for recurring problems
8. Health hazard assessment on the potential short-term and long-term consequences of the defect to intended users
Conclusion
In summary, the present guidance describes in detail the applicable classification rules pertaining to recalls and relevant activities. The document also outlines the scope of information to be included in such reports in order to ensure their completeness.
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