The new article explains the three steps testing approaches and highlights the key points associated thereto. The document also addresses the aspects related to documentation and reporting.
The Pharmacy and Poisons Board, the Kenyan regulating authority in the sphere of healthcare products, has published a guidance document dedicated to post-marketing surveillance. The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers, importers, distributors, and other parties involved to ensure compliance thereto. Provisions of the guidance are non-binding in their legal nature and are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should it be necessary to reflect the respective changes to the underlying legislation.
Three Steps Testing Approach
According to the table provided in the guidance, the three steps testing approach is comprised of the following levels:
- Level 1. Labeling, visual inspection, physical inspection. At this stage, all the samples of medical devices should be subject to visual inspection.
- Level 2. Identification (TLC), disintegration test, verification. At this stage, the scope of testing to be performed will depend on the results of the testing conducted during the previous stage. Thus, depending on whether the samples are compliant with Level 1, further actions will be different.
- Level 3. Compendial. This level applies to all the products that do not comply with previous levels.
Data Management, Analysis, and Reporting
The document further describes the approach to be applied concerning data management, data analysis, and reporting. According to the guidance, data quality should be assured through the provision of training to sample collectors and by the use of a standard sample collection form as well as a facility detail form with close supervision of the sample and data collection process. The authority also mentions that all paper copies should be duly kept by the responsible entity to be provided for review upon request. It is also necessary to keep the results from field screening activities. Under the general rule, all the documents should be retained for at least one year from the sampling date. The parties involved in testing (inspectors and laboratories) should communicate the test results once they become available.
Based on the information received, the authority will decide on further actions to be taken. For instance, the authority may request additional samples to be collected, or additional information to be received, as well as any other actions that are reasonably necessary to ensure the proper performance of medical devices and the safety of the patients. Following the applicable legislation, the results of post-marketing surveillance activities will be communicated by the authority to the parties responsible for medical devices within 7 days.
The authority also mentions that a detailed technical report should be prepared, addressing the most important aspects related to the product in question. Should any non-compliances be identified, the appropriate investigation should be carried out, resulting in special actions taken; while the findings will be communicated to all the parties involved in operations with the product.
Documentation: Additional Information
The guidance also contains annexes providing additional information to be considered in terms of post-marketing surveillance. In particular, the document provides the forms to be used to report adverse events or other issues related to healthcare products.
According to the guidance, the form for reporting suspected poor-quality medical products and health technologies requires the following information to be provided:
- Indication of the type of medical product in question (e.g., medicinal product or medical device),
- Details necessary to identify the product (e.g., brand name, date of manufacture and expiry, names of manufacturer, distributors, and suppliers);
- Details about complaints related to the device, including the nature of an issue (e.g, packaging, software, etc.);
- Storage conditions;
- Details of the reporting person.
The document also prescribes the form to be used for rapid alert notification of a quality defect. As in the case with the previous form, the information to be submitted to the authority should include, inter alia, the following information:
- Details about the device in question, including the brand name, batch number, and manufacturing date;
- Details of the manufacturer, Market Authorization Holder (an entity responsible for a medical device), as well as the parties involved in distribution;
- Details about the actions taken to ensure the safety of patients.
To assist the parties involved, the guidance also provides a table on a summary of the information required for risk-based sampling and testing. The aspects addressed include the following ones:
- Selection of region, County, and Sub-County to sample from;
- Selection of medicines;
- Selection of sampling sites/facilities;
- Selection of sampling methods;
- No. of dosage units / Number of samples;
- Sample testing.
For instance, the form indicates the particular testing to be performed depending on the testing objectives; as well as the capacity of the laboratories involved.
The document also provides a sample collection form to be used to provide information about the samples collected. According to the guidance, the information to be provided includes, inter alia, such details as:
- Origin of a sample (name and code of the manufacturing facility);
- Information about the product in question (brand and product name, manufacturer’s details, package size, etc.);
- Comprehensive information about the manufacturing facility, including the indication of the country, sector, facility type, as well as the details of a contact person).
In summary, the present guidance describes in detail the regulatory requirements in the sphere of post-marketing surveillance. The document highlights the key points related to the activities undertaken to ensure the continuous quality and safety of medical devices allowed for marketing and use in Kenya, outlines the spheres of responsibilities of all the parties involved, and also provides clarifications regarding the documentation related to the process.
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