The new article provides additional clarifications regarding certain specific aspects related to post-market surveillance, including the activities to be undertaken by the parties involved to ensure continuous safety and proper performance of medical devices placed on the market.
The Pharmacy and Poisons Board of the Kenyan Ministry of Health has published a guidance document dedicated to post-market surveillance. The document is intended to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be considered by medical device manufacturers, healthcare institutions, and other parties involved in operations with medical devices. Provisions of the guidance are non-binding and are not intended to introduce new rules or impose new obligations, but rather to assist in ensuring compliance with the current regulatory framework. The authority also reserves the right to amend the recommendations provided in the guidance, should it be reasonably necessary to reflect the respective changes to the underlying legislation.
Procedure for Post-market Surveillance Activities
According to the applicable regulatory requirements, the authority is responsible for developing and implementing an efficient reporting system to be used to collect and analyze information deriving from complaints regarding medical devices used in the country. The authority is also obliged to undertake a rigorous investigation in case of reasonable suspicions related to the quality of the products placed on the market and take the appropriate actions to ensure the safety of patients. As further explained by the authority, the Board shall develop PMS survey protocols and implement the sampling and testing of medical products and health technologies using risk-based approaches. In contrast, the PMS activities shall be implemented annually using a risk-based approach to determine sampling and testing priorities across different medical products in public, private, and unregulated supply chains. According to the guidance, the scope of post-marketing surveillance activities includes, inter alia, reporting the issues related to medical devices, handling complaints, and also special actions are taken to mitigate the risks associated with medical devices, such as removal of certain products from the market.
The authority states that the PMS planning process should include the following steps:
- Protocol Development;
- Planning for sampling;
- Coordination of sampling exercise;
- Validation of the results;
- Regulatory action plans;
- Dissemination of PMS results;
- Follow-up of regulatory actions.
The samples collected as described above should be tested by the applicable standards and specifications. The results of such testing should be submitted to the respective department of the authority.
Sampling and Testing Priorities
The document further describes in detail the aspects related to sampling and testing medical devices in case of safety-related concerns. According to the guidance, the factors to be taken into consideration concerning sampling include, inter alia, the following ones:
- Ongoing monitoring of the products newly placed on the market;
- Sampling and testing the products with relatively high risk;
- Monitoring the products based on various factors;
- Monitoring the quality of healthcare products using a set of specific criteria when the products are being imported;
- Using a sampling plan which determines such aspects as the sampling sites, techniques to be used, as well as the sampling plan;
- Complying with the applicable requirements during the transportation and storage of the samples collected, incline the instructions communicated by the manufacturer, to ensure the characteristics and properties of the product in question are not affected adversely by the factors the product could be subject to during storage and transportation.
- The samples collected should be transported by the transportation and storage requirements provided by the manufacturer. Furthermore, it should be explicitly stated that all the samples are intended for testing purposes only, and should not be made available to customers.
Testing: Key Points
As further described by the authority, the personnel of the Quality Control (QC) laboratory should participate in creating market surveillance plans. In particular, they will be responsible for advising on technical matters related to the tests to be performed, the number of samples needed, and other similar matters, including the development of a sampling form.
When describing the role of QS laboratories, the authority emphasizes the following aspects:
- The laboratory should have all the necessary equipment and staff to be able to conduct testing as prescribed by the appropriate testing protocol.
- The laboratory should also agree on costs based on the number of samples subject to evaluation.
- In the case of several QS laboratories involved in the testing process, all the samples should be divided among them.
- An entity responsible for a medical device subject to the evaluation should enter into the appropriate agreement with the laboratory, addressing all the key points related to the evaluation process.
- The number of samples needed, as well as the scope of testing to be performed, should be determined based on the appropriate testing protocol.
- The QS laboratory is obliged to ensure the confidentiality of the information it receives in the context of testing conducted.
- The laboratory should duly keep all the records related to the testing conducted, and provide them to the authority upon request.
Concerning the testing and the way it should be conducted, the authority outlines the following key points:
- As it was mentioned before, testing should be carried out strictly by the respective testing protocol to ensure the accuracy and reliability of the results.
- The scope of testing depends on the nature of the product in question and its specific features, and also on the goals to be achieved.
- The goals should be also considered when deciding on the specific testing methods and specifications to be applied. The authority additionally emphasizes that the samples of products manufactured by different manufacturers should be subject to testing based on the same approach to ensure the comparability of the results.
In summary, the present guidance provides an overview of the existing regulatory requirements for post-market surveillance, including the ones related to the applicable procedures and sampling process. The document also describes in detail the requirements related to testing and highlights the most important aspects associated thereto.
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