The new article describes in detail the responsibilities of the parties involved in operations with medical devices in terms of post-marketing surveillance.
The Ministry of Health of Kenya has published a guidance document dedicated to the post-marketing surveillance of medical products and health technologies. The document is intended to provide additional clarifications regarding the existing regulatory framework, as well as recommendations to be taken into consideration to ensure compliance thereto. However, provisions of the guidance are non-binding, nor are intended to impose new rules or obligations. The guidance describes in detail the existing post-marketing surveillance (PMS) system and its core elements.
According to the document, there are two main approaches to post-marketing surveillance in the country, namely:
- Reactive post-marketing surveillance – conducted through evaluation of feedback from stakeholders, investigation of product-related market complaints and reports of poor-quality medical products, and implementation of regulatory actions. The authority also mentions that this could include an unannounced sampling.
- Proactive post-market surveillance – this approach entails systematic, scientific, and structured quality surveys that are based on a study protocol.
The guidance further provides a flowchart illustrating the way the aforementioned approaches should be applied, including the steps to be taken. According to the flowchart, the overall process includes, inter alia, such steps as product market authorization review (intended to identify whether the product is duly registered to be allowed for marketing and use in the country), or sample testing.
Roles and Responsibilities: Key Points
As further explained in the document, the efficient post-marketing surveillance process requires the participation of all the parties involved in operations with medical devices including but not limited to healthcare professionals, medical device manufacturers, testing laboratories, and others. The guidance outlines the main responsibilities of the parties involved and highlights the key points associated thereto.
- First of all, patients are encouraged to notify the authority about any issues with healthcare products they’ve faced;
- Furthermore, patients may provide samples of suspicious products to the authority for further investigation;
- Apart from that patients should strictly follow the appropriate instructions regarding the handling and storage of healthcare products as communicated by the manufacturer, and also the Good Practice Guidelines;
- Any deviations from the aforementioned procedures should be duly reported;
- Participate in regulatory actions, such as recalls;
- Identify suspicious products and submit reports via the electronic system.
- Healthcare providers
- Notify the authority about any deviations in handling and storage requirements;
- Participate in regulatory actions;
- Notify the authority about the suspicious products identified.
- Market Authorization Holder (MAH), a party responsible for a medical device duly registered in the country and, consequently, allowed for marketing and use in Kenya
- Ensuring the quality, safety, and effectiveness of the products made available;
- Sharing post-marketing surveillance data they have, as well as any other reports related to the safety and effectiveness of the products they are responsible for;
- Actively participate in regulatory actions related to the products they are responsible for, including sharing costs of such actions;
- Collaborate with the regulating authority by providing the information requested by the latter;
- Follow the appropriate reporting requirements;
- Duly notify the authority about reportable issues associated with medical devices they are responsible for by the applicable timeframe;
- Develop and implement an emergency plan prescribing the way the actions should be taken in case of issues with the products already placed on the market (e.g., recalls or withdrawals);
- Take actions to ensure the effectiveness of withdrawals and recalls;
- Inform the authority about any issues with the products and respective regulatory actions taken on other markets where the products are also available (such notification should be submitted within 7 days from the date the authorization holder became aware of such issue).
- Medical device manufacturers
- Follow the regulations on investigations of quality defects, including in terms of internal investigations;
- Collaborate with the authority by providing the data and reports as required by the applicable regulations on investigations;
- Submit the root cause investigation reports within 2 weeks from the date the appropriate request from the authority has been received;
- Notify the authority about any non-compliances identified about the products that are already allowed for marketing and use in the country;
- Implement the directives issued by the authority.
- Quality Control Laboratories
- Conduct testing of healthcare products upon request;
- Develop and apply testing methods based on the respective standards and regulatory requirements;
- Issue certificates of analysis;
- Take part in the review of post-marketing surveillance protocols.
The guidance further describes in detail the spheres of responsibilities of other parties involved in operations with medical devices including different organizations and regulatory bodies, such as research institutions or development partners. The document pays special attention to the responsibilities of the Pharmacy and Poisons Board, the Ministry’s department responsible for post-marketing surveillance regarding the healthcare products allowed for marketing and use in the country. According to the guidance, the Board shall:
- Receive and review the reports regarding healthcare products to be submitted by other parties involved, including healthcare professionals, patients, or marketing authorization holders;
- Conduct investigations regarding the suspicious products;
- Implement the regulatory actions necessary to ensure the quality of the products used in the country, and also the safety of patients;
- Provide feedback to the reports within 7 days from the date the investigation has been completed;
- Ensure the effectiveness of all the operations with the information;
- Develop and implement the mechanisms ensuring the efficient cooperation of all the parties involved in post-marketing activities;
- Organize and conduct training in the sphere of post-marketing surveillance;
- Ensure that all the important information regarding PMS activities is duly communicated to the parties involved in operations with medical devices;
- Notify the respective international organizations;
- Conduct ongoing analysis of quality data.
The other parties covered by the guidance include, inter alia, the following ones:
- The National PV/PMS Technical Working Group is responsible for providing technical guidelines regarding post-marketing surveillance and the way it should be performed, participating in further development of PMS techniques and strategies, and also providing technical assistance and advice on related technical matters.
- Central Procurement Agencies engaged in sharing post-marketing quarterly surveillance data.
In summary, the present guidance outlines the most important aspects related to post-marketing surveillance and the responsibilities of the parties involved in operations with medical devices. The document defines the responsibilities of the regulating authority, as well as of the medical device manufacturers and other stakeholders.
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