The new article describes in detail certain specific aspects related to post-market surveillance – in particular, the way the authority is going to communicate important safety-related information to stakeholders.
The Pharmacy and Points Board of the Kenyan Ministry of Health has published a guidance document dedicated to the post-marketing surveillance of medical products and health technologies. The document provides additional clarifications regarding the applicable regulatory requirements for post-marketing activities to be conducted concerning healthcare products, including medical devices, that are allowed for marketing and use in the country. The guidance provides recommendations to be followed by medical device manufacturers, importers, healthcare institutions, and other parties involved in operations with medical devices to ensure the safety of patients. It is important to mention that provisions of the guidance are non-binding, so in case of any discrepancies with the respective provisions of the underlying legislation the latter should prevail. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should it be reasonably necessary to reflect the changes to the applicable regulations.
Communication: Key Points
The guidance addresses, inter alia, the aspects related to communication of market surveillance activities. According to the document, the purpose of such communication is to provide timely, meaningful, relevant, and accurate information, in clear and understandable terms targeted to a specific audience for minimizing the public health risk or health hazard that may be posed by quality defects medical products. The authority intends to communicate such information concerning the quality, safety, and effectiveness of medical devices placed on the market by the respective internal procedures and policies. In particular, such information will be published on the special portal dedicated to the regulatory actions.
The aforementioned communications are intended for all the parties involved in operations with medical devices including, inter alia, patients, healthcare professionals, and suppliers. Apart from that, important safety-related information will be published in the media to ensure public awareness.
The document further describes the content of quality-related communication. According to the guidance, it should contain:
- Important new information on the quality of any authorized [healthcare product] which has an impact on risk-benefit balance under any conditions of use;
- Any recommendations to healthcare professionals and patients on how to deal with the quality concern;
- When applicable, a statement on the agreement between the [authorization holder] and the Board on the information on the quality of the medical product;
- Any additional information about the use of the [healthcare product] and other data that may be relevant for tailoring the message to the targeted audience;
- In cases of Class I recalls, the healthcare providers and the public will be advised on the recall strategy and the timelines;
- A list of literature references, when relevant or a reference where more detailed information can be found, and any other background information considered relevant;
- A reminder of the need to report suspected medical products and health technology by a reporting system for suspected poor-quality medical products.
The document also describes specific communication channels and tools the authority may use to reach out to the target audience. According to the guidance, the information outlined hereinabove could be communicated directly to healthcare professionals, by issuing respective materials, via press communication or website. The authority may also use social media or provide information in response to inquiries and requests. Additional ways of communication include publications in scientific journals and similar sources.
Rapid Alert System
According to the document, the authority intends to develop and implement a system designed to ensure a timely, proportionate, accurate, and consistent response to health events arising from sub-standard and falsified healthcare products which represent a significant threat to the health and safety of the public. The said system will be used to communicate vitally important information which should be provided without delay. It is stated that the information to be communicated via the said system could initially derive from various sources (e.g., healthcare providers, authorization holders, authorities, etc.). The system is intended to ensure public health protection by establishing an efficient way of communicating critical safety-related information to all the parties involved. The authority mentions that the system could be also used to communicate information regarding class I recalls or issues associated with investigational products undergoing clinical trials.
The information to be communicated via the rapid alert system could be related to:
- Quality defects and medical device deficiencies identified by the Board that require urgent regulatory actions e.g., class I recalls, product withdrawal, product quarantine;
- Quality defects for medical products of high public health impact;
- WHO alerts of finished products and Active Pharmaceutical Ingredients (API) regarding safety issues;
- Follow-up actions on a rapid alert notification.
The document also describes the responsibilities of the parties involved in the process of communicating important information to stakeholders, as well as the timelines and channels to be used. For instance, it is stated that the information related to class I recalls should be communicated via telephone and SMS/emails within 24 hours. Such information should be also published in printed media. The timeline for class II recalls is less strict – such information could be communicated within 72 hours. The authority also states that the rapid alert system should not be used for communicating information on class III recalls.
Irrespective of the communication channels used, all the important safety- and quality-related information will be published on the authority’s website without delay. Should the information communicated via any of the means described hereinabove require the specific actions to be taken by the parties involved in operations with medical devices, such parties should duly inform the authority about the actions taken by the general reporting requirements applicable for such cases.
In summary, the present guidance describes in detail the approach to be applied by the authority when communicating vitally important information related to the quality and safety of healthcare products allowed for marketing and use in Kenya. The document provides clarifications regarding the specific channels the authority intends to use to make sure such information is duly communicated to healthcare professionals, patients, and other parties involved in operations with medical devices, and the appropriate actions are taken.
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