On July 2025, the Health Sciences Authority (HSA) released a new revision to existing guidance titled GN-09: Guidance on the Component Elements of a Dear Healthcare Professional Letter (DHCPL).
To view the official guidance document, refer to: GN-09: Guidance on the Component Elements of a Dear Healthcare Professional Letter
Key Highlights
New Clause Requirement
This guidance outlines the requirements for drafting a Dear Healthcare Professional letter (DHCPL) or its equivalent incorporating the newly added Clause 2.6: Problem Identified & Description of Health Risk. This clause requires the dealers of medical devices to include details of the health risk and any problems identified. Some of the requirements are as follows:
- any AE reported;
- their seriousness (e.g., hospitalisation, transplantation, fatality, etc);
- the rationale for suspecting a causal relationship or causative factor (e.g., features that are compromised by the device failure, how device failure would manifest clinically);
- whether the event is linked to an “unapproved” indication or “unapproved” condition of use;
- specify what is known about the AE and how likely sensitive populations within the general public (e.g., children or the elderly) are affected;
- indicate how reliable the knowledge is on which the communication is based;
- indicate whether the quality of this knowledge is expected to improve (e.g., through further research) and who is responsible for improving it;
- provide a qualitative description of the uncertainties that may exist in the base of knowledge from which the content of the communication is drawn. Indicate what further steps may reduce these uncertainties;
- provide a qualitative and quantitative description of the estimates of probability; and
- the number of events of interest reported domestically and internationally with estimations of patient exposure.
Implications to Clients
Dealers of Medical Devices who are required to draft Dear Healthcare Professional Letters (DHCPLs) will need to comply with the latest requirements, including the newly added clause on identifying problems and describing associated health risks.
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