Health Sciences Authority (HSA) of Singapore has made minor updates to the guidance document titled ‘GN-09: Guidance on the Component Elements of a Dear Healthcare Professional Letter Revision 3.6’. This guidance document takes effect on 09 May 2022.
It is now a requirement to include the dealer’s contact information to facilitate further information. In addition, an online link is now available as an alternative reporting avenue for healthcare professionals: www.hsa.gov.sg/adverse-events.
Dealers are people who register, manufacture, import, and/or supply wholesale
medical devices locally.
A ‘Dear Healthcare Professional Letter’ is prepared by dealers to communicate risk to medical device users. It is typically used in mandatory reporting of adverse events or used to provide supplementary information to ensure safer and/or effective use of medical devices. This letter should receive clearance from HSA prior to official dissemination. For related information, please refer to guidance document GN-10: Guidance on Medical Device Field Safety Correction Action Revision 3.6 (pub Jan 2020)
If you have any questions about medical device registration and representation in Singapore, please contact us at sales@andamanmed.com