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Singapore: Draft for Comments on GN-14: Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Revision 3

The Health Sciences Authority of Singapore (HSA) is soliciting the industry’s feedback on the Draft Guidance Document: GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Revision 3. Updates in the Draft Guidance Document includes:

  1. Inclusion of Standalone software (SaMD) definition per IMDRF;
  2. Clarifications on the classification of control materials and software; and
  3. Clarifications on risk classification rules no. 1 to 5.

Related industries that would like to submit their feedbacks on the draft guidance document may look out on the following timeline and method of submission:

Feedback period: 2 May 2023 to 30 May 2023

Feedback form: GN-14 Guidance Feedback Form 

Feedback method: Email to HSA at HSA_MD_INFO@hsa.gov.sg with subject header “Feedback on GN 14′

Draft guidance: Please refer to this link

 

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