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The Health Sciences Authority of Singapore (HSA) is soliciting the industry’s feedback on the Draft Guidance Document: GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Revision 3. Updates in the Draft Guidance Document includes:
- Inclusion of Standalone software (SaMD) definition per IMDRF;
- Clarifications on the classification of control materials and software; and
- 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Related industries that would like to submit their feedbacks on the draft guidance document may look out on the following timeline and method of submission: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Draft guidance: Please refer to this link
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