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Health Sciences Authority
Regulatory Updates

Consultation on Medical Devices Risk Classification Guidances

Audiences

Healthcare professional

Industry member

Product type

Medical devices

12 April 2013

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

[Updated on 12 April 2013] The Medical Device Branch (MDB) would like to invite our stakeholders to provide feedback on our guidance documents on the risk classification of medical devices:

1) GN-13 Guidance on the Risk Classification of General Medical Devices

For Consultation GN-13 Guidance on the Risk Classification of General Medical Devices [pdf]

GN-13 Risk Classification of General Medical Devices Feedback Template [xls]

2) GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices

For Consultation GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices [pdf]

GN-14 Risk Classification of IVD Medical Devices Feedback Template [xls]

Please provide your feedback, proposals and reasons using the Excel forms. This information will facilitate in our collation of your suggestions and review.

Please submit your comments in the prescribed format via email to hsa_md_info@hsa.gov.sg before 12 May 2013. Please include the subject header “Risk classification feedback” for the email.

Your input is highly valued and we thank you in advance for your constructive feedback.

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