Consultation on Medical Devices Guidance Documents

[Updated on 24 April 2018]

The Medical Devices Branch has conducted industry briefing on 28 Feb 2018 and Public Consultation on the Proposed Amendments to the Health Products (Medical Devices) Regulations from 28 March 2018 to 11 April 2018.

We would like to invite our stakeholder to provide feedback on our guidance documents updated to incorporate changes due to the amendments to the Health Products (Medical Devices) Regulations:

a. GN13 Guidance on the Risk Classification of General Medical devices [pdf]
b. GN14 Guidance on the Risk Classification of In-vitro Diagnostic General Medical devices [pdf]
c. GN21 Guidance on Change Notification for Registered Medical Devices [pdf]
d. GN30 Guidance on Authorisation Route for Import on Consignment Basis [pdf]

The Consultation period for document (a to d above) is from 24 April 2018 to 08 May 2018. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 08 May 2018. Please indicate "MD Guidance Documents feedback" in the email subject header.

 Guidance Feedback Form [xls]

[Updated on 03 May 2018]

e.  GN15 Guidance on Medical Device Product Registration [pdf]
f.   GN16 Guidance on Essential Principles for Safety and Performance of Medical Devices [pdf]
     Annex 2 GN-16 EP Checklist Template [doc]
     Annex 3 GN-16 EP Checklist Template [doc]
g.  GN23 Guidance on Labelling for Medical Devices [pdf]
h.  GN02 Guidance on Licensing for Manufacturers, Importers and Wholesalers of Medical Devices [pdf]
i.   GN33 - GDPMDS  [pdf]

The Consultation period for document (e to i above) is from 03 May 2018 to 17 May 2018. Please email your feedback using the prescribed feedback form by 17 May 2018 to HSA_MD_INFO@hsa.gov.sg. Please indicate "MD Guidance Documents feedback" in the email subject header.

 Guidance Feedback Form [xls]