Regulatory Updates
Regulatory Sharing at SMF (23 November 2018)
Audiences
Healthcare professional
Industry member
Product type
Medical devices
22 November 2018
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[Updated on 22 November 2018]
The Medical Devices Cluster will be sharing on some of our on-going updates to our Guidance documents this year.
We have updated our guidance document on the Essential Principles of Safety and Performance for Medical Devices in June 2018 after stakeholders’ consultation. We are now working on updates to the guidance documents on Preparation of a Medical Device Registration Dossier.
We will be sharing some of these updates during the SMF MTIG regulatory session on 23 November 2018.
The presentation slides are attached below:
Preparation of Medical Device Registration Dossier - Updates to guidance documents [PDF, 1511 KB]
We would like to invite our stakeholders to provide feedback on our guidance documents on Preparation of a Medical Device Registration Dossier.
a. GN-17 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT (for consult) [pdf]
b. GN-18 Guidance on Preparation of a Product Registration Submission for In-Vitro Diagnostic Medical Devices using the ASEAN CSDT (for consult) [pdf]
c. E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS (for consult) [pdf]
d. E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS (for consult) [pdf]
Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 24 December 2018. Please indicate "MD Guidance Documents feedback" in the email subject header.
Guidance feedback form [xls]