Home About Qualtech NEWS SINGAPORE: HSA Summarizes Important Updates for Guidance Document on Essential Principles of Safety and Performance of Medical Devices – January 2019
SINGAPORE: HSA Summarizes Important Updates for Guidance Document on Essential Principles of Safety and Performance of Medical Devices – January 2019

January 15, 2019

GN-16 or the Guidance on Essential Principles of Safety and Performance of Medical Devices was put for public consult last May 2018. The comments from the industry stakeholders were incorporated by HSA into the latest GN-16 document which was uploaded in June 2018. The past month, HSA uploaded slides unto their website to share with the stakeholders the changes in the updated GN-16

GN 16 guidance describes the fundamental design and manufacturing requirements for all medical devices. This design and requirements is referred to as “Essential Principles of Safety and Performance (EP)”. This guidance provides the following information to stakeholders:

1. Flexibility to product owners on how they show conformity to EP

2. Standards can be used to reflect conformance to EP

3. Tabular checklist of EPs and corresponding evidence of how the MDs meets the applicable EP is submitted for MD Registration

The revised GN 16 has the following overview of the changes made:

1) Re-ordering, merging, renaming of sections

2) Addition of definitions

3) Updates to phrasing of existing EPs

4) New Eps to clarify existing concepts better and address EPs unique to IVDs

5) Updated EP conformity checklist (EPCC) and the accepted versions

The following diagram shows the summary of the content of the new GN-16. Detailed information can be found in the said document which is downloadable in HSA site:

2 GN16 Important Updates

 

Reference:

GN 16 Guidance on Essential Principles of Safety and Performance of Medical Devices- Key updates

 

 

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Home About Qualtech NEWS SINGAPORE: HSA Summarizes Important Updates for Guidance Document on Essential Principles of Safety and Performance of Medical Devices – January 2019