Singapore HSA has recently announced possible changes to the guidance documents GN-17 and GN-18. These changes are currently opened for consults and are not final.
GN-17 specifies the Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT while GN-18 refers to the guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic (IVD) Medical Devices using the ASEAN CSDT. On top of updating the layout to be more reader friendly and interactive, HSA has released updates on both GN-17 and GN-18 which involve:
Instructions for Use;
Safety and performance related information;
History on commercial marketing;
Reference to similar and/or predicate medical devices;
Specific to GN-17: Material safety; and
Specific to GN-18: Electrical Safety & Electromagnetic Compatibility.
HSA has also released drafts on product registration submission guides for increased convenience and clarity while submitting an online application via MEDICS. Two guides were released, one for general medical devices while the other for IVD medical devices for ASEAN CSDT and IMDRF ToC based submissions.
Additionally, HSA has released updates on GN-16 Guidance on Essential Principles of Safety and Performance (EP) of Medical Devices to align more closely to the IMDRF EP guidance as well as to reflect the advancements in medical device technology. The updated guidance will help ensure greater clarity, allowing product owners to show closer conformity to EP when submitting applications for medical device registrations. Main changes to the regulations include:
Establishing a risk management system that is iterative and kept up to date;
Characteristics, performances and safety maintenance of medical devices during transport, storage and shelf-life;
New section on clinical evaluation for all medical devices;
Greater emphasis on sterility and packaging of medical devices;
New section on software, including standalone software or mobile applications;
Updated requirements for labeling and instructions for use; and
Updated requirements for medical devices incorporating materials of biological origins.
For more information on the updated regulations (GN-16/ GN-17/ GN-18) and the e-submission guides, check out the following link:
-Regulatory sharing on 23 Nov 2018
For ARQon e-submission CSDT guides, please contact ARQon.
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