top of page

Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD

On 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions for therapeutic products held from 2 May 2023 to 12 June 2023.

HSA intends to introduce eCTD to enable full e-submissions, thereby reducing the need for the submission of documents using storage media such as CD/DVD ROMs.

eCTD is an internationally recognized standard format for electronic information transfer to health authorities. During the consultation, the industry will have the opportunity to provide feedback and comments on the eCTD specification package.

With the assistance of its appointed vendor (Lorenz Life Sciences group and partners), HSA is developing the eCTD system (ICH eCTD version 3.2.2) in Singapore. Initially, the HSA will accept new drug applications, generic drug applications as well as their respective Drug Master Files (DMFs), with a phased approach and a voluntary use of eCTD for dossier submissions.

The HSA will publish the final eCTD specification package as well as a summary of changes based on feedback received during the consultation. Singapore plans to implement eCTD in Q4 2024.

Click this LINK to download the eCTD specification package.

Similarly, The Medical Devices Cluster (MDC) has released a draft update "Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices for Stakeholders" for consultation that assists product owners in risk classification of in vitro diagnostic (IVD) medical devices using the appropriate risk classification rules.


bottom of page