HAS Medical device product registration applications, specifically for in vitro diagnostic devices, should be submitted online through MEDICS, utilizing the CSDT or IMDRF IVD MA ToC.
In this regard, the Singapore HSA(Health Sciences Authority) issued a directive document on the submission of product registration on March 1, 2024.
It details the process for uploading documents related to either the ASEAN Common Submission Dossier Template (CSDT) or the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC).
The documents to be submitted according to CSDT and IMDRF IVD ToC are briefly listed below.
- Letter of Authorization
- List of Configurations
- Proof of reference agency's approval(s)
- Proof of marketing history
- Declaration of no safety issues globally
- Executive Summary
- Essential Principles Checklist and Declaration of conformity
- Device Description
- Design verification and validation
- Proposed Device Labelling
- Clinical evidence
- Risk Analysis
- Manufacturing Information
- QMS
- Manufacturing Process
As such, the guidance for product registration submission to HSA contain registration submission documents and information related to medical devices sold and used in Singapore.
Please refer to the attached file below for more information.
If you have any questions about medical device,
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