Home About Qualtech NEWS SINGAPORE: HSA has Released Four (4) Medical Device Updates for the Month of January – January 2019
SINGAPORE: HSA has Released Four (4) Medical Device Updates for the Month of January – January 2019

January 16 2019

This month’s updates include the "Medical Devices Registration Dossier Guideline ", “Update the Guidance Document on Essential Principles of Safety and Performance”, “Revamp Existing Product Registration Submission Guidance” among others. All information you need to know have been summed up in a nutshell.

1.       HSA Shares Plans on Revising Medical Device Registration Dossier Guidelines

As part of enhancing service offered and making registration easy and accessible to industry stakeholders, HSA has proposed changes in the preparation of Medical Device Registration Dossier which is applicable to General Devices and In-Vitro Devices.

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2.       HSA Summarizes Important Updates for Guidance Document on Essential Principles of Safety and Performance of Medical Devices

ast year, HSA had requested for public opinion on the draft Guidance Document on Essential Principles of Safety and Performance of Medical Devices (GN-16). Recently, HSA has summarized and shared with the stakeholders the changes in the updated GN-16.

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3.       HSA to Revamp Existing Product Registration Submission Guidance

HSA has released new draft guidance documents in an effort to ease product registration submission procedure. HSA aims that the proposed guidance documents are simple, concise yet detailed enough for the industry stakeholders to use.

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4.       HSA Drafts Guidance Document to cater for ASEAN CSDT and IMDRF ToC based submissions in MEDICS

In line with its aim to facilitate an easier registration process to stakeholders, HSA drafts a comprehensive guideline for the submission of product registration dossier via MEDICS. This guide matches the appropriate modules in MEDICS with the corresponding sections of CSDT or IMDRF ToC dossier in order to simplify the uploading process.

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Home About Qualtech NEWS SINGAPORE: HSA has Released Four (4) Medical Device Updates for the Month of January – January 2019