Home About Qualtech NEWS SINGAPORE: HSA Drafts Guidance Document to cater for ASEAN CSDT and IMDRF ToC based submissions in MEDICS – January 2019
SINGAPORE: HSA Drafts Guidance Document to cater for ASEAN CSDT and IMDRF ToC based submissions in MEDICS – January 2019

January 16, 2019

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.

HSA has provided guidelines for the (1) initial submissions and (2) submission of responses to input requests via MEDICS.

1) MEDICS Application form for Initial Submissions

All Technical Dossiers and supporting documents shall be submitted under 'Dossier & Supporting Documents' section of the MEDICS application form. It comprises of several modules where specific documents should be uploaded.

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Figure 1. Overview of MEDICS Application form.

Photo Taken from: Health Sciences Authority PRODUCT REGISTRATION SUBMISSION GUIDE E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS (Dec 2018)

The MEDICS application form lists out the various modules in the Dossier and Supporting Documents section, along with a brief description of the expected documents to be uploaded in each module.

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Figure 2. Modules in the MEDICS Application form

Photo Taken from: Health Sciences Authority PRODUCT REGISTRATION SUBMISSION GUIDE E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS (Dec 2018)

In order to facilitate a more efficient review of the pre-market application, applicants should make sure that the relevant sections of the dossier and other supporting documents are uploaded under the correct module (e.g., Free Sales Certificate should be uploaded under Proof of Reference Agency's Approval module). Dossiers may come in various formats (CSDT and IMDRF ToC). The specific modules (in MEDICS) where respective sections of CSDT and IMDRF ToC should be uploaded are summarized in the following table:

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*Note: Documents that do not fit into any of the modules in MEDICS shall be uploaded under “Other document, please specify” e.g. HSA‐specific information, input request response document

 

The provisions under this guideline are still subject to public consultation. HSA hopes that this new guidance be of help to both applicants and evaluators alike in fast tracking the review process of all applications, thereby facilitating a smooth registration process and enabling a quick launch of quality medical device products across country.

 

Reference:

E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS

 

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Home About Qualtech NEWS SINGAPORE: HSA Drafts Guidance Document to cater for ASEAN CSDT and IMDRF ToC based submissions in MEDICS – January 2019