Home About Qualtech NEWS SINGAPORE: HSA Shares Plans on Revising Medical Device Registration Dossier Guidelines – January 2019
SINGAPORE: HSA Shares Plans on Revising Medical Device Registration Dossier Guidelines – January 2019

January 15, 2019

As part of HSA’s continuing efforts in making the registration easy and accessible to industry stakeholders, the Singapore regulatory body shared their proposed changes in the preparation of Medical Device Registration Dossier which is applicable to General Devices and In-Vitro Devices

HSA will stage the revision in the Preparation of dossier guidelines in three parts:

1) Revision of existing guidance documents which pertains to submission requirements

2) Introduction of Technical Reference Documents

3) Revamp of Product Registration Submission Guides

Revision of existing guidance documents which pertains to submission requirements

HSA made changes to the following existing guidance documents:

A.) GN 17: Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT

B.) GN18: Guidance on Preparation of a Product Registration Submission for In-Vitro Diagnostic Medical Devices using the ASEAN CSDT

A summary of the changes made to these documents is as follows:

1.  Document offers simple and reader-friendly layout (GN 17 and 18).

2.  Document aims to have greater clarity by having bite-sized information (GN 17 and 18).

3.  Interactive tools can be found within the document to improve access to information (GN 17 and 18). Example of interactive tools are links within the documents that refer to  the following:

a.      Other guidance documents

b.      Templates

c.      Subsections within the document.

4. Document includes updated information regarding the following requirements:

a.   GN 17

• Materials

b.  GN 18

• Electrical Safety and Electromagnetic Compatibility

• Other Evidence

c.  GN 17 and 18

• Instructions for Use

• Important Safety and Performance Related Information

• Commercial Marketing History

• Stability Studies

• Cybersecurity

• Reference and comparison to similar and/or previous generations of the device

Introduction of Technical Reference Documents

HSA received comments from the industry that the current GN-17 and GN-18 documents are  too technical. HSA plans to convert these old documents as technical reference documents which can be tools for stakeholders to understand more of the requirements. The planned conversion of the old documents to technical documents can be seen in the following table:

(From) Old Guidance Document

(To) Technical Reference Document

GN 17: Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT

TR-01: Contents of a Product Registration

Submission for General Medical Devices using the ASEAN CSDT

GN18: Guidance on Preparation of a Product Registration Submission for In-Vitro Diagnostic Medical Devices using the ASEAN CSDT

TR-02: Contents of a Product Registration

Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT

The new technical reference documents will also include the following information as per proposed GN-17 and GN-18 changes:

A.      Open FSCAs

B.      Commercial Marketing History

C.      Cybersecurity

D.      Materials

E.       Electrical and electromagnetic compatibility

F.       Evidence for non-IVD accessories

G.     Stability studies

Revamp of Product Registration Submission Guides

HSA database showed large percentage of manufacturers with are from US or EU region. HSA mentioned that these manufacturers from these region may have technical file prepared according to IMDRF ToC format. Using this information, HSA will be accepting two formats of submission dossier in the future:

1.  ASEAN CSDT format

2.  IMDRF ToC format

a. Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC)

b. In-vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC)

The challenge in implementing this for HSA is designing the existing MEDIC modules in accepting either formats when stakeholders do their online submission. Due to this, HSA also launched new guidance for the E-submission of files in MEDICS:

A. E‐Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based submissions in MEDICS

B. E‐Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS

Both of these guidance specifies the modules in MEDICS in uploading the different sections of the two formats. These documents also include guidance on submitting responses to input request queries.

HSA will be full implementing the changes in how stakeholders will they prepare the submission and how will they do it in MEDICS. Currently the proposed guidances are currently for public consult before HSA finalize it for implementation. HAS aims to provide easy flow of dossier preparation and submission for stakeholders to register and sell their products in SG with ease.

 

Reference:

Preparation of Medical Device Registration Dossier: Updates to guidance documents

 

 

Follow us here and stay updated on all latest happenings in Asia medical device market and more:

Facebook iconLinkedin iconTwitter icon

 

 
Home About Qualtech NEWS SINGAPORE: HSA Shares Plans on Revising Medical Device Registration Dossier Guidelines – January 2019