Home About Qualtech NEWS SINGAPORE: HSA to Revamp Existing Product Registration Submission Guidance – January 2019
SINGAPORE: HSA to Revamp Existing Product Registration Submission Guidance – January 2019

January 15, 2019

HSA continues to strive in improving current medical device guidelines for stakeholders to register and sell their devices into Singapore with ease. 2018 marked the start of this goal by revising majority of the guidance documents. This past month, the revision of guidance documents continue as HSA shared tentative changes on the preparation of submission dossier for both general devices and In-Vitro devices.

Currently, HSA has uploaded the draft documents for the following guidance for public consultation:

GN 17: Guidance on Preparation 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

The present GN-17 and GN-18 documents seemed too technical, lack of clarity and complicated according to the industry feedbacks received by HSA. The regulatory body responded by attempting to remove these roadblocks experience by industry stakeholders.

HSA aims that the proposed guidance documents are simple, concise yet detailed enough for the industry stakeholders to use. In summary, the following are the highlights of the change for these two guidance:

1.  Guidance document offers simple and reader-friendly layout.

2. Guidance document aims to have greater clarity by having bite-sized information

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. 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

In addition, the current guidance documents will be converted into Technical reference documents. These technical reference documents will provide in depth understanding of the documentary requirements for the revamped GN-17 and GN 18:

(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

HSA is planning a major revision on GN-17 and GN-18 in order to simplify the contents to industry. Currently the proposed guidance documents are for public consultation. Qualtech and partner industry stakeholders are encouraged to wait for the official HSA implementation date of these documents. 

 

Reference:

Preparation of Medical Device Registration Dossier - Updates to guidance documents

 

 

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Home About Qualtech NEWS SINGAPORE: HSA to Revamp Existing Product Registration Submission Guidance – January 2019