MDACS Activities

MDACS Activities

Caption: Data Table
Posting Date Title
13 May 2024 Guidance Notes "Overview of the Medical Device Administrative Control System" (GN-01) has been updated
22 Apr 2024 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
15 Apr 2024 The Medical Device Information System (MDIS) is supporting New Applications for listing Medical Devices and Traders
28 Mar 2024 Introduction of the new Medical Device Information System
28 Mar 2024 The webpage on "Listed Home-use Blood Glucose Meters and Test Strips under MDACS" has been updated.
28 Mar 2024 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
28 Mar 2024 Not including custom-made medical device in the scope of Medical Device Administrative Control System (MDACS)
28 Mar 2024 Announcement of the acceptance of marketing approvals obtained from the Health Sciences Authority (HSA) of Singapore under the Medical Device Administrative Control System (MDACS)
28 Mar 2024 Replacing the term “Make” with “Manufacturer” under the Medical Device Administrative Control System (MDACS)
01 Mar 2024 The Code of Practice "Code of Practice for Listed Distributors of Medical Devices" (COP-05) has been issued.
19 Feb 2024 "Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA)" has been added
01 Feb 2024 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
03 Jan 2024 Technical Reference "Artificial Intelligence Medical Devices (AI-MD)" (TR-008) has been issued
02 Jan 2024 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
01 Jan 2024 Announcement of the acceptance of marketing approvals obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea under the Medical Device Administrative Control System (MDACS)
01 Jan 2024 The Change Application Form (MD105) has been updated
29 Dec 2023 Technical Reference "Software Medical Devices and Cybersecurity" (TR-007) has been issued
29 Dec 2023 The webpage on "Listed Home-use Blood Glucose Meters and Test Strips under MDACS" has been updated.
22 Dec 2023 Technical Reference "Classification of In Vitro Diagnostic Medical Devices (IVDMDs)" (TR-006) has been updated
11 Dec 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
30 Nov 2023 The document "Guidance Notes for Changes of Listed Medical Devices" (GN-10) is issued
27 Nov 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
24 Nov 2023 Department of Health visits to Gerontech & Innovation Expo cum Summit (GIES) 2023
24 Nov 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
10 Nov 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
25 Oct 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
24 Oct 2023 The webpage on "Listed Home-use Blood Glucose Meters and Test Strips under MDACS" has been updated.
18 Oct 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
10 Oct 2023 The webpage on "Listed Home-use Blood Glucose Meters and Test Strips under MDACS" has been updated.
09 Oct 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
26 Sep 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
12 Sep 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
16 Aug 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
07 Aug 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
03 Jul 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
15 Jun 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
14 Jun 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
16 May 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
27 Apr 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
20 Apr 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
03 Apr 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
10 Mar 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
23 Feb 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
15 Feb 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
02 Feb 2023 Upload of Takeover Form for Listed Medical Devices
12 Jan 2023 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
29 Dec 2022 Update of Post-Market Surveillance (PMS) Report Form for Specific Medical Devices
28 Dec 2022 Announcement of the continuance of trial schemes for accepting marketing approvals obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea under the Medical Device Administrative Control System
21 Nov 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
11 Nov 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
31 Oct 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
26 Oct 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
03 Oct 2022 Update of Renewal and Change Application Form for Listed Importers/Distributors
26 Sep 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
02 Sep 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
24 Aug 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
03 Aug 2022 Announcement of the changes to the respective trial schemes for accepting marketing approvals obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea under the Medical Device Administrative Control System (MDACS)
02 Aug 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
22 Jul 2022 Technical Reference TR-004 (Essential Principles of Safety and Performance of Medical Devices) has been updated.
13 Jul 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
06 Jul 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
09 Jun 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
06 Jun 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
01 Jun 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
16 May 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
04 May 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
03 May 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
21 Apr 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
04 Apr 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
28 Mar 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
09 Mar 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
04 Mar 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
03 Mar 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
28 Feb 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
25 Feb 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
22 Feb 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
09 Feb 2022 The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated.
24 Jan 2022 The "Listed Rapid Antigen Tests for COVID-19 under MDACS" have been posted to the website.
05 Jan 2022 Update of Guidance Notes GN-02, GN-06 and related Application Forms
04 Jan 2022 The regularisation of the Expedited Approval Scheme for Class II/III/IV General Medical Device Listing Applications
04 Jan 2022 Announcement of the changes to the respective trial schemes for accepting marketing approvals obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea under the Medical Device Administrative Control System (MDACS)
01 Jan 2022 The disciplinary actions under Medical Device Administrative Control System have been posted to the website.
25 Oct 2021 The current phase of Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications will close by year end
15 Sep 2021 To help identifying if a product is a medical device under the Medical Device Administrative Control System, a online classification programme "Is Your Product A Medical Device?" has been developed and posted for your use.
01 Sep 2021 Revised GN-02 (Guidance Notes for Listing Class II/III/IV Medical Devices), GN-06 (Guidance Notes for Listing In Vitro Diagnostics (IVD) Medical Devices) and associated documents are issued.
25 Jun 2021 Continuance of trial to accept marketing approval obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea for listing application of medical devices under the Medical Device Administrative Control System (MDACS)
28 Dec 2020 Continuance of Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications
24 Dec 2020 Continuance of trial to accept marketing approval obtained from the National Medical Products Administration and the Ministry of Food and Drug Safety of Korea for listing application of medical devices under the Medical Device Administrative Control System (MDACS)
30 Jun 2020 Continuance of Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications
10 Mar 2020 Continuance of trial to accept marketing approval obtained from the Ministry of Food and Drug Safety of Korea for listing application of medical devices under the Medical Device Administrative Control System (MDACS)
22 Jan 2020 Continuance of trial to accept marketing approval obtained from the National Medical Products Administration for listing application of medical devices under the Medical Device Administrative Control System (MDACS)
20 Sep 2019 A trial to accept marketing approval obtained from the Ministry of Food and Drug Safety of Korea for listing application of medical devices under the Medical Device Administrative Control System (MDACS)
20 Aug 2019 Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications
22 Mar 2019 Briefing sessions on Proposed Guidance Notes for Listing of Local Responsible Persons
11 Feb 2019 Notice to local manufacturers in applying for medical device registration in Mainland China
24 Jan 2019 Continuance of trial to accept marketing approval obtained from the National Medical Products Administration for listing application of medical devices under the Medical Device Administrative Control System (MDACS)
23 Jan 2019 Listing of Class B and C In Vitro Diagnostic Medical Devices and Revised GN-06 “Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices”
07 Dec 2018 Draft Guidance Document for Listing Class B, C and D In Vitro Diagnostic Medical Device and Application Form for Comments
09 Oct 2018 To facilitate the classification of an in vitro diagnostic medical device according to its risk level under the Medical Device Administrative Control System, a "Web-based In Vitro Diagnostic Medical Device Classification Programme" has been developed and posted for your use.
31 May 2018 Notice to local manufacturers in applying for medical device registration in Mainland China
31 May 2018 Revised GN-07 (Guidance Notes for Listing of Importers of Medical Devices) and associated document are issued
18 Apr 2018 A trial to accept marketing approval obtained from the China Food and Drug Administration for listing application of medical devices under the Medical Device Administrative Control System (MDACS)
28 Feb 2018 Lists of classified examples of In Vitro Diagnostic Medical Devices (IVDMDs) under the MDACS have just been posted.
09 Jun 2015 The List of Recognised Standards for Medical Devices (RS-01) has been issued. This document provides a good reference for Local Responsible Person (and their manufacturers) to demonstrate the safety and effectiveness of their products in listing applications.
30 Apr 2015 Listing of Distributors of Medical Devices
05 Dec 2014 Two briefing sessions on the draft Guidance Notes for Listing of Distributors were successfully conducted on 25 and 26 Nov. The draft Guidance Notes and Application Form (English version) are now posted for comments.
25 Nov 2014 Briefing sessions on the draft guidance notes for listing of distributors (25 & 26 Nov 2014)
15 May 2014 To facilitate the classification of a general medical device according to its risk level under the Medical Device Administrative Control System, a "Web-based General Medical Device Classification Program" has been developed and posted for your use
11 Jul 2011 Revised GN-02 (Guidance Notes for Listing Class II/III/IV Medical Devices), GN-06 (Guidance Notes for Listing In Vitro Diagnostics (IVD) Medical Devices) and associated documents are issued.
14 Apr 2010 Briefing Sessions on the proposed document GN-09 : Guidance Notes for Listing of Local Responsible Persons (LRPs)
15 Jan 2010 New Guidance Notes GN-00 and Technical Reference TR-003
01 Dec 2009 Listing Class D In Vitro Diagnostic (IVD) Medical Devices
01 Nov 2009 Proposed Document - Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device
19 Jun 2009 Medical Device Administrative Control System uses Asian Medical Device Nomenclature System (AMDNS)
23 Mar 2009 Proposed documents related to listing In Vitro Diagnostic (IVD) Medical Devices
11 Jun 2008 Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System
17 Jul 2007 Listing of Importers of Medical Devices
13 Apr 2007 Conformity Assessment Body Recognized under the MDACS
30 Mar 2007 Proposed Guidance Notes for the Listing of Importers of Medical Devices
23 Mar 2007 Listing of Local Manufacturers of Medical Devices
28 Dec 2006 Proposed Requirements for the Listing of Local Manufacturers
13 Oct 2006 Conformity Assessment Body Recognition Scheme of the Medical Device Administrative Control System
16 Jun 2006 Proposed Documents related to Conformity Assessment under the Medical Device Administrative Control System
14 Nov 2005 Listing of Class III and Class II Medical Devices
01 Sep 2005 New Guidance Notes GN-01, GN-03 and Code of Practice COP-01
16 Aug 2005 Proposed Guidance Notes for the Listing of Class II and Class III Medical Devices under the Medical Device Administrative Control System
09 May 2005 The first medical device listed under the MDACS
26 Nov 2004 Medical Device Administrative Control System
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