15 Nov 2024 |
15 Nov 2024Delegates from the Department of Health attend Governance of Medical AI Conference held by HKU Centre for Medical Ethics and Law |
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15 Nov 2024 |
15 Nov 2024Various Technical References have been updated |
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30 Sep 2024 |
30 Sep 2024New arrangement of Processing of Renewal Application of Listed Medical Device |
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17 Sep 2024 |
17 Sep 2024The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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15 Aug 2024 |
15 Aug 2024The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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14 Aug 2024 |
14 Aug 2024Technical Reference "Classification of General Medical Devices" (TR-003) has been updated |
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08 Aug 2024 |
08 Aug 2024Various Guidance Notes and Code of Practice have been updated |
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26 Jul 2024 |
26 Jul 2024The scope of “Expedited Approval Scheme for Medical Device Listing Applications” will extend to include listing application of Class B/C/D In Vitro Diagnostic Medical Device |
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19 Jul 2024 |
19 Jul 2024Guidance Notes "Guidance Notes for Changes of Listed Medical Devices" (GN-10) has been updated |
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16 Jul 2024 |
16 Jul 2024Technical Reference "Classification of In Vitro Diagnostic Medical Devices (IVDMDs)" (TR-006) has been updated |
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11 Jul 2024 |
11 Jul 2024Key dates of rollout of e-services of Medical Device Information System (MDIS) have been updated |
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08 Jul 2024 |
08 Jul 2024The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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13 May 2024 |
13 May 2024Guidance Notes "Overview of the Medical Device Administrative Control System" (GN-01) has been updated |
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22 Apr 2024 |
22 Apr 2024The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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15 Apr 2024 |
15 Apr 2024The Medical Device Information System (MDIS) is supporting New Applications for listing Medical Devices and Traders |
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28 Mar 2024 |
28 Mar 2024Introduction of the new Medical Device Information System |
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28 Mar 2024 |
28 Mar 2024The webpage on "Listed Home-use Blood Glucose Meters and Test Strips under MDACS" has been updated. |
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28 Mar 2024 |
28 Mar 2024The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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28 Mar 2024 |
28 Mar 2024Not including custom-made medical device in the scope of Medical Device Administrative Control System (MDACS) |
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28 Mar 2024 |
28 Mar 2024Announcement of the acceptance of marketing approvals obtained from the Health Sciences Authority (HSA) of Singapore under the Medical Device Administrative Control System (MDACS) |
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28 Mar 2024 |
28 Mar 2024Replacing the term “Make” with “Manufacturer” under the Medical Device Administrative Control System (MDACS) |
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01 Mar 2024 |
01 Mar 2024The Code of Practice "Code of Practice for Listed Distributors of Medical Devices" (COP-05) has been issued. |
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19 Feb 2024 |
19 Feb 2024"Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA)" has been added |
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01 Feb 2024 |
01 Feb 2024The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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03 Jan 2024 |
03 Jan 2024Technical Reference "Artificial Intelligence Medical Devices (AI-MD)" (TR-008) has been issued |
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02 Jan 2024 |
02 Jan 2024The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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01 Jan 2024 |
01 Jan 2024Announcement 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) |
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01 Jan 2024 |
01 Jan 2024The Change Application Form (MD105) has been updated |
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29 Dec 2023 |
29 Dec 2023Technical Reference "Software Medical Devices and Cybersecurity" (TR-007) has been issued |
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29 Dec 2023 |
29 Dec 2023The webpage on "Listed Home-use Blood Glucose Meters and Test Strips under MDACS" has been updated. |
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22 Dec 2023 |
22 Dec 2023Technical Reference "Classification of In Vitro Diagnostic Medical Devices (IVDMDs)" (TR-006) has been updated |
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11 Dec 2023 |
11 Dec 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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30 Nov 2023 |
30 Nov 2023The document "Guidance Notes for Changes of Listed Medical Devices" (GN-10) is issued |
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27 Nov 2023 |
27 Nov 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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24 Nov 2023 |
24 Nov 2023Department of Health visits to Gerontech & Innovation Expo cum Summit (GIES) 2023 |
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24 Nov 2023 |
24 Nov 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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10 Nov 2023 |
10 Nov 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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25 Oct 2023 |
25 Oct 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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24 Oct 2023 |
24 Oct 2023The webpage on "Listed Home-use Blood Glucose Meters and Test Strips under MDACS" has been updated. |
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18 Oct 2023 |
18 Oct 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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10 Oct 2023 |
10 Oct 2023The webpage on "Listed Home-use Blood Glucose Meters and Test Strips under MDACS" has been updated. |
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09 Oct 2023 |
09 Oct 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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26 Sep 2023 |
26 Sep 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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12 Sep 2023 |
12 Sep 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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16 Aug 2023 |
16 Aug 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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07 Aug 2023 |
07 Aug 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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03 Jul 2023 |
03 Jul 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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15 Jun 2023 |
15 Jun 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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14 Jun 2023 |
14 Jun 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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16 May 2023 |
16 May 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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27 Apr 2023 |
27 Apr 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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20 Apr 2023 |
20 Apr 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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03 Apr 2023 |
03 Apr 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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10 Mar 2023 |
10 Mar 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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23 Feb 2023 |
23 Feb 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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15 Feb 2023 |
15 Feb 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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02 Feb 2023 |
02 Feb 2023Upload of Takeover Form for Listed Medical Devices |
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12 Jan 2023 |
12 Jan 2023The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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29 Dec 2022 |
29 Dec 2022Update of Post-Market Surveillance (PMS) Report Form for Specific Medical Devices |
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28 Dec 2022 |
28 Dec 2022Announcement 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 |
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21 Nov 2022 |
21 Nov 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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11 Nov 2022 |
11 Nov 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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31 Oct 2022 |
31 Oct 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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26 Oct 2022 |
26 Oct 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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03 Oct 2022 |
03 Oct 2022Update of Renewal and Change Application Form for Listed Importers/Distributors |
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26 Sep 2022 |
26 Sep 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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02 Sep 2022 |
02 Sep 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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24 Aug 2022 |
24 Aug 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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03 Aug 2022 |
03 Aug 2022Announcement 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) |
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02 Aug 2022 |
02 Aug 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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22 Jul 2022 |
22 Jul 2022Technical Reference TR-004 (Essential Principles of Safety and Performance of Medical Devices) has been updated. |
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13 Jul 2022 |
13 Jul 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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06 Jul 2022 |
06 Jul 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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09 Jun 2022 |
09 Jun 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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06 Jun 2022 |
06 Jun 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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01 Jun 2022 |
01 Jun 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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16 May 2022 |
16 May 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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04 May 2022 |
04 May 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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03 May 2022 |
03 May 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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21 Apr 2022 |
21 Apr 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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04 Apr 2022 |
04 Apr 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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28 Mar 2022 |
28 Mar 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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09 Mar 2022 |
09 Mar 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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04 Mar 2022 |
04 Mar 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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03 Mar 2022 |
03 Mar 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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28 Feb 2022 |
28 Feb 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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25 Feb 2022 |
25 Feb 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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22 Feb 2022 |
22 Feb 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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09 Feb 2022 |
09 Feb 2022The webpage on "Listed Rapid Antigen Tests for COVID-19 under MDACS" has been updated. |
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24 Jan 2022 |
24 Jan 2022The "Listed Rapid Antigen Tests for COVID-19 under MDACS" have been posted to the website. |
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05 Jan 2022 |
05 Jan 2022Update of Guidance Notes GN-02, GN-06 and related Application Forms |
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04 Jan 2022 |
04 Jan 2022The regularisation of the Expedited Approval Scheme for Class II/III/IV General Medical Device Listing Applications |
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04 Jan 2022 |
04 Jan 2022Announcement 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) |
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01 Jan 2022 |
01 Jan 2022The disciplinary actions under Medical Device Administrative Control System have been posted to the website. |
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25 Oct 2021 |
25 Oct 2021The current phase of Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications will close by year end |
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15 Sep 2021 |
15 Sep 2021To 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. |
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01 Sep 2021 |
01 Sep 2021Revised 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. |
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25 Jun 2021 |
25 Jun 2021Continuance 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) |
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28 Dec 2020 |
28 Dec 2020Continuance of Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications |
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24 Dec 2020 |
24 Dec 2020Continuance 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) |
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30 Jun 2020 |
30 Jun 2020Continuance of Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications |
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10 Mar 2020 |
10 Mar 2020Continuance 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) |
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22 Jan 2020 |
22 Jan 2020Continuance 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) |
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20 Sep 2019 |
20 Sep 2019A 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) |
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20 Aug 2019 |
20 Aug 2019Trial Scheme for Expedited Approval of Class II/III/IV General Medical Device Listing Applications |
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22 Mar 2019 |
22 Mar 2019Briefing sessions on Proposed Guidance Notes for Listing of Local Responsible Persons |
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11 Feb 2019 |
11 Feb 2019Notice to local manufacturers in applying for medical device registration in Mainland China |
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24 Jan 2019 |
24 Jan 2019Continuance 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) |
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23 Jan 2019 |
23 Jan 2019Listing 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” |
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07 Dec 2018 |
07 Dec 2018Draft Guidance Document for Listing Class B, C and D In Vitro Diagnostic Medical Device and Application Form for Comments |
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09 Oct 2018 |
09 Oct 2018To 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. |
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31 May 2018 |
31 May 2018Notice to local manufacturers in applying for medical device registration in Mainland China |
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31 May 2018 |
31 May 2018Revised GN-07 (Guidance Notes for Listing of Importers of Medical Devices) and associated document are issued |
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18 Apr 2018 |
18 Apr 2018A 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) |
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28 Feb 2018 |
28 Feb 2018Lists of classified examples of In Vitro Diagnostic Medical Devices (IVDMDs) under the MDACS have just been posted. |
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09 Jun 2015 |
09 Jun 2015The 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. |
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30 Apr 2015 |
30 Apr 2015Listing of Distributors of Medical Devices |
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05 Dec 2014 |
05 Dec 2014Two 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. |
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25 Nov 2014 |
25 Nov 2014Briefing sessions on the draft guidance notes for listing of distributors (25 & 26 Nov 2014) |
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15 May 2014 |
15 May 2014To 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 |
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11 Jul 2011 |
11 Jul 2011Revised 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. |
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14 Apr 2010 |
14 Apr 2010Briefing Sessions on the proposed document GN-09 : Guidance Notes for Listing of Local Responsible Persons (LRPs) |
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15 Jan 2010 |
15 Jan 2010New Guidance Notes GN-00 and Technical Reference TR-003 |
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01 Dec 2009 |
01 Dec 2009Listing Class D In Vitro Diagnostic (IVD) Medical Devices |
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01 Nov 2009 |
01 Nov 2009Proposed Document - Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device |
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19 Jun 2009 |
19 Jun 2009Medical Device Administrative Control System uses Asian Medical Device Nomenclature System (AMDNS) |
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23 Mar 2009 |
23 Mar 2009Proposed documents related to listing In Vitro Diagnostic (IVD) Medical Devices |
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11 Jun 2008 |
11 Jun 2008Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System |
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17 Jul 2007 |
17 Jul 2007Listing of Importers of Medical Devices |
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13 Apr 2007 |
13 Apr 2007Conformity Assessment Body Recognized under the MDACS |
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30 Mar 2007 |
30 Mar 2007Proposed Guidance Notes for the Listing of Importers of Medical Devices |
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23 Mar 2007 |
23 Mar 2007Listing of Local Manufacturers of Medical Devices |
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28 Dec 2006 |
28 Dec 2006Proposed Requirements for the Listing of Local Manufacturers |
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13 Oct 2006 |
13 Oct 2006Conformity Assessment Body Recognition Scheme of the Medical Device Administrative Control System |
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16 Jun 2006 |
16 Jun 2006Proposed Documents related to Conformity Assessment under the Medical Device Administrative Control System |
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14 Nov 2005 |
14 Nov 2005Listing of Class III and Class II Medical Devices |
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01 Sep 2005 |
01 Sep 2005New Guidance Notes GN-01, GN-03 and Code of Practice COP-01 |
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16 Aug 2005 |
16 Aug 2005Proposed Guidance Notes for the Listing of Class II and Class III Medical Devices under the Medical Device Administrative Control System |
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09 May 2005 |
09 May 2005The first medical device listed under the MDACS |
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26 Nov 2004 |
26 Nov 2004Medical Device Administrative Control System |
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