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What's New

  Briefing sessions on Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Device (Updated on 13 Nov 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. (Updated on 9 Oct 2018)
 
  Notice to local manufacturers in applying for medical device registration in Mainland China (Updated on 31 May 2018)
 
  Revised GN-07 (Guidance Notes for Listing of Importers of Medical Devices) and associated document are issued (Updated on 31 May 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) (Updated on 18 Apr 2018)
 
  An updated " What is Medical Device?" pamphlet has just been posted. (Updated on 26 Mar 2018)
 
  Lists of classified examples of In Vitro Diagnostic Medical Devices (IVDMDs) under the MDACS have just been posted. (Updated on 28 Feb 2018)
 
  An updated "Know more about Home-use Blood Glucose Meter" pamphlet has just been posted. (Updated on 13 Feb 2018)
 
  An updated "Tips on Using Contact Lens Solution" pamphlet has just been posted. (Updated on 16 Oct 2017)
 
  Updated information brochures regarding "Oxygen Concentrator" and "Obstructive Sleep Apnea and CPAP Respirator" have just been posted. (Updated on 21 Apr 2016)
 
  Removal Notice Medical Device Control Office of Department of Health
 
  Consultancy Study on the Control of Use of Selected Medical Devices in Hong Kong. (Updated on 29 Oct 2015)
 
  A new information pamphlet "Tips on Using Home-use In Vitro Diagnostic Medical Devices" has just been posted. (Updated on 8 Jul 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. (Updated on 9 Jun 2015)
 
  Listing of Distributors of Medical Devices (Updated on 30 Apr 2015)
 
  An updated information brochure regarding "What to consider when you select, purchase and use a medical device" has just been posted. (Updated on 9 Mar 2015)
 
  Two briefing sessions on the draft Guidance Notes for Listing of Distributors were successfully conducted on 25 and 26 Nov.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. (5 Dec 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. (Updated on 15 May 2014)
 
  An updated information brochure regarding the classification, selection and caring of contact lenses has just been posted. (Updated on 16 Apr 2014)
 
  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. ( 11 Jul 2011 )
 
  FAQs related to Medical Devices containing DEHP ( 15 Jun 2011 )
 
  Additional Health Products Co-Packaged with Recall Alcohol Pre Pads (Posted on 7 Feb 2011)
 
  Shandex Sales Group Urgently Recalls Alcohol Swabs (Posted on 14 Jan 2011)
 
  Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination (Posted on 7 Jan 2011)
 
  Discussion Forums on Proposed Framework for Statutory Regulation of Medical Devices (Posted on 25 Aug 2010)
 
  New Guidance Notes GN-00 and Technical Reference TR-003 (Posted on 15 Jan 2010)
 
  Listing Class D In Vitro Diagnostic (IVD) Medical Devices (Posted on 1 Dec 2009)
 
  Proposed Document - Guidance Notes for Applicants of the Certificate for Clinical Trial on Medical Device (Posted on 1 Nov 2009)
 
  Registration for The 14th AHWP Meeting and Pre-meeting Workshop (Posted on 6 Oct 2009)
 
  Reusable Endoscopic / Laparoscopic instruments and accessories (Posted on 24 Aug 2009)
 
  Presentation for Workshop on Application for Listing Medical Devices (Posted on 15 Jul 2009)
 
  Medical Device Administrative Control System uses Asian Medical Device Nomenclature System (AMDNS) (Posted on 19 Jun 2009)
 
  Proposed documents related to listing In Vitro Diagnostic (IVD) Medical Devices (Posted on 23 Mar 2009)
 
  Hot / Cold Gel Pack (Posted on 16 Oct 2008)
 
  Supplementary Notes for Submitting Applications for Listing Medical Devices under the Medical Device Administrative Control System (Posted on 11 Jun 2008)

  Regulatory Impact Assessment on the Proposed Regulation of Medical Devices in Hong Kong (Posted on 30 Aug 2007)

  Listing of Importers of Medical Devices (Posted on 17 Jul 2007)

  Conformity Assessment Body Recognized under the MDACS (Posted on 13 Apr 2007)

  Proposed Guidance Notes for the Listing of Importers of Medical Devices (Posted on 30 Mar 2007)

  Listing of Local Manufacturers of Medical Devices (Posted on 23 Mar 2007)

  Educational Materials Regarding Breast Augmentation (Posted on 29 Jan 2007)

  Proposed Requirements for the Listing of Local Manufacturers (Posted on 28 Dec 2006)

  Conformity Assessment Body Recognition Scheme of the Medical Device Administrative Control System (13 Oct 2006)

  Consultation on Proposed Import Control on Polyacrylamide Gel (PAAG) (27 Jul 2006)

  Opening Hours under Five-day Week Schedule (20 Jun 2006)

  Proposed Documents related to Conformity Assessment under the Medical Device Administrative Control System (16 Jun 2006)

  Bausch & Lomb withdraws ReNu with MoistureLoc contact lens solution from the USA (24 Apr 2006)

  Risks of Using Polyacrylamide Gel (PAAG) for Breast Augmentation (21 Apr 2006)

  Letter to doctor about the use of Polyacrylamide Gel (PAAG) for breast augmentation (12 Apr 2006)

  Tips for Using Contact Lens Solution (4 Apr 2006)

  Pamphlet: What is "Medical Device"? (1 Mar 2006)

  Pamphlet: What is Contact Lens? (18 Feb 2006)

  Listing of Class III and Class II Medical Devices (14 Nov 2005)

  LifeScan Voluntarily Removes and Replaces Certain Blood Glucose Monitoring Products (5 Sep 2005)

  New Guidance Notes GN-01, GN-03 and Code of Practice COP-01 (1 Sep 2005)

  Proposed Guidance Notes for the Listing of Class II and Class III Medical Devices under the Medical Device Administrative Control System (16 Aug 2005)

  The United States Food and Drug Administration Announces Recall of Baxter Healthcare's Colleague Volumetric Infusion Pumps (22 Jul 2005)

  MHRA Alert: Styrene polymer based surgical and examination gloves may disintegrate when in contact with certain solvent (12 Jul 2005)

  The first medical device listed under the MDACS (9 May 2005)

Medical Device Administrative Control System (launched on 26 Nov 2004)
 
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Last Revision Date : 13 November 2018