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Regulatory Updates

industry_briefing

Industry Briefing (Feb 2014)

[Updated on 1 April 2014]

Medical Device Branch (MDB) conducted 5 industry briefing sessions on 24, 25 and 26 February 2014 on the updates to the Change Notification for registered devices as part of the on-going enhancements to the medical device regulatory framework.

Revised guidance and presentation materials can be downloaded from the links below:

Download.IconPdfGN-21-R3 Guidance on Change Notification for Registered Medical Devices
File Size: (398 Kb)

Download.IconDocGN-21 Annex 1 Change Notification Checklist
File Size: (168 Kb)

Download.IconDocGN-21 Annex 2 Summary Table of Change Notification
File Size: (63 Kb)

Download.IconDocGN-21 Annex 3 Medical Device Safety and Performance Declaration Template
File Size: (57 Kb)

Download.IconPdfGN-24-R1 Guidance on the Change of Registrant
File Size: (230 Kb)

Download.IconDocGN-24 Annex 1 Change of Registrant Application Form
File Size: (484 Kb)

Download.IconDocGN-24 Annex 2 Relinquishing Company Declaration Form
File Size: (476 Kb)

Download.IconPdfIndustry Briefing Slides – Overview of Regulatory Updates
File Size: (319 Kb)

Download.IconPdfIndustry Briefing Slides – Enhancements to the Change Notification for Registered Medical Devices
File Size: (444 Kb)

Download.IconPdfIndustry Briefing Slides – Updates on MEDICS – Change Notification Platform
File Size: (1063 Kb)

Download.IconPdfGN-21-R3 Guidance on Change Notification for Registered Medical Devices
File Size: (386 Kb)

[Updated on 01 August 2013] HSA & Singapore Medical Association (SMA) meeting

Download.IconPdfSharing of HSA's MD regulations enhancements to Singapore Medical Association (SMA)
File Size: (549 Kb)

Consultation on Medical Devices Risk Classification Guidances

[Updated on 12 April 2013] The Medical Device Branch (MDB) would like to invite our stakeholders to provide feedback on our guidance documents on the risk classification of medical devices:

1) GN-13 Guidance on the Risk Classification of General Medical Devices

2) GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices

Download.IconPdfFor Consultation GN-13 Guidance on the Risk Classification of General Medical Devices
File Size: (750 Kb)

Download.IconXlsGN-13 Risk Classification of General Medical Devices Feedback Template
File Size: (32 Kb)

Download.IconPdfFor Consultation GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices
File Size: (745 Kb)

Download.IconXlsGN-14 Risk Classification of IVD Medical Devices Feedback Template
File Size: (33 Kb)

Please provide your feedback, proposals and reasons using the Excel forms. This information will facilitate in our collation of your suggestions and review.

Please submit your comments in the prescribed format via email to hsa_md_info@hsa.gov.sg before 12 May 2013. Please include the subject header “Risk classification feedback” for the email.

Your input is highly valued and we thank you in advance for your constructive feedback.

Industry Briefing (Nov 2012)

[Updated on 20 Dec 2012] Update to Class C and D enhancement & QMS CAD

Medical Device Branch (MDB) conducted 6 industry briefing sessions on 26, 27 and 29 November to provide an update on the various recent framework enhancements of the Medical Device Regulations, following the announcement on 20 April 2012.

Revised guidances and presentation materials can be downloaded from the links below:

Download.IconPdfGN-15-R5 Guidance on Medical Device Product Registration (Updated on Dec 2012)
File Size: (398 Kb)

Download.IconDocGN-15 Annex 1 Letter of Authorisation Template
File Size: (24 Kb)

Download.IconDocGN 15 Annex 3 Marketing History Declaration Template (Class B Registration)
File Size: (30 Kb)

Download.IconDocGN 15 Annex 4 Safety Declaration Template
File Size: (30 Kb)

Download.IconDocGN 15 Annex 7 Marketing History Declaration Template (Class C Registration)
File Size: (29 Kb)

Download.IconPdfGN-31 Quality Management System (QMS) Requirements for Licensing of Importers and Wholesalers of Class A Medical Devices (Updated Dec 2012)
File Size: (309 Kb)

Download.IconDocFORM 31A - Class A Dealer Assessment Form (Dec 2012)
File Size: (171 Kb)

Download.IconDocFORM 31B - Declaration of Non-Dealing of Class A Exempt Devices Template
File Size: (64 Kb)

Download.IconPdfIndustry Briefing Slides – Overview
File Size: (1424 Kb)

Download.IconPdfIndustry Briefing Slides– Enhancement to Change Notification for A and B Medical Devices
File Size: (2372 Kb)

Download.IconPdfIndustry Briefing Slides– Enhancement to Class C and D Medical Device Registration
File Size: (971 Kb)

Download.IconPdfIndustry Briefing Slides– Revised Regulatory Requirements for Licensing of Class A Medical Devices Dealers
File Size: (5866 Kb)

Download.IconPdfFAQ – Enhancement to Class C and D Medical Device Registration
File Size: (116 Kb)

Download.IconPdfFAQ - QMS Requirements for Class A Medical Device Dealers
File Size: (104 Kb)

[Updated on 30 August 2012] HSA & SDA members Dialogue session

Download.IconPdfHSA Update on Enhancement of MD Framework to SDA Members
File Size: (3738 Kb)

Download.IconPdfMedical Device Regulatory Framework _SDA Dialogue Session
File Size: (3310 Kb)

[Updated on 16 August 2012] Guidance on Product Registration of Class B Medical Devices

Download.IconPdfClass B Guidance on Product Registration
File Size: (130 Kb)

Download.IconPdfFrequently Asked Questions - Class B
File Size: (35 Kb)

Download.IconDocAnnex C-Marketing History Declaration Template.doc
File Size: (60 Kb)

Download.IconDocAnnex D-Safety Declaration Template.doc
File Size: (69 Kb)

Consultation on AMDD

[Updated on 2 August 2012] As part of efforts to enhance economic integration among ASEAN member states, ASEAN has been working on developing a standardised framework for regulating medical devices that is targeted for implementation by December 2014. This draft set of broad principles is called the ASEAN Medical Devices Directive (AMDD), and it is now ready for industry consultation. This published AMDD is not the final version, and there may be changes depending on feedback received from you and other interested parties.

We would like to invite you to provide your feedback on AMDD using this form and send it to HSA_MD_Query@hsa.gov.sg by 31 August 2012. We regret to inform you that we are unable to include any comments received after the deadline for consideration due to time constraints.

Download.IconPdfAMDD - Draft for consultation - 02 Aug 2012.pdf
File Size: (1169 Kb)

Download.IconDefTemplate for Comments to AMDD.DOC
File Size: (40 Kb)

Industry Briefing (Aug 2012)

[Updated on 4 Sep 2012] Medical Device Industry Briefing (Aug 2012)

MDB conducted four industry briefing sessions on 17 and 24 August to provide an update on the various recent framework enhancements of the Medical Devices Regulations, following the announcement on 20th April 2012. The focus of the sessions was on the Class A and Class B regulatory enhancements and the resulting operational enhancements made to MEDICS (Medical Device Information & Communication System).

The presentation material are attached below.

Download.IconPdfIndustry Briefing - Overview
File Size: (2946 Kb)

Download.IconPdfIndustry Briefing - Class B enhancements
File Size: (3430 Kb)

Download.IconPdfIndustry Briefing - Class A enhancements
File Size: (3078 Kb)

Import and Supply Controls

With effect from 1 November 2007:

Mandatory duties and obligations that all dealers of medical devices must fulfill, are:

  1. Duty to maintain records of import and supply
  2. Duty to maintain records of complaints
  3. Reporting of defects and adverse effects to HSA
  4. Notification to HSA concerning field safety correction actions, e.g. recall
  5. Prohibition against false or misleading advertisement.

With effect from 10th August 2010:

1) Only licenced dealers can manufacture, import or wholesale medical devices (regardless of the risk classification of the medical devices). Click here for more information regarding the licences

2) The import and supply of medical devices that are licensable under the Radiation Protection Act (Cap. 262) by the Centre for Radiation Protection and Nuclear Science (CRPNS) of the National Environment Agency (NEA), shall be exempted from the importer's and wholesaler's licensing requirements under the Health Products Act. However, product registration for such medical devices are mandatory with effect from 1 August 2011. To import and supply, the devices must meet one of the criteria below:

With effect from 1 January 2012:

All medical devices regardless of its risk classification (unless exempted from product registration), to imported and supplied must meet one of the criteria below:

Please refer to our Frequently Asked Questions (FAQ) for more information.

For an understanding of the product registration and licensing of dealers process and requirements, you can download the following Quick Guide.

Please refer to our Target Processing Timelines for more information on product registration registration timelines.

Download.IconPdfHSA Press Release
File Size: (185 Kb)

Industry Briefing on the Implementation of Health Products (Medical Devices) Regulation Presentation Slides

Presentation slides for briefings conducted before Apr 2010 have been archived and are no longer available for download. To download the presentation slides for briefings conducted after Apr 2010, please click on the links below:

Download.IconPdfJul 2010: Briefing on Secondary Assembly
File Size: (137 Kb)

Download.IconPdfApril 2010: Medical Device Industry Briefing
File Size: (247 Kb)

Download.IconPdfOct 2010: Class A Medical Device Registration Submissions
File Size: (3949 Kb)

Download.IconPdfMay 2011: Medical Device Industry Briefing
File Size: (672 Kb)

With reference to email notice (Ref: HSA 600:07/04(032)) sent on 17 Jun 2011, for the purpose of device listing retention, Letter of Authorisation (LOA) from product owner shall be required for all device listings. Slides 52 and 53 of the May 2011 briefing slides have been updated to reflect this. Please use LOA template updated on 17 Jun 2011.

Download.IconPdfAugust 2011: Briefing for Optometrists
File Size: (476 Kb)

Download.IconPdfNovember 2011: Focus Group Session on Grouping of Dental Devices
File Size: (2368 Kb)

[Updated on 20 April 2012] Opening Address by Dr Amy Khor, Minister of State

Download.IconPdfOpening Address by Dr Amy Khor, Minister of State
File Size: (225 Kb)

[Updated on 20 April 2012] HSA Press Release

Download.IconPdfHSA Press Release
File Size: (185 Kb)

[Updated on 20 April 2012] Enhancements to the Medical Device Regulatory Framework

Download.IconPdfHSA Letter to MD Industry
File Size: (99 Kb)