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. 

GN-15-R5 Guidance on Medical Device Product Registration (Updated on Dec 2012)

GN-15 Annex 1 Letter of Authorisation Template 

GN 15 Annex 3 Marketing History Declaration Template (Class B Registration) 

GN 15 Annex 4 Safety Declaration Template 

GN 15 Annex 7 Marketing History Declaration Template (Class C Registration) 

GN-31 Quality Management System (QMS) Requirements for Licensing of Importers and Wholesalers of Class A Medical Devices (Updated Dec 2012)

FORM 31A - Class A Dealer Assessment Form (Dec 2012)

FORM 31B - Declaration of Non-Dealing of Class A Exempt Devices Template

Industry Briefing Slides – Overview

Industry Briefing Slides– Enhancement to Change Notification for A and B Medical Devices

Industry Briefing Slides– Enhancement to Class C and D Medical Device Registration

Industry Briefing Slides– Revised Regulatory Requirements for Licensing of Class A Medical Devices Dealers

FAQ – Enhancement to Class C and D Medical Device Registration

HSA Update on Enhancement of MD Framework to SDA Members

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

HSA Update on Enhancement of MD Framework to SDA Members

Medical Device Regulatory Framework _SDA Dialogue Session

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

Class B Guidance on Product Registration

Frequently Asked Questions - Class B

Annex C-Marketing History Declaration Template

Annex D-Safety Declaration Template