GN-08 Guidance on Medical Devices Advertisements and Sales Promotion of Medical Devices

GN-17 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT

GN-18 Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic (IVD) Medical Devices using the ASEAN CSDT

Annex 2 for GN18 List of Configurations of Medical Devices to be Registered _IVD CLUSTERS

Annex 2 for GN17 and GN18 List of Configurations of Medical Devices to be Registered

GN-20 Guidance on Clinical Evaluation

GN-23 Guidance on Labelling for Medical Devices

GN-24 Guidance on the Change of Registrant

GN-25 Guidance on the Cancellation of Medical Device Listing

GN-01-R3 Guidance on the Application of Good Distribution Practice for Medical Devices in Singapore (Updated on Oct 2011)

GN-02-R2 Guidance on Licensing for Manufacturers, Importers and Wholesalers of Medical Devices (Updated on Nov 2011)

GN-02_Declaration for Exemption from GDPMDS Template

GN-02: Summary Table of Amendments or Notifications at Point of Licence Renewal

GN-02: List of Class A Exempted Medical Devices Template

GN-03-R3 Guidance on Preparation of a Site Master File for Licensing

SMF Example for GN-03 Guidance on Preparation of a Site Master File for Licensing

GN-04-R1 Guidance on Medical Device Recall

GN-05-R1 Guidance on Reporting of Adverse Events for Medical Devices

GN-06-R1 Guidance on Distribution Records for Medical Devices

GN-07-R1 Guidance on Complaint Handling of Medical Devices

GN-09-R1 Guidance on the Component Elements of a Dear Healthcare Professional Letter

GN-10-R1 Guidance on Medical Device Field Safety Corrective Action

GN-11-R1 Guidance on the Declaration of Conformity (Updated on Nov 2011)

GN-11 Declaration of Conformity Template

GN-12-R1 Guidance on Grouping of Medical Devices for Product Registration

GN-13-R1 Guidance on the Risk Classification of General Medical Devices

GN-14-R1 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices

GN-15-R4.1 Guidance on Medical Device Product Registration (Updated on Nov 2011)

GN-15 Letter of Authorisation Template

GN-16-R1 Guidance on Essential Principles for Safety and Performance of Medical Devices

GN-16 Essential Principles Checklist Template

GN-21-R2 Guidance on Change Notification for Registered Medical Devices

GN-21 Change Notification Checklist

GN-21 Change Notification Regulatory Status Summary

GN-22-R6 Guidance for Dealers on Class A Medical Devices Exempted from Product Registration (Updated on May 2012)

GN-26-R1: Guidance on the Requirements for Exemption from Product Registration for the Import of an Unregistered Medical Device for Supply on Named-Patient Basis

GN-27-R1: Guidance on the Requirements for Exemption from Product Registration for the Import of Unregistered Medical Devices for Supply to a Clinical Laboratory, Medical Clinic or Private Hospital licensed under the PHMC Act

GN-28-R1: Guidance on the Requirements for Exemption from Product Registration to Import Unregistered Medical Devices solely for Re-export or for the Export of Unregistered Medical Devices

GN-29-R1: Guidance on the Requirements for Exemption from Product Registration to Supply Imported or Manufactured Unregistered Medical Devices for Non-Clinical Purpose

GN-30-R1: Guidance on the Requirements for Approval to Import Medical Devices on Consignment Basis

TS-01-R2 Good Distribution Practice for Medical Devices in Singapore - Requirements