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This application is a service of the Singapore Government.

Health Sciences Authority

Regulatory Guidances

Guidance Documents

Download.IconPdfGN-01-R3 Guidance on the Application of Good Distribution Practice for Medical Devices in Singapore (Updated on Oct 2011)
File Size: (135 Kb)

Download.IconPdfGN-02 Guidance on Licensing for Manufacturers, Importers and Wholesalers of Medical Devices (Updated on Sep 2015 - No changes in requirements)
File Size: (268 Kb)

Download.IconDocGN-02_Declaration for Exemption from GDPMDS Template
File Size: (75 Kb)

Download.IconDocGN-02: Summary Table of Amendments
File Size: (28 Kb)

Download.IconPdfGN-03-R3 Guidance on Preparation of a Site Master File for Licensing

File Size: (71 Kb)

Download.IconPdfSMF Example for GN-03 Guidance on Preparation of a Site Master File for Licensing
File Size: (84 Kb)

Download.IconPdfGN-04-R2.1 Guidance on Medical Device Recall
File Size: (212 Kb)

Download.IconPdfGN-05-R2 Guidance on Reporting of Adverse Events for Medical Devices
File Size: (121 Kb)

Download.IconPdfGN-06-R2.1 Guidance on Distribution Records for Medical Devices
File Size: (192 Kb)

Download.IconPdfGN-07-R2.1 Guidance on Complaint Handling of Medical Devices
File Size: (192 Kb)

Download.IconPdfGN-08 Guidance on Medical Devices Advertisements and Sales Promotion of Medical Devices (Updated on December 2013)
File Size: (343 Kb)

Download.IconPdfGN-09-R3 Guidance on the Component Elements of a Dear Healthcare Professional Letter
File Size: (251 Kb)

Download.IconDocGN-09 Annex 1 Dear Healthcare Professional Template
File Size: (43 Kb)

Download.IconPdfGN-10-R3 Guidance on Medical Device Field Safety Corrective Action
File Size: (350 Kb)

Download.IconDocGN-10 Annex 1 Declaration on Completion of Correction Template
File Size: (97 Kb)

Download.IconPdfGN-11-R1.1 Guidance on the Declaration of Conformity (Updated on May 2014)
File Size: (178 Kb)

Download.IconDocGN-11 Declaration of Conformity Template
File Size: (26 Kb)

Download.IconPdfGN-12-1-R2 Guidance on Grouping of Medical Devices for Product Registration - General Grouping Criteria (Updated on June 2016)
File Size: (695 Kb)

Download.IconPdfGN-12-2-R1 Guidance on Grouping of Medical Devices for Product Registration - Device Specific Grouping Criteria (Updated on June 2016)
File Size: (714 Kb)

Download.IconPdfGN-13-R1.1 Guidance on the Risk Classification of General Medical Devices
File Size: (914 Kb)

Download.IconPdfGN-14-R1.1 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices
File Size: (204 Kb)

Download.IconPdfGN-15-R6.1 Guidance on Medical Device Product Registration (Updated on May 2014)
File Size: (411 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-16-R1.1 Guidance on Essential Principles for Safety and Performance of Medical Devices
File Size: (226 Kb)

Download.IconDocGN-16 Essential Principles Checklist Template
File Size: (119 Kb)

Download.IconPdfGN-21-R4 Guidance on Change Notification for Registered Medical Devices (Updated on Dec 2015)
File Size: (395 Kb)

Download.IconDocGN-21 R4 Annex 2 Summary Table of Change Notification (Updated on Dec 2015)
File Size: (41 Kb)

Download.IconDocGN-21 R4 Annex 3 Medical Device Safety and Performance Declaration Template (Updated on Dec 2015)
File Size: (34 Kb)

Download.IconPdfGN-22-R6.2 Guidance for Dealers on Class A Medical Devices Exempted from Product Registration (Updated on June 2016)
File Size: (264 Kb)

Download.IconPdfGN-24-R1.1 Guidance on the Change of Registrant (Updated on May 2014)
File Size: (230 Kb)

Download.IconDocGN-24 Annex 1 Change of Registrant Application Form (Updated on 1 April 2014)
File Size: (484 Kb)

Download.IconDocGN-24 Annex 2 Relinquishing Company Declaration Form (Updated on 1 April 2014)
File Size: (476 Kb)

Download.IconPdfGN-26-R2 Guidance on Authorisation route for import and supply on request by qualified practitioner (Updated on June 2016)
File Size: (360 Kb)

Download.IconDocGN-26-R2 For patient of Qualified Practitioner Application Form (MDSA-NP) (Updated on June 2016)
File Size: (636 Kb)

Download.IconPdfGN-27-R2 Guidance on Authorisation route for import and supply on request by PHMC licenced facility (Updated on June 2016)
File Size: (364 Kb)

Download.IconDocGN-27-R2 For patients of PHMC Licensed Clinical Laboratory, Medical Clinic or Private Hospital Application Form (MDSA-HL) (Updated on June 2016)
File Size: (632 Kb)

Download.IconPdfGN-28-R2 Guidance on Authorisation Route for Import for Re-Export (Updated on June 2016)
File Size: (322 Kb)

Download.IconDocGN-28-R2 Import for Re-Export Application Form (MDSA-IR) (Updated on June 2016)
File Size: (640 Kb)

Download.IconPdfGN-29-R2 Guidance on Authorisation Route for Import and Supply for Non-Clinical Purpose (Updated on June 2016)
File Size: (349 Kb)

Download.IconDocGN-29-R2 Import to Supply for Non-Clinical Purpose Application Form (MDSA-NC) (Updated on June 2016)
File Size: (623 Kb)

Download.IconPdfGN-30-R2 Guidance on Authorisation Route for Import on Consignment Basis (Updated on June 2016)
File Size: (379 Kb)

Download.IconDocGN-30CR-R2 Import Medical Devices on Consignment Basis (Registered) Application Form (MDSA-CR) (Updated on June 2016)
File Size: (622 Kb)

Download.IconDocGN-30CUR-R2 Import Medical Devices on Consignment Basis (Unregistered) Application Form (MDSA-CUR) (Updated on June 2016)
File Size: (619 Kb)

Download.IconDocAnnex 1-R2 Distribution Records (Updated on June 2016)
File Size: (33 Kb)

Download.IconDocAnnex 2-R2 List of Devices (Updated on June 2016)
File Size: (51 Kb)

Download.IconDocAnnex 3-R2 Distribution Records (for GN-30CUR) (Updated on June 2016)
File Size: (35 Kb)

Download.IconDocAnnex 4-R2  Product Owner Authorisation Template (Updated on June 2016)
File Size: (24 Kb)

Download.IconPdfGN-31 Guidance on Quality Management System Requirements for Licensing of Importers and Wholesalers of Class A Medical Devices (QMS CAD) (Updated Sep 2015 - No changes in requirements)
File Size: (309 Kb)

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

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

Download.IconPdfGN32: Guidance Notes for Importation of Unregistered Medical Devices for Exhibition in Singapore (Updated on Jan 2016)
File Size: (432 Kb)

Download.IconPdfFORM 32-A: Application for Importer’s Licence, Importation of Unregistered Medical Devices for Exhibition
File Size: (253 Kb)

Download.IconPdfFORM 32-B: Request for Letter of No Objection, Importation of Unregistered Medical Devices for Exhibition
File Size: (190 Kb)

Download.IconPdfFORM 32-C: Declaration on Status of Unregistered Medical Devices for Exhibition
File Size: (242 Kb)

Draft Guidance Documents for Consultation

Please use the Template for Comments to provide any inputs on the draft Guidance Documents.

Please submit your comments to HSA_MD_INFO@HSA.gov.sg

Download.IconPdfGN-17-D1.1 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT
File Size: (887 Kb)

Download.IconXlsAnnex 2 for GN17 and GN18 List of Configurations of Medical Devices to be Registered
File Size: (86 Kb)

Download.IconPdfGN-18-D1.1 Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic (IVD) Medical Devices using the ASEAN CSDT
File Size: (981 Kb)

Download.IconXlsAnnex 2 for GN18 List of Configurations of Medical Devices to be Registered _IVD CLUSTERS
File Size: (49 Kb)

Download.IconPdfGN-20-D1.1 Guidance on Clinical Evaluation
File Size: (1003 Kb)

Download.IconPdfGN-23-D1.1 Guidance on Labelling for Medical Devices
File Size: (694 Kb)

Download.IconPdfGN-25-D1.1 Guidance on the Cancellation of Medical Device Listing
File Size: (628 Kb)

Download.IconDocGN-25 Annex 1 Cancellation of Medical Device Listing Application Form
File Size: (475 Kb)

Technical Specification Documents

Download.IconPdfTS-01-R2.1 Good Distribution Practice for Medical Devices in Singapore - Requirements (Updated on 1 Sept 2012)
File Size: (732 Kb)