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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-R4.1 Guidance on Licensing for Manufacturers, Importers and Wholesalers of Medical Devices (Updated on 21 Aug 2018)
File Size: (808 Kb)

Download.IconDocGN-02 Annex 1 Declaration for Exemption from GDPMDS
File Size: (48 Kb)

Download.IconDocGN-02 Annex 3 Summary Table of Amendments
File Size: (30 Kb)

Download.IconDocGN-02 Annex 5 Declaration of Conformity to a QMS
File Size: (48 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-R2.2 Guidance on Medical Device Recall
File Size: (340 Kb)

Download.IconPdfGN-05-R2.1 Guidance on Reporting of Adverse Events for Medical Devices
File Size: (358 Kb)

Download.IconPdfGN-06-R2.2 Guidance on Distribution Records for Medical Devices
File Size: (317 Kb)

Download.IconPdfGN-07-R2.2 Guidance on Complaint Handling of Medical Devices
File Size: (319 Kb)

Download.IconPdfGN-08-R2 Guidance on Medical Devices Advertisements and Sales Promotion of Medical Devices (Updated on 4 June 2018)
File Size: (216 Kb)

Download.IconPdfGN-09-R3.3 Guidance on the Component Elements of a Dear Healthcare Professional Letter
File Size: (560 Kb)

Download.IconDocGN-09 R3.3 Annex 1 Dear Healthcare Professional Template
File Size: (48 Kb)

Download.IconPdfGN-10-R3.3 Guidance on Medical Device Field Safety Corrective Action (Updated on 21 August 2018)
File Size: (667 Kb)

Download.IconDocGN-10 Annex 1 Declaration on Completion of Correction Template
File Size: (98 Kb)

Download.IconPdfGN-11-R1.3 Guidance on the Declaration of Conformity (Updated on 1 June 2018)
File Size: (391 Kb)

Download.IconDocGN-11 Declaration of Conformity Template
File Size: (29 Kb)

Download.IconPdfGN-12-1-R2.1 Guidance on Grouping of Medical Devices for Product Registration - General Grouping Criteria (Updated on Nov 2017)
File Size: (617 Kb)

Download.IconPdfGN-12-2-R1.1 Guidance on Grouping of Medical Devices for Product Registration - Device Specific Grouping Criteria (Updated on Nov 2017)
File Size: (663 Kb)

Download.IconPdfGN-13-R2 Guidance on the Risk Classification of General Medical Devices (Updated 1 June 2018)
File Size: (543 Kb)

Download.IconPdfGN-14-R2 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (Updated on 1 June 2018)
File Size: (446 Kb)

Download.IconPdfGN-15-R7.1 Guidance on Medical Device Product Registration (Updated on 21 August 2018)
File Size: (1024 Kb)

Download.IconDocGN-15 Annex 1 Letter of Authorisation Template
File Size: (30 Kb)

Download.IconDocGN-15 Annex 2 Marketing History Declaration Template
File Size: (31 Kb)

Download.IconDocGN-15 Annex 3 Safety Declaration Template
File Size: (32 Kb)

Download.IconPdfGN-16-R2 Guidance on Essential Principles for Safety and Performance of Medical Devices (Updated on 1 June 2018)
File Size: (404 Kb)

Download.IconDocAnnex 2 GN-16 R2 Essential Priniciples Checklist Template (June 2018 version)
File Size: (163 Kb)

Download.IconDocAnnex 3 GN-16 R2 Essential Principles Checklist Template (Dec 2017 version)
File Size: (119 kb)

Download.IconPdfGN-17-R1 Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT
File Size: (553 Kb)

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

Download.IconPdfGN-18-R1 Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic (IVD) Medical Devices using the ASEAN CSDT
File Size: (601 Kb)

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

Download.IconPdfGN-20-R1 Guidance on Clinical Evaluation
File Size: (542 Kb)

Download.IconPdfGN-21-R4.4 Guidance on Change Notification for Registered Medical Devices
File Size: (1160 Kb)

Download.IconDocAnnex 2 to GN-21 R4.3 Guidance on Change Notification for Registered Medical Devices (Updated on 1 June 2018)
File Size: (42 Kb)

Download.IconDocAnnex 3 to GN-21 R4.4 Guidance on Change Notification for Registered Medical Devices (Updated on 21 August 2018)
File Size: (35 Kb)

Download.IconPdfGN-22-R7 Guidance for Dealers on Class A Medical Devices (Updated on 1 June 2018)
File Size: (418 Kb)

Download.IconPdfGN-23-R1 Guidance on Labelling for Medical Devices (Updated on 1 June 2018)
File Size: (349 Kb)

Download.IconPdfGN-24-R1.3 Guidance on the Change of Registrant
File Size: (603 Kb)

Download.IconDocGN-24 Annex 1 Change of Registrant Application Form
File Size: (485 Kb)

Download.IconDocGN-24 Annex 2 Relinquishing Company Declaration Form
File Size: (477 Kb)

Download.IconPdfGN-25-R1 Guidance on the Cancellation of Medical Device Listing
File Size: (328 Kb)

Download.IconPdfGN-26-R2.2 Guidance on Authorisation route for import and supply on request by qualified practitioner (Updated on September 2018)
File Size: (617 Kb)

Download.IconDocGN-26-R2.2 For patient of Qualified Practitioner Application Form (MDSA-NP) (Updated on September 2018)
File Size: (636 Kb)

Download.IconPdfGN-27-R2.2 Guidance on Authorisation route for import and supply on request by PHMC licenced facility (Updated on September 2018)
File Size: (629 Kb)

Download.IconDocGN-27-R2.2 For patients of PHMC Licensed Clinical Laboratory, Medical Clinic or Private Hospital Application Form (MDSA-HL) (Updated on September 2018)
File Size: (631 Kb)

Download.IconPdfGN-28-R2.2 Guidance on Authorisation Route for Import for Re-Export (Updated on September 2018)
File Size: (428 Kb)

Download.IconDocGN-28-R2.2 Import for Re-Export Application Form (MDSA-IR) (Updated on September 2018)
File Size: (639 Kb)

Download.IconPdfGN-29-R2.2 Guidance on Authorisation Route for Import and Supply for Non-Clinical Purpose (Updated on September 2018)
File Size: (472 Kb)

Download.IconDocGN-29-R2.2 Import to Supply for Non-Clinical Purpose Application Form (MDSA-NC) (Updated on September 2018)
File Size: (623 Kb)

Download.IconPdfGN-30-R3.1 Guidance on Authorisation Route for Import on Consignment Basis (Updated on September 2018)
File Size: (466 Kb)

Download.IconDocGN-30CR Import Medical Devices on Consignment Basis (Registered) Application Form (MDSA-CR) (Updated on September 2018)
File Size: (620 Kb)

Download.IconDocAnnex 1 Distribution Records (Updated on September 2018)

File Size: (34 Kb)

Download.IconDocAnnex 2 List of Devices (Updated on September 2018)
File Size: (51 Kb)

Download.IconDocAnnex 4 Product Owner Authorisation Template (Updated on September 2018)

File Size: (25 Kb)

Download.IconPdfGN32 R3.2 Guidance Notes for Importation of Unregistered Medical Devices for Exhibition in Singapore (Updated on Sept 2018)
File Size: (629 Kb)

Download.IconPdfFORM 32-A: Application for Importer’s Licence, Importation of Unregistered Medical Devices for Exhibition (Updated on Sept 2018)
File Size: (380 Kb)

Download.IconPdfGN-33 R1.2 Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices (Updated on Jul 2018)
File Size: (565 Kb)

Download.IconPdfGN-34 R1.2 Guidance Document for IVD Analysers (Updated on 19 September 2018)
File Size: (793 Kb)

Download.IconXlsAnnex 2 to GN-34
File Size: (19 Kb)

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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

 

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)