October 15, 2018

Just as the previous months, September and early October 2018 saw several updated guidance documents and official forms published in HSA website. This is to conform with the other documents with major revisions earlier this year. HSA stakeholders should take note that these updated files don’t have any regulatory changes with respect to their versions. The following is the list of the mentioned guidance documents with the latest document title:

Guidance	Document title
Licensing of Manufacturers, Importers and Wholesalers of MD	GN-02-R4.1 Guidance on Licensing of Manufacturers, Importers and Wholesalers of MD (18Aug-pub)
Component Elements of a Dear Healthcare Professional Letter	GN-09-R3.4 Guidance on the Component Elements of a Dear Healthcare Professional Letter (18Oct-pub)
Medical Device Field Safety Corrective Action	GN-10-R3.4 Guidance on Medical Device Field Safety Corrective Action (18Oct-pub)
Risk Classification of General Medical Devices	GN-13-R2.1 Guidance on the Risk Classification of General Medical Devices (18Sep-pub)
Guidance on Medical Device Product Registration	GN-15-R7.1 Guidance on Medical Device Product Registration (18Aug-pub)
Guidance on Authorization Route for Import and Supply on Request by Qualified Practitioner	GN-26-R2.2 Guidance on Authorisation Route for Import and Supply on Request by Qualified Practitioner (18Sep-pub)
Authorization route for import and supply on request by PHMC licensed facility	GN-27-R2.2 Guidance on Authorisation route for import and supply on request by PHMC licenced facility (18Sep-pub)
Authorisation Route for Import for Re-Export	GN-28-R2.2 Guidance on Authorisation Route for Import for Re-Export (18Sep-pub)
Authorisation Route for Import and Supply for Non-Clinical Purpose	GN-29-R2.2 Guidance on Authorisation Route for Import and Supply for Non-Clinical Purpose (18Sep-pub)
Requirements for Approval to Import on Consignment Basis	GN-30-R3.1 Guidance on Requirements for Approval to Import on Consignment Basis (18Sep-pub)
Notes for Importation of Unregistered Medical Devices for Exhibition in Singapore	GN32 R3.2 Guidance Notes for Importation of Unregistered Medical Devices for Exhibition in Singapore (18Sep-pub)
Application for Importer’s Licence, Importation of Unregistered Medical Devices for Exhibition (Template attached in GN 32)	FORM 32-A: Application for Importer’s Licence, Importation of Unregistered Medical Devices for Exhibition (18Sept-pub)
Document for IVD Analysers	GN-34 R1.2 Guidance Document for IVD Analysers (18Sept-pub)

HSA aims to conform the guidance documents to their latest versions. The updated documents can be found in the Guidance section of HSA website. Industry people together with concerned stakeholders are encouraged to use the latest documents to get the latest information in Singapore Medical Device Regulations.

Reference:

Kindly follow the links of the updated Guidance Documents and Forms in the table above.