Singapore Regulatory Framework Medical Device registration

Singaporean Medical devices regulation basics

Here below are reported some of the most relevant guidance for Medical Device Registration in Singaporean market:

Major Regulations

Regulation	Year
Health Products (Medical Devices) Regulations	2010
Health Products Act	2007

General Guidance Documents

Document	Year
Guidance on Change Notification for Registered Medical Devices	2018

Specific Guidance Documents

Document	Year
Guidance on Licensing for Manufacturers, Importers and Wholesalers of Medical Devices	2018
Guidance on Grouping of Medical Devices for Product Registration	2017
Guidance on Labelling for Medical Devices	2018
Guidance on Medical Device Product Registration	2019
Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN CSDT	2018
Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT	2018
Guidance on the Change of Registrant	2017
Guidance on the Risk Classification of General Medical Devices	2018

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