Medical Device Regulations In Singapore

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HSA | Regulatory overview of medical devices

https://www.hsa.gov.sg/medical-devices/regulatory-overview

We require companies to obtain a dealer's licence before manufacturing, importing or supplying medical devices. All medical devices will require registration with us before they can be supplied in Singapore, except for Class A low risk medical devices, which …

HSA | Medical devices

https://www.hsa.gov.sg/medical-devices

Medical devices are health products which have a physical or mechanical effect when used on human bodies. These devices are used to: Diagnose, alleviate or treat a medical …

Health Products (Medical Devices) Regulations 2010

https://sso.agc.gov.sg/SL/HPA2007-S436-2010

Health Products Act. (Chapter 122D) Health Products (Medical Devices) Regulations 2010. In exercise of the powers conferred by sections 45, 71 and 72 of the Health Products Act, …

QUICK GUIDE TO MEDICAL DEVICE PRODUCT …

https://www.hsa.gov.sg/docs/default-source/hprg-mdb/quick-guide-to-md-registration-and-licensing_may-2021.pdf

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

A Complete Guide to Licensing Medical Devices in …

https://sleek.com/sg/resources/medical-devices-licensing/

The medical services industry in Singapore is regulated by The Health Sciences Authority (HSA) that administers the national regulatory framework for pharmaceuticals, …

Singapore - Healthcare - International Trade Administration

https://www.trade.gov/country-commercial-guides/singapore-healthcare

Medical devices are regulated under the Health Products Act and Health Products (Medical Devices) regulations. Singapore’s Health Sciences Authority (HSA) …

Medical Device Registration and Approval …

https://www.emergobyul.com/services/medical-device-registration-and-approval-singapore

These regulations dictate how medical devices are classified in Singapore and the registration routes for each class. Device classification in Singapore is based on a …

Singapore Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/singapore/

A medical device means any instrument, apparatus, implement, machine, appliance, implant, in vitro ...

Medical Device Regulation Singapore - CMS MedTech

https://cmsmedtech.com/medical-device-regulation-singapore/

Medical Device Regulation Singapore. Medical Device registration is compulsory in Singapore. This means you will need to register your medical device …

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