Regulatory Medical Device 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 …

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 …

How medical devices are regulated by HSA

https://www.hsa.gov.sg/consumer-safety/articles/how-medical-devices-are-regulated-by-hsa

Medical devices have a physical or mechanical effect on the body, and are used to diagnose, alleviate or treat medical conditions. They may also be used to measure or …

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, …

Medical Device Registration and Approval …

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

Singapore is a member of the Association of Southeast Asian Nations (ASEAN) and its regulatory system is based on the Health Products Act 2007 and Health Products …

Singapore Regulatory Approval Process for …

https://www.emergobyul.com/resources/singapore-regulatory-approval-process-medical-devices

The medical device approval process in Singapore explained Step 1 Medical Devices in Singapore are governed by the Health Sciences Authority (HSA). …

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 reagent or calibrator, software, material or other similar or related article …

Health Products (Medical Devices) Regulations 2010

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

“medical device” means a medical device referred to in the First Schedule to the Act; “medicinal product” has the same meaning as in section 3 of the Medicines Act (Cap. …

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