Singapore Regulations For Medical Devices

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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, …

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 - AGC

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

the components or composition of the medical device; (d) the fitness for purpose (including expiry date), strength, performance, behaviour or accuracy of the …

HSA | Health products regulation

https://www.hsa.gov.sg/about-us/health-products-regulation/

Product Regulations. Medical devices; Therapeutic products; Health supplements; Traditional medicines; Chinese proprietary medicines; Cosmetic products; Tobacco regulation; CTGTP; More Regulations. …

How medical devices are regulated by HSA

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

How are medical devices regulated in Singapore? Product Registration - Medical devices must be registered with HSA to ensure they meet the regulatory requirements...

HSA | Risk classification of medical devices

https://www.hsa.gov.sg/medical-devices/registration/risk-classification-rule

If one medical device is intended to be used together with another medical device, the risk classification rules shall apply separately to each of the medical devices. This is …

Safe use of medical devices - Health Sciences Authority …

https://www.hsa.gov.sg/consumer-safety/articles/safe-use-of-medical-devices

For safety purposes, manufacturers, importers and wholesalers in Singapore must be licensed, and medical devices must be registered with HSA to ensure they meet …

Medical Device Registration and Approval in …

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 (Medical Devices) Regulations 2010. These …

HSA | Advertisements and promotions of medical devices

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

All medical advertisements must also comply with the Singapore Code of Advertising Practice (SCAP) administered by the Advertising Standards Authority of …

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