How To Register A Medical Device In Singapore

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HSA | Medical device registration

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

Registration overview Understand the evaluation routes, fees and turn-around-times applicable when you register your medical device. Is it a medical device Tool Check if your device is considered a medical device in Singapore. Risk classification rules and factors …

HSA | Medical device registration and licensing requirements

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

Before you continue: You are encouraged to check if your product is considered a medical device in Singapore.; You will need to determine your medical device’s risk classification.; …

HSA | Registration overview of medical devices

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

The following medical devices cannot take the expedited Class C (ECR) route. These devices can only be registered via the full or abridged routes. Hip, knee and shoulder joint …

HSA | Registration guides

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

Registration guides. Once you have determined the evaluation route and risk class of your medical device, use the relevant guide to find out the documents, fees and processing …

HSA | Regulatory overview of medical devices

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

All medical devices will require registration with us before they can be supplied in Singapore, except for Class A low risk medical devices, which are exempted from product …

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 …

Medical Device Registration Process With HSA In Singapore

https://credevo.com/articles/2023/01/25/medical-device-registration-process-with-hsa-in-singapore/

Jan 25, 2023 · To register a medical device in Singapore, you would need to follow these steps: Determine the classification of your medical device according to the Health …

Singapore Medical Device Registration - Asia Actual LLC

https://asiaactual.com/singapore/medical-device-registration/

Jul 1, 2022 · Medical device registration in Singapore is overseen by the Health Sciences Authority (HSA). Medical device applications are submitted by a local entity that also acts …

Medical device registration and approval in Singapore

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

2 days ago · Foreign medical device manufacturers must appoint a Registrant to submit their device application and represent them to the HSA. The Registrant must be a Singapore …

Singapore: Medical Device Registration in Singapore

https://cmsmedtech.com/medical-device-registration-in-singapore/

Jan 1, 2022 · 1.The Health Sciences Authority (HSA) has concluded the stakeholders’ consultation on the Medical Devices Product Classification Guide on 15 April 2021. 2. …

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