Singapore Medical Device Registration Process

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HSA | Medical device registration

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

Registration and licensing requirements Tool Find out the requirements for your device's registration route and whether you need to apply for a licence. Medical device grouping tool Tool Check if you can group your medical devices for registration. Grouping …

HSA | Guidance documents for medical devices

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

Medical devices Guidance documents for medical devices Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory …

HSA | Medical devices

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

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. If your medical …

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). Determine the classification... Step 2. Registration …

Medical Device Registration and Approval in …

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

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-based company, with local staff, …

Medical Device Registration Process With HSA In …

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

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 in …

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

Medical Device Registration in Singapore: Product Owner Information in MEDICS (Jan 2022) This is with regards to the Product Owner (PO) section in the submission of a new MEDICS …

A Complete Guide to Licensing Medical Devices in …

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

A Complete Guide to Licensing Medical Devices in Singapore Speak to an advisor: +65 6929 8273 SG Incorporation Compliance Accounting Insurance Pricing Resources X Log …

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