Singapore Medical Device License

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HSA | Medical device registration and licensing …

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

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 …

HSA | Medical device registration

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

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 | 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 …

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 …

HSA | Apply for a medical device dealer's licence

https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

Package and label a medical device before it is supplied. Licensed manufacturers do not require a Wholesaler's licence to supply medical devices which are manufactured under …

HSA | Registration overview of medical devices

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

Class A medical devices are exempted from product registration. However, you will need to complete the Class A Exemption List in MEDICS during your dealer's licence application. …

HSA | Guidance documents for medical devices

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

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

A Complete Guide to Licensing Medical Devices in …

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

What are the regulations and classifications for medical services and medical devices in Singapore? The medical services industry in Singapore is regulated by The Health …

MOH | Licensing and Regulation - Ministry …

https://www.moh.gov.sg/licensing-and-regulation

Licensing and Regulation Licensing and Regulation Clarification MOH and SMC have noted that there were factual inaccuracies cited by DoctorXDentist (“DxD”) …

Medical Device Registration and Approval …

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

Device classification in Singapore is based on a four-tier system (Class A, B, C, and D), with Class A assigned to the lowest-risk products and Class D assigned to the highest …

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