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Singapore - Requirements for Import of Medical Devices for Clinical Trial

A

acro14

#1
Hello everyone,

does anybody know which are the requirements for the import of medical devices to Singapore intended to be used for clinical studies? Do they need to be registered or are there any exemptions regarding these devices?
So can we label a device accordingly and send it to Singapore?

Regards

John
 
Elsmar Forum Sponsor

sreenu927

Quite Involved in Discussions
#3
Hi acro14,

From a general point of view, medical devices meant for clinical studies do not require registration; you must label them properly to indicate that they are for clinical studies.

When you mentioned, "import", I believe this is not manufactured in Singapore. FYI - clinical trials in Singapore are not mandatory for registration in Singapore. If the product has already undergone clinical studies, HSA (Singapore Regulatory Authority) will accept the foreign clinical data.

Other than clinical trials, in order to import an unregistered product into Singapore, HSA allows Special Authorisation Routes (SAR) approval.

From GN-23-D1.1 Guidance on Labelling of Medical Devices (HSA Guidance document):
" If the device is intended for clinical investigation or, for in vitro diagnostic
medical devices, performance evaluation only, an indication of that
situation."

Regards,
Sreenu
 
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