Medical device registration in Brunei

K

K.Katerina

Hi all,
Does anyone know about the medical device regulation in Brunei? Do medical devices need registration or they just require an import permit like in Qatar? Thank you in advance for your help!
 

angwm

Registered
Hi, I am looking for the same in 2023. So does Brunei require medical device registration now? I have been searching for information but there is so little (or no) information on this.. any help please?
 

divyag

Starting to get Involved
The current landscape, manufacturers intending to market medical devices in Brunei would only need to comply with Ministry of Finance and Brunei’s Royal Customs and Excise Department (RCED) in order to obtain a company registration number and customs clearance. They are still in the process of the Medical Device Directive implementation.
 

Shybutnotshy

Registered
The current landscape, manufacturers intending to market medical devices in Brunei would only need to comply with Ministry of Finance and Brunei’s Royal Customs and Excise Department (RCED) in order to obtain a company registration number and customs clearance. They are still in the process of the Medical Device Directive implementation.
Does registration require CE mark?
 
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