Medical device registration in Brunei

[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!

 

[Ronen E]

Hi,

Based on this, it seems that Brunei is on track to implementing the ASEAN Medical Device Directive (AMDD).

 

[angwm]

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]

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]

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?