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Medical Device Regulations in Bermuda

#1
I need to find out what are the regulatory requirements for distributing medical devices in Bermuda. I've called the MOH several times this week with no response. Anyone out there that can help me?:bigwave:
 

yodon

Staff member
Super Moderator
#4
Can't help but maybe try checking the Emergo web site (I'm not affiliated with them, just found it helpful at times). They have a pretty extensive list of countries / requirements so maybe something there.
 
#5
I need to find out what are the regulatory requirements for distributing medical devices in Bermuda. I've called the MOH several times this week with no response. Anyone out there that can help me?:bigwave:
Hi dsudduth,
Have you received any information about Bermuda? I have the same question and we are getting conflicting opinions on how to interpret the requirements.
Thanks,
JJ
 
#7
Well, this is what I figured out as it pertains to our medical device (Medical CO2 Laser System). Bermuda (an island territory of the UK, which is part of the EU) will allow products into the country if they are either; CE marked, approved by either U.S., Canada or Japan. They also request the occupational safety duties for the consignee.

For all other devices, from what I understand, Bermuda's Health Council will "monitor the credentials and qualifications of health professionals, their standards of practice and the safety and quality of care in healthcare facilities" therefore, they require the medical professional to register the equipment with the BHeC.

Not my first choice on how to ensure public safety but if the product has been authorized for sale in countries that are part of the MDSAP program for instance, or CE marked, then you shouldn't have a problem getting into Bermuda. I would however, anticipate some questions regarding C of C's, DoC's, etc.. from Bermuda customs.

I hope this helps answer some of the questions out there regarding Bermuda.

And just to throw this out there...I chose not to sell our products there due to the lack of adequate support with the current size of our organization. Sending loaner systems there, I felt would be basically giving them away if I needed to get a system back for evaluation if there were an adverse event. This may not be the case for larger organizations but something to consider if you do not have field support in this region.

Good luck and I hope this helps!

Regards,

JJ-
 
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