Jamaica, Trinidad and Tobago Medical Device Regulations

tebusse

Involved In Discussions
Greetings,

Is anyone aware of any specific guidance available for medical device regulations in Jamaica? The Jamaican Ministry of Health has a medical device registration form on their website, but provides no guidance as to who is required to register. I have reviewed their Food and Drug Act, but it was developed in 1964 and amended in 1975/1996, but device regulations are not included.

Any assistance would greatly be appreciated.

Regards, Tonia
 

Stijloor

Leader
Super Moderator
Re: Jamaica Medical Device Regulations

A Quick Bump!

Can someone help Tonia?

Thank you very much!!
 

Marc

Fully vaccinated are you?
Leader
Re: Jamaica Medical Device Regulations

Another quick "Bump". My Thanks in advance to anyone who can help with this one!

Marc
 
B

Burgmeister

Re: Jamaica Medical Device Regulations

Anyone able to help at all as I am also looking for this information. Information on Trinidad would also be appreciated :D
 
M

MIREGMGR

Re: Jamaica Medical Device Regulations

Jamaica:

This PDF document https://www.jamaicatradeandinvest.org/pdf/vol5/section5_standards_regulations_approval_process.pdf

points to this website (broken link removed)

which provides this registration form (broken link removed)

which is to be submitted to the Ministry of Health, Pharmaceutical & Regulatory Affairs Department.

Unfortunately, the link on the above MoH page that would provide the details of the process was not implemented by the webpage builder. The webpage however does explain as an overview that some devices will be substantially reviewed to determine if they will be Registered, but those devices that are deemed to not require such a review are instead Approved.

My understanding is that in general a device may be Approved if the submitter provides documentation showing that the product has been on the market in USA, Canada and/or Europe, and perhaps other countries, for at least a year; is not specially regulated on account of risk in one of those jurisdictions; and has no history of recall or involvement in patient problems.

I don't see any indication from the available information that the necessary submittal and Approval process could be managed other than by a representative within Jamaica who can be face-to-face at the MoH.
 
B

Burgmeister

Re: Jamaica Medical Device Regulations

Thanks for that MIREGMGR. I had found the form and had a good look at it but some of the questions on it seem rather bizarre for a medical device. I also noted that the link to further info wasn't working, nor was the webmail query page! Managed to type my query in but it didn't get sent.

So from what you have read you would be of the opinion that this could only be handled by a local distributor.

Thanks
 
Q

qualitymanager

Re: Jamaica Medical Device Regulations

If you are still interested in this (and still on the forum), I can find out from some of my Jamaican colleagues what the situation is.
 

tebusse

Involved In Discussions
Re: Jamaica Medical Device Regulations

Yes, I'm still interested in this forum and would greatly appreciate the information.
 
B

Burgmeister

Re: Jamaica Medical Device Regulations

Hi Qualitymanager, yes still on the forum and yes still very much interested. That would be great thanks.

Cheers
 
Last edited by a moderator:
Q

qualitymanager

Re: Jamaica Medical Device Regulations

Ok - I'll send out the messages now.

Pls remind me next week so I can check for updates from them.

I will follow-up via PM.
 
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