Regulatory Open Forum

​​Our company is considering registration of IVD and its analyzer in Cuba but do not have any information about their regulations.  The products are CEmarked and categorized in self declaration in EU and some of them are class 2 in US.  Can the product with CE mark be registered without additional data or documents in Cuba?  Are there any unique or special requirement in Cuba?
Any information would be appreciated.
Best regards,
Toru

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Toru Murakumo RAC
General Manager, Regulatory Affairs
LSI Medience Corporation
Tokyo
Japan
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It is my understanding that Cuba operates the same as other PAHO (Pan-American) countries. Cuba has a regulatory agency (CECMED - http://www.cecmed.cu/content/informacion-general) and classification system that is based off of the Global Harmonization Task Force recommended classifications. The regulations encompass recommendations and conditions outlined in GHTF documentation for: role of standards and assessment of medical devices; quality requirements; post- market surveillance; essential principles; labeling for medical devices. I'm looking forward to other's responses so I can learn more too.

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Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
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Original Message:
Sent: 07-Jul-2017 02:35
From: Toru Murakumo
Subject: IVD registration in Cuba

​​Our company is considering registration of IVD and its analyzer in Cuba but do not have any information about their regulations.  The products are CEmarked and categorized in self declaration in EU and some of them are class 2 in US.  Can the product with CE mark be registered without additional data or documents in Cuba?  Are there any unique or special requirement in Cuba?
Any information would be appreciated.
Best regards,
Toru

------------------------------
Toru Murakumo RAC
General Manager, Regulatory Affairs
LSI Medience Corporation
Tokyo
Japan
------------------------------

​Thank you Michael for your response and comments.  I'm also looking forward to others comments for more information.
Kind regards,
Toru

------------------------------
Toru Murakumo RAC
General Manager, Regulatory Affairs
LSI Medience Corporation
Tokyo
Japan
------------------------------

Original Message:
Sent: 07-Jul-2017 15:03
From: Michael Nilo
Subject: IVD registration in Cuba

It is my understanding that Cuba operates the same as other PAHO (Pan-American) countries. Cuba has a regulatory agency (CECMED - http://www.cecmed.cu/content/informacion-general) and classification system that is based off of the Global Harmonization Task Force recommended classifications. The regulations encompass recommendations and conditions outlined in GHTF documentation for: role of standards and assessment of medical devices; quality requirements; post- market surveillance; essential principles; labeling for medical devices. I'm looking forward to other's responses so I can learn more too.

------------------------------
Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 07-Jul-2017 02:35
From: Toru Murakumo
Subject: IVD registration in Cuba

​​Our company is considering registration of IVD and its analyzer in Cuba but do not have any information about their regulations.  The products are CEmarked and categorized in self declaration in EU and some of them are class 2 in US.  Can the product with CE mark be registered without additional data or documents in Cuba?  Are there any unique or special requirement in Cuba?
Any information would be appreciated.
Best regards,
Toru

------------------------------
Toru Murakumo RAC
General Manager, Regulatory Affairs
LSI Medience Corporation
Tokyo
Japan
------------------------------