Regulatory Open Forum

Hello, 

I am looking for information regarding registering finished medical devices in the Caribbean and Oceania territories. My research on the internet does not turn up a lot of results on this and I know it has been a topic of research for some time now. I have included some notes that I have accumulated over time but would like to know if they are accurate. I am assuming there are some import documentation that is needed at least. The territories I am looking at in regard to registering medical devices are: 

• Aruba - no regulations
• Bahamas - no regulations
• Bermuda - no regulations but if device is cleared in the US, Bermuda may request documentation about the device
• Cayman Islands
• Curacao - no regulations
• Dominican Republic - not strictly enforced
• Grenada
• Guam - US territory, FDA
• Jamaica - requires registration
• Netherlands Antilles (St. Maarten) - no regulations
• Northern Mariana Islands- US territory, FDA
• Puerto Rico- US territory, FDA
• Saint Kitts and Nevis
• Saint Lucia
• Trinidad and Tobago - no regulations
• Virgin Islands - no regulations

Nina,

Many of the countries you listed indeed do not have specific medical device regulations - they usually rely on home-country approval or a "main" approval type such as US 510(k)/PMA or EU CE Mark.  Some of them have a registration process and others manage it completely through the importation process.  Usually it is good to work with an in-country entity, importation entity, or commerce department to understand any specific requirements for importing medical devices into the country.  There are similar posts about this type of activity which also might give you some ideas.  Sadly there is not a central worldwide database for this, though WHO has some information https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/global-atlas-of-medical-devices. 

Hello, 

I am looking for information regarding registering finished medical devices in the Caribbean and Oceania territories. My research on the internet does not turn up a lot of results on this and I know it has been a topic of research for some time now. I have included some notes that I have accumulated over time but would like to know if they are accurate. I am assuming there are some import documentation that is needed at least. The territories I am looking at in regard to registering medical devices are: 

• Aruba - no regulations
• Bahamas - no regulations
• Bermuda - no regulations but if device is cleared in the US, Bermuda may request documentation about the device
• Cayman Islands
• Curacao - no regulations
• Dominican Republic - not strictly enforced
• Grenada
• Guam - US territory, FDA
• Jamaica - requires registration
• Netherlands Antilles (St. Maarten) - no regulations
• Northern Mariana Islands- US territory, FDA
• Puerto Rico- US territory, FDA
• Saint Kitts and Nevis
• Saint Lucia
• Trinidad and Tobago - no regulations
• Virgin Islands - no regulations

Note that there are 2 "virgin islands" jurisdictions: US Virgin Islands (VI) and British Virgin Islands (VG).

Nina,

Many of the countries you listed indeed do not have specific medical device regulations - they usually rely on home-country approval or a "main" approval type such as US 510(k)/PMA or EU CE Mark.  Some of them have a registration process and others manage it completely through the importation process.  Usually it is good to work with an in-country entity, importation entity, or commerce department to understand any specific requirements for importing medical devices into the country.  There are similar posts about this type of activity which also might give you some ideas.  Sadly there is not a central worldwide database for this, though WHO has some information https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/global-atlas-of-medical-devices. 

Hello, 

I am looking for information regarding registering finished medical devices in the Caribbean and Oceania territories. My research on the internet does not turn up a lot of results on this and I know it has been a topic of research for some time now. I have included some notes that I have accumulated over time but would like to know if they are accurate. I am assuming there are some import documentation that is needed at least. The territories I am looking at in regard to registering medical devices are: 

• Aruba - no regulations
• Bahamas - no regulations
• Bermuda - no regulations but if device is cleared in the US, Bermuda may request documentation about the device
• Cayman Islands
• Curacao - no regulations
• Dominican Republic - not strictly enforced
• Grenada
• Guam - US territory, FDA
• Jamaica - requires registration
• Netherlands Antilles (St. Maarten) - no regulations
• Northern Mariana Islands- US territory, FDA
• Puerto Rico- US territory, FDA
• Saint Kitts and Nevis
• Saint Lucia
• Trinidad and Tobago - no regulations
• Virgin Islands - no regulations

Nina,

Many of the countries you listed indeed do not have specific medical device regulations - they usually rely on home-country approval or a "main" approval type such as US 510(k)/PMA or EU CE Mark.  Some of them have a registration process and others manage it completely through the importation process.  Usually it is good to work with an in-country entity, importation entity, or commerce department to understand any specific requirements for importing medical devices into the country.  There are similar posts about this type of activity which also might give you some ideas.  Sadly there is not a central worldwide database for this, though WHO has some information https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/global-atlas-of-medical-devices. 

Hello, 

I am looking for information regarding registering finished medical devices in the Caribbean and Oceania territories. My research on the internet does not turn up a lot of results on this and I know it has been a topic of research for some time now. I have included some notes that I have accumulated over time but would like to know if they are accurate. I am assuming there are some import documentation that is needed at least. The territories I am looking at in regard to registering medical devices are: 

• Aruba - no regulations
• Bahamas - no regulations
• Bermuda - no regulations but if device is cleared in the US, Bermuda may request documentation about the device
• Cayman Islands
• Curacao - no regulations
• Dominican Republic - not strictly enforced
• Grenada
• Guam - US territory, FDA
• Jamaica - requires registration
• Netherlands Antilles (St. Maarten) - no regulations
• Northern Mariana Islands- US territory, FDA
• Puerto Rico- US territory, FDA
• Saint Kitts and Nevis
• Saint Lucia
• Trinidad and Tobago - no regulations
• Virgin Islands - no regulations

Hi Richard, 

Thank you so much for your response. It helps and I wish there was a central worldwide database for this! I agree with you that many countries are subject to more "main" approval types as you mentioned.  I will relay this info!

Nina,

Many of the countries you listed indeed do not have specific medical device regulations - they usually rely on home-country approval or a "main" approval type such as US 510(k)/PMA or EU CE Mark.  Some of them have a registration process and others manage it completely through the importation process.  Usually it is good to work with an in-country entity, importation entity, or commerce department to understand any specific requirements for importing medical devices into the country.  There are similar posts about this type of activity which also might give you some ideas.  Sadly there is not a central worldwide database for this, though WHO has some information https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/global-atlas-of-medical-devices. 

Hello, 

I am looking for information regarding registering finished medical devices in the Caribbean and Oceania territories. My research on the internet does not turn up a lot of results on this and I know it has been a topic of research for some time now. I have included some notes that I have accumulated over time but would like to know if they are accurate. I am assuming there are some import documentation that is needed at least. The territories I am looking at in regard to registering medical devices are: 

• Aruba - no regulations
• Bahamas - no regulations
• Bermuda - no regulations but if device is cleared in the US, Bermuda may request documentation about the device
• Cayman Islands
• Curacao - no regulations
• Dominican Republic - not strictly enforced
• Grenada
• Guam - US territory, FDA
• Jamaica - requires registration
• Netherlands Antilles (St. Maarten) - no regulations
• Northern Mariana Islands- US territory, FDA
• Puerto Rico- US territory, FDA
• Saint Kitts and Nevis
• Saint Lucia
• Trinidad and Tobago - no regulations
• Virgin Islands - no regulations

Hello, 

I am looking for information regarding registering finished medical devices in the Caribbean and Oceania territories. My research on the internet does not turn up a lot of results on this and I know it has been a topic of research for some time now. I have included some notes that I have accumulated over time but would like to know if they are accurate. I am assuming there are some import documentation that is needed at least. The territories I am looking at in regard to registering medical devices are: 

• Aruba - no regulations
• Bahamas - no regulations
• Bermuda - no regulations but if device is cleared in the US, Bermuda may request documentation about the device
• Cayman Islands
• Curacao - no regulations
• Dominican Republic - not strictly enforced
• Grenada
• Guam - US territory, FDA
• Jamaica - requires registration
• Netherlands Antilles (St. Maarten) - no regulations
• Northern Mariana Islands- US territory, FDA
• Puerto Rico- US territory, FDA
• Saint Kitts and Nevis
• Saint Lucia
• Trinidad and Tobago - no regulations
• Virgin Islands - no regulations