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Market Authorization for Apteryx Imaging Software Sales

Michael Satterfield
Updated

Currently, Planet DDS has regulatory authorization to sell Apteryx Imaging medical device software (such as Apteryx or DCV) in the US and Canada only.

Occasionally we receive requests to sell medical device software into countries other than the US and Canada, where the ministry of health for that country doesn’t have a documented medical device regulatory approval process. In cases such as these, it is difficult to determine if we should sell to that country even though they appear to be unregulated. It is even more difficult to determine what the ramifications would be for an unauthorized sale.

For these reasons, we will adhere to our authorized markets (US and Canada) for medical device sales.

Previous research efforts are as follows:

Country

Date Researched

Notes

Addt’l Info

Bahamas

04/27/2022

Not much info available on medical device regulations. Site referenced in next column shows them as being without a medical regulatory approval process, but site is old. Bahamas ministry of health shows regulations for medical practitioners and drugs, but nothing about medical devices. Looks to be unregulated, but not enough info available to be reliable.

https://www.regdesk.co/countries-no-medical-device-regulations/

Bahamas ministry of laws

Barbados

04/26/2022

Barbados appears to be unregulated. Country has no medical regulatory approval process. No specific regulation on administrative pre-clearance or pre-approval of medical devices for admission into trade. All info researched is dated, unknown if reliable.

Lex Mundi Global Practice Guide

Barbados Health Services Act

Cayman Islands

06/09/2021

Pharmaceutical and medicines (including medical devices):

  1. In accordance with the Ministry of Health, Environment, Culture and Housing (HECH), medicinal products must be registered prior to their importation.

  2. An import permit issued by the Department of Agriculture is required before veterinary medicines can be imported.

  3. Regulations are in place concerning the registry and labelling requirement for medical products, which may also require a Health Certificate. A Health Certificate is also required for sample medical supplies.

  4. CFSs are required for: general medical device(s); active implantable medical device(s) and in vitro diagnostic medical device(s) as well as a mixture of the above devices. CFSs are issued by the Medicines and Healthcare Products Regulatory Agency (MHRA). Refer to the MHRA website for more information.

  5. A Certificate of Good Manufacturing Practice (GMP) is required to certify that the exporter’s manufacturing methods comply with the requirements of GMP under World Health Organization (WHO) guidelines.

  6. Medicines and medical devices are to bear a label stating the name and address details of the manufacturer.

 Items 4 and 5 above, and to a lesser extent item 3, preclude us from Cayman island sales.

CFS - Certificate of Free Sale. We don’t have one.

Croner-i Information Gateway