Philippines: Old Certificate of exemption for Class B device and new LTO. How to proceed?

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franklymissshankly

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Hi all,

Not sure if anyone would have insight on this but thought I should try. We are a US based medical device company and we distributed one of our medical devices in the Philippines back in 2014 (under class B). The device was not registered but we had a certificate of exemption (which I understand is no longer valid).
Currently, we have a new distributor with a valid LTO in the Philippines. Can we begin selling the same device in the Philippines till March 2023 while we work on a CMDN application?

I'm using this blog using this as reference:

Any insight on how this process would work? I believe our device is not included in the Circular No. 2021-001-A list. Does it mean that the device can be sold within the Philippines as long as a valid LTO is provided at the port of entry? Thanks!
 
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