Philippines CMDL (Certificate of Medical Device Listing)

#1
Dear all,
this is my first post and I hope to give and receive helo concerning medical device regulatory affairs!
Nice to meet you!

I'm looking for support concerning the CMDL - Certificate of Medical Device Listing, as an option to enter medical device in Philippines, for a European Manufacturer.

According to the last FDA Circular N. 2020-001 (here enclosed), CDRRHR also accepts submission on the medical devices strictly for “research, clinical trial, exhibit, personal use and/or donated, brand new medical devices”, without need of notification or registration.
Could someone clarify about the meaning of "Brand new medical devices", please?

In addition to the Application form here attached and downloadable on the FDA website, are there any additional requirements, in order to obtain this Certificate?
Is there any label requirement for the imported device?

Thanks a lot,
Simona
 

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