What will be the requirements for the importation of medical devices once the new regulatory system is implemented?

Only two documents will be required from the company who will be importing medical devices, the LTO and the CPR. For medical device that is for registration, a special certification will be issued stating that the product to be imported will be issued as a sample only for registration.

For exempted medical devices, a certificate of listing will be issued prior to the importation of the device.

These new requirement will be coordinated with the Bureau of Customs prior to its implementation.