The medical device registration process by the FDA Philippines is being updated, to simplify and speed up the relevant procedures.
Now, if you want to register Medical Devices in the Territory, it could be no more necessary to send samples of the products to the local Regulatory Authority. This “exemption” depends on the availability of pictures of the devices that include technical details of the products and that are considered adequate by the FDA Philippines.
Further update, already executive, are:
– the possibility for the manufacturer to add/change the local Importers/Distributors;
– the access to installation records that the Distributor must collect in order to comply with the post-market requirements.
For further information: http://www.fda.gov.ph/233-list-of-laboratories-recognized-by-the-fda/medical-device-registration-requirements