In registering medical devices and IVD medical devices in the Philippines, they must first be registered with The
The Center for Device Regulation, Radiation Health and Research (CDRRHR) dari
Philippine Food and Drug Administration (FDA), which is in charge of overseeing the regulation of medical devices. Companies that want to market or sell medical devices or IVD medical devices need a
License to Operate (LTO) which is obtained through the e-service
e-service issued by the Philippine FDA at the time of application has been approved.
The definition of a medical device from the Philippines is an instrument, apparatus, apparatus, apparatus, machine, apparatus, implant reagent and calibrator in vitro, software, material or other similar related articles intended by the manufacturer / product owner to be used, alone or in combination for humans for one or more purposes Diagnosis, Prevention, Monitoring, Treatment, Treatment, Alleviation or Compensation for injury.
On May 8, 2020, the Department of Health (DOH) has issued
Administrative Order No. 2016-0003”
Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003”. Medical device sellers are included in the list of companies that must have a
License to Operate (LTO) before importing, exporting, selling, manufacturing, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or other health product sponsorship activities.
To register for class A medical devices, currently being processed through the online medical device registration system or
e-notification portal systemand registration for class B, C, D and IVD medical devices is processed via email.
email.
n April 1, 2019, a new regulation has been implemented that requires Class A medical devices at risk to have a Certificate
Certificate of Medical Device Notification and Class B, C, and D require a
Certificate of Medical Device Registration issued by the FDA as one of the requirements for medical devices and IVD to be placed in the Philippine market.
– Certificate of Medical Device Notification (CMDN): is an authorization issued for a medical device that complies with all requirements for Medical device Notification.
– Certificate of Medical Device Registration (CMDR): is an authorization issued for a medical device that complies with all requirements for Medical Device Registration.