PH Philippinen
  • 11 - Medizintechnik

In vitro diagnostic test systems (ICS 11.100.10)

Draft Administrative Order No. ___ : Rules and Regulations Governing the Issuance of an Authorization for an In-Vitro Diagnostic (IVD) Medical Device Based on the ASEAN Harmonized Technical Requirements (12 page(s), in English)

Republic Act No. 9711, otherwise known as the "Food and Drug Administration Act of 2009", and its Implementing Rules and Regulations, declare that it is the policy of the state to insure the safety, efficacy and quality of IVD medical devices in the country so as to protect the health of the Filipino people.

The signing of the ASEAN Agreement on Medical Device Directive (AMDD) in 2014, mandated the Philippines to implement the following provisions to a) "require the person responsible for placing the IVD medical devices in that Member State or the authorized representative to register the IVD medical devices with the regulatory authority by of that Member State", b) "shall undertake all necessary measures to ensure that only IVD medical devices which conform to the AMDD may be placed on markets of that Member State" and c) "put in place an appropriate system for the registration of IVD medical devices with the Regulatory Authority of that Member State". The Department of Health through the Food and Drug Administration - Center for Device Regulation, Radiation Health and Research (CDRRHR) hereby adopt, issues and implement the AMDD guidelines on the registration of IVD medical devices and to provide the regulatory requirement and registration process.